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LITHUANIAN UNIVERSITY OF HEALTH SCIENCES

Medical Academy

Faculty of Public Health

Robert Žižka

WEIGHT CONTROL AND LIFESTYLE CHANGE

USING DR. MICHAEL GREGER’S DAILY DOZEN

AND 21 TWEAKS: DOES IT REALLY WORK?

A PILOT STUDY

Master Thesis

(Lifestyle Medicine)

Student: Robert Žižka Supervisor: Assoc. Prof. Aukse Domeikiene, PhD

Date: Signature: Date: Signature:

Consultant: Assoc. Prof. Peter Pribis, MD, DrPH Director of Didactic Program in Dietetics,

Nutrition and Dietetics Faculty, University of New Mexico, USA

Date: Signature:

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SUMMARY

Lifestyle Medicine / Master Thesis

WEIGHT CONTROL AND LIFESTYLE CHANGE USING DR. MICHAEL GREGER’S DAILY DOZEN AND 21 TWEAKS: DOES IT REALLY WORK? A PILOT STUDY

Žižka R.

Supervisor: Assoc. Prof. Doc. Dr. Aukse Domeikiene, MD, PhD

Consultant: Assoc. Prof. Peter Pribis, MD, PhD Faculty of Public Health, Medical Academy, Lithuanian University of Health Sciences, Kaunas; 2021. 55 p.

Introduction

In this pilot study extensive evidence-based knowledge combined with a patient-centered approach was used for weight control and lifestyle change.

Aim of the work

To assess Dr. M. Greger’s Daily Dozen & 21 Tweaks approach to weight control with overweight and/or obese participants while using communicative and motivational techniques.

Objectives

1. To determine the number of lifestyle and nutrition changes feasible to be used simultaneously while using individual as well as a group motivational technics. 2. To assess what results in weight loss and lowering of risk factors for chronic diseases can be achieved in four weeks using plant-based diet and a number of evidence-based weight-loss boosters.

3. To assess in a 4-week follow-up to what extent the achieved lifestyle, weight control and risk factor changes are long-lasting.

4. To assess barriers and facilitators to a sudden and extensive change in nutrition and lifestyle habits.

Methods

Eight overweight or obese subjects participated in a 12-week weight loss trial divided in three 4-12-week periods – preparation, intervention, and follow-up. Individual as well as group meetings were organized. Questionnaires were used to assess data on participants’ eating habits and lifestyle, as well as their mental health status. Physical examination and laboratory tests to assess risk

factors were done. During first two periods participants were receiving intensive support by the Principal

Investigator. Mixed study design, combining

quantitative and qualitative methods was used. Statistica 12.0 software package, and Kolmogorov-Smirnov tests were used to analyze the quantitative data. Thematic analysis was used for the analysis of the qualitative data.

Results

Participants were able to complete the program comprising 61 interventions per day by 81%. A mean 6.7 kg (6.8%) weight loss was achieved. BMI decreased by 2.1 kg/m2 and LDL cholesterol by 0.9 mmol/l.

Depression and anxiety levels decreased by 68% and by 62%, respectively, sleep quality improved by 43%. During the 4-week follow-up compliance with the program decreased by 27%. Weight loss and mental health improvements remained persistent, lipids, and glucose returned to the baseline levels. Complexity of the weight loss/lifestyle program, distastes to certain foods and/or ingredients, and eating outside of home were identified as main barriers. Absence of feeling hungry, refining of tastes, excellent efficiency of the program, individual and group support provided by the Principal Investigator, and learning new skills were identified as main facilitators.

Conclusions

1. We were able to show that it was possible for the participants to adopt a large number of lifestyle and nutrition changes simultaneously.

2. Substantial normalization in weight, normalization in risk factors and mental health were achieved in four weeks on a whole-food plant-based diet while using a number of evidence-based weight-loss boosters. 3. Weight loss and mental health improvements were still persistent at the end of 4-week follow-up phase, while some improvements of risk factors (lipids, glucose) returned to the baseline levels.

4. Participants were able to overcome barriers and dramatically change their eating habits and lifestyle. These achievements lasted into the follow-up phase.

Key words

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3

SUMMARY

Gyvensenos medicina / Magistro baigiamasis darbas SVORIO KONTROLĖ IR GYVENSENOS

POKYČIAI NAUDOJANT DR. MICHAEL GREGER METODIKĄ „12 POKYČIŲ KASDIEN“ IR „21 TIKSLAS“: AR TAI VEIKIA? BANDOMASIS TYRIMAS

Žižka R.

Mokslinė vadovė doc. dr. Auksė Domeikienė Konsultantas doc. Peter Pribis

Lietuvos sveikatos mokslų universiteto Medicinos akademijos Visuomenės sveikatos fakultetas. Kaunas; 2021. 55 p.

Įvadas

Šiame bandomajame tyrime kontroliuojant svorį ir keičiant gyvenseną buvo naudojamos moksliniais įrodymais grįstos žinios ir į pacientą orientuotas konsultavimas.

Darbo tikslas

Įvertinti dr. M. Gregerio „12 POKYČIŲ KASDIEN“ ir „21 TIKSLAS“ metodiką tikslu, sumažinti kūno svorį dalyviams, turintiems antsvorio ir (arba) nutukusiems, konsultuojant pacientus ir keičiant jų motyvaciją.

Darbo uždaviniai

1. Nustatyti, kokį pokytį gyvensenos ir mitybos pokyčių galima pasiekti vienu metu vykdant individualias ir grupines konsultacijas.

2. Įvertinti svorio ir kitų lėtinių ligų rizikos veiksnių pokyčius per 4 savaites taikant augalinę mitybą ir kitas moksliniais įrodymais pagrįstas svorio kontrolės technikas.

3. Įvertinti svorio ir gyvensenos rizikos veiksnių pokyčių išlaikymą po 4 sav. trukmės stebėjimo laikotarpio. 4. Įvertinti mitybos ir gyvensenos pokyčių sėkmės faktorius ir kliūtis.

Tyrimo metodika

Aštuoni nutukę arba turintys antsvorio asmenys dalyvavo 12 savaičių trukmės tyrime, padalintame į 3 po keturias savaites trukusius etapus: pasirengimo,

intervencijos ir stebėjimo. Buvo išvengta

stigmatizacijos, atlikti motyvuojantys pokalbiai, taip pat ir grupinės konsultacijos. Dalyvių mitybos įpročiai, gyvensena ir psichikos sveikatos būklė įvertinta

naudojant klausimynus. Atliktas fizinis pacientų ištyrimas ir laboratoriniai tyrimai. Pirmųjų tyrimo etapų metu dalyvius intensyviai palaikė pagrindinis tyrėjas. Tyrimo tipas - taikyti kiekybiniai ir kokybiniai metodai. Kiekybiniai duomenys analizuoti naudojant Statistica 12.0 programą ir Kolmogorovo-Smirnovo testą. Kokybiniams duomenims taikyta teminė analizė.

Rezultatai

Dalyviai sugebėjo įvykdyti 81 proc. visų programos pokyčių (jų kasdieną buvo 61). Svorio sumažejimo vidurkis - 6,7 kg (6,8 proc. kūno svorio). KMI sumažėjo vidutiniškai 2,1 kg/m2 ir MTL - 0.9 mmol/l. Depre-siškumo ir nerimastingumo simptomų raiška sumažėjo atitinkamai 68 proc. ir 62 proc., miego kokybė pagerėjo 43 proc. Per 4 stebėjimo savaites dalyvių įsitraukimas į programą sumažėjo 27 proc., svorio sumažėjimas ir psichikos sveikatos pagerėjimas išliko stabilus, kraujo lipidų kiekis ir glikemija grįžo į pradinį lygį. Svorio

mažinimo ir gyvensenos pokyčių programos

sudėtingumas, nepriimtinas kai kurių maisto produktų skonis, valgymas ne namuose buvo pagrindinės kliūtys. Alkio nejautimas, skonių išgryninimas, puikus programos įgyvendinimas, pagrindinio tyrėjo parama, teikta individualiai ir grupėje, naujų įgūdžių išmokimas buvo įvardinti kaip sėkmės faktoriai.

Išvados

1. Pavyko įrodyti, kad dalyviams įmanoma vienu metu įgyvendinti daug gyvensenos ir mitybos pokyčių. 2. Žymus svorio ir kitų lėtinių ligų rizikos veiksnių sumažėjimas ir psichikos sveikatos pagerėjimas buvo pasiektas per 4 savaites taikant augalinę mitybą ir kitas moksliniais įrodymais pagrįstas svorio kontrolės technikas.

3. Svorio sumažėjimas ir psichikos sveikatos pagerėjimas išliko stabilūs po 4 savaičių trukmės stebėjimo etapo, tuo tarpu kraujo lipidų kiekis ir glikemija grįžo į pradinį lygį.

4. Dalyviai sugebėjo pakeisti savo mitybos įpročius ir gyvenimo būdą ir šie pokyčiai išliko tvarūs per stebėjimo laikotarpį.

Raktiniai žodžiai

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4 Acknowledgements

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5 TABLE OF CONTENTS

ABBREVIATIONS AND CONCEPTS ... 6

INTRODUCTION ... 7

AIM AND OBJECTIVES OF THE WORK ... 8

1. REVIEW OF LITERATURE ... 9

1.1. Behavior change techniques ... 9

1.2. Daily Dozen ... 9

1.3. Twenty-One Tweaks ... 12

1.4. Weight loss barriers and facilitators ... 15

2. RESEARCH METHODOLOGY ... 16

3. RESULTS ... 24

3.1. Participants and their characteristics ... 24

3.2. Eating habits and lifestyle change ... 24

3.3. Weight control and risk factors ... 28

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6

ABBREVIATIONS AND CONCEPTS

ALT – alanine aminotransferase AST – aspartate transaminase BMI – body mass index BMR – basal metabolic rate FV – fruits and vegetables

GAD-7 – General Anxiety Disorder-7 GGT – gamma-glutamyltransferase HDL – high-density lipoprotein

LDL – low-density lipoprotein

PHQ-9 – Patient Health Questionnaire-9 PI – Principal Investigator

PSQI – Pittsburg Sleep Quality Index RCT – randomized controlled trial TSH – thyroid-stimulating hormone WFPB – whole-food plant-based

WHO-5 – World Health Organization Well-Being index

Weight management (control) is the phrase used to describe both techniques and underlying physiological processes that contribute to a person's ability to attain and maintain a certain weight. Most weight management techniques encompass long-term lifestyle strategies that promote healthy eating and daily physical activity. [1]

The lifestyle of a particular person or group of people is the living conditions, behavior, and habits that are typical of them or are chosen by them. [2]

Lifestyle Medicine is a branch of medicine dealing with research, prevention and treatment of disorders caused by lifestyle factors such as nutrition, physical inactivity, and chronic stress. Lifestyle Medicine focuses on educating and motivating patients to change personal habits and behaviors around the use of whole foods, plant-predominant dietary lifestyle, regular physical activity, restorative sleep, stress management, avoidance of risky substances and positive social connection. [3]

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7

INTRODUCTION

In December 2015 Dr. Michael Greger published his book “How Not to Die – Discover the Foods Scientifically Proven to Prevent and Reverse Disease”. Here the physician behind the popular website NutritionFacts.org revealed “the groundbreaking scientific evidence behind the only diet that can prevent and reverse many of the causes of disease-related death”. [5]

In December 2019 he published another book: “How Not to Diet – The Groundbreaking Science of Healthy, Permanent Weight Loss”. In this book Dr. Greger describes the optimal criteria to support weight loss, and shows how plant-based eating is crucial for the success. But “How Not to Diet goes beyond food to identify twenty-one weight-loss accelerators available to our bodies, incorporating latest discoveries in cutting-edge areas like chronobiology to reveal the factors that maximize our natural fat-burning capabilities”. [6]

There is a strong scientific evidence behind both of these research projects. First book’s conclusions and recommendations are based on results of 2,800 scientific studies, while the second has 5,000 references.

In April 2019 I attended 5th International Lifestyle Medicine Conference in Kaunas, Lithuania, and in September of the same year I began to study Lifestyle Medicine, an innovative Master's degree program at the Lithuanian University of Health Sciences (LSMU). [7] It is a program designed for health care professionals in various fields seeking to improve their knowledge of lifestyle medicine (nutrition, physical activity, stress management, social support, and environmental control) and to enhance their professional career opportunities. (In 2019 the LSMU Lifestyle Medicine study program was awarded the prestigious Award of Excellence by American College of Lifestyle Medicine.)

During the study process I’ve learned much more than anticipated. One of many excellent materials that caught my attention was European Practical and Patient-Centered Guidelines for Adult Obesity Management in Primary Care. [8] There its authors formulated a novel approach for General Practitioners for the treatment of obesity – favoring a practical patient-centered approach, focused on quality communication, motivational interviewing as well as on therapeutic patient education, while highlighting the importance of avoiding stigmatization. Consistent evidence from an extensive systematic review showed that behavioral and cognitive determinants that promote a reduction in energy intake, an increase in energy expenditure and monitoring of this balance were predictive determinants for weight loss maintenance. [9]

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8 But – does it have to be so? Isn’t there a universal solution to this problem? At least for some? I have decided to combine the best available knowledge with a patient-centered approach, utilizing work in groups and modern technologies in a twelve weeks weight loss trial. This is a pilot project. In this study I have combined qualitative and quantitative design – to learn more about the patients and the ways they were coping (physically, mentally, and socially) with a sudden and extensive change in their nutrition and lifestyle habits.

Lastly, since Dr. Michael Greger’s book How Not to Diet (with all the weight boosters) was published only ten months ago to my knowledge this is the first pilot study to test the effectiveness of the interventions described there.

AIM AND OBJECTIVES OF THE WORK

Aim: To assess viability and results of Daily Dozen & 21 Tweaks approach to weight control with overweight and/or obese participants consulting lifestyle medicine specialist while using communicative and motivational techniques.

Objectives:

1/ Determine the number of lifestyle and nutrition changes feasible to be realized simultaneously while using motivational technics and an individual as well as a group approach.

2/ Assess what results in weight control and lowering of risk factors for chronic diseases can be achieved in four weeks using plant-based diet plus a number of evidence-based weight-loss boosters.

3/ Assess in a 4-week follow-up to what extent the achieved lifestyle, weight control and risk factors’ changes are durable.

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9

1. REVIEW OF LITERATURE

1.1. Behavior change techniques

Both motivational interviewing and multimedia education have been found effective in changing the lifestyle – self‑care, mental health, and physical activity was significantly better. [10] A systematic review and meta-analysis of randomized controlled trials (RCTs) focused on diet and physical activity showed that instructions on how to perform a behavior, behavioral practice/rehearsal, demonstration of the behavior and action planning, as well as supervised physical activity, group sessions, contact with a dietitian and interventions of greater frequency and intensity were all associated with better outcomes in weight control. [11] An evidence review showed that a number of studies on health behavior change using mobile phone apps reported statistically significant effects in the direction of targeted behavior change. [12]

1.2. Daily Dozen

Based on his book Dr. Greger developed a phone app that allows to monitor the intake of twelve healthy foods (food groups) of the Daily Dozen – beans, berries, other fruits, cruciferous vegetables, greens, other vegetables, flaxseed, nuts, spices, whole grains, beverages, and exercise. Following such a diet can prevent and reverse many lifestyle diseases. [5]

Plant-based (vegetarian and vegan) diets are an effective strategy for improving nutrient intake. At the same time, they are associated with decreased all-cause mortality and decreased risk of obesity, type 2 diabetes, and coronary heart disease. [13] Many studies have shown that plant-based diets are beneficial for the weight loss too. A review of twelve studies that included more than 1,100 people found that those assigned to plant-based diets lost significantly more weight — about 2 kg over an average of 18 weeks — than those assigned to non-vegetarian diets. [14] A large study in over 200,000 people found that those who followed a healthy plant-based diet rich in vegetables, fruits, whole-grains, legumes and nuts had a significantly lower risk of developing heart disease than those following non-plant-based diets. [15] Another study with more than 200,000 people found that those who adhered to a healthy plant-based eating pattern had a 34% lower risk of developing diabetes than those who followed unhealthy, non-plant-based diets. [16]

1.2.1. Fruits and Vegetables

Fruits and vegetables (FV) are an important component of a whole-food plant-based (WFPB) diet. In Dr. Greger’s Daily Dozen App these are divided into five categories – berries, other fruits, cruciferous vegetables, greens, and other vegetables.

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10 micronutrients influence obesity-associated metabolic pathways, non-essential phytochemicals in fruit augment their anti-obesity effects, and consumption of fruits brings positive effect on gut microbial ecology. [17] In three large, prospective cohorts of 133,468 men and women, an increased intake of fruits was inversely associated with 4-year weight change.

In another study increased intake of several vegetables (total vegetables, tofu, and cauliflower) was inversely associated with weight loss. On the other hand, increased intake of starchy vegetables, including corn, peas, and potatoes, was associated with weight gain. Vegetables having both higher fiber and lower glycemic load were more strongly inversely associated with weight change compared with lower-fiber, higher-glycemic-load vegetables.

Evaluating specific subgroups of vegetables, increased intakes of cruciferous and green leafy vegetables was inversely associated with weight loss. Among subgroups of fruits, increased intakes of berries and citrus fruits were inversely associated with weight change. When different fruits were evaluated, increased intakes of several individual fruits (blueberries, prunes, apples/pears, strawberries, raisins/grapes, and grapefruit) were inversely associated with weight change over 4 years. [18]

Whole fruits and vegetables intake may influence weight through a variety of mechanisms including a reduction in eating rate, providing a satisfying, very-low to low energy density, low glycemic load or low-fat content. Also, FV are the primary source of dietary fiber, which can provide additional support for weight loss. [19]

1.2.2. Pulses

Replacing energy-dense foods with pulses (beans, lentils, chickpeas, and dry peas) has been shown to have beneficial effects on the prevention and management of obesity and related disorders, such as cardiovascular disease, diabetes and the metabolic syndrome. [20]

A systematic review and meta-analysis of 21 RCTs with 940 participants showed an overall significant weight reduction of -0.34 kg in diets containing dietary pulses (median intake of 132 g/day or 1 serving/day) compared with diets without a dietary pulse intervention over a median duration of six weeks. Findings from six trials suggested that dietary pulse consumption may reduce body fat percentage. [21]

1.2.3. Whole Grains

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11 Observational data suggest a 15-30% decrease in all-cause and cardiovascular related mortality, and incidence of coronary heart disease, stroke incidence and mortality, type 2 diabetes, and colorectal cancer when comparing the highest dietary fiber consumers with the lowest consumers. Clinical trials show significantly lower body weight, systolic blood pressure, and total cholesterol when comparing higher with lower intakes of dietary fiber. The risk reduction was greatest when daily intake of dietary fiber was between 25 g and 29 g. [23]

An umbrella review of twenty-one meta-analyses reported statistically significant positive benefits of fiber for reducing the incidence of type 2 diabetes, cardiovascular disease, and colorectal cancer and a modest effect on body weight, waist circumference, and body fat mass. [24]

1.2.4. Nuts and Seeds

Due to the high energy density of nuts and seeds, it was believed that their consumption could increase weight gain; however, it was observed that the consumption of this group of foods does not stimulate weight gain. In contrast, the ingestion of nuts can help to control satiety and increase thermogenesis. Consumption of these foods also promotes an increase in the quality of the diet, because they are rich in MUFAs, PUFAs, proteins, fibers, vitamins, minerals and bioactive compounds with antioxidant potential. Moreover, nut intake can help in the treatment of some chronic disease risk factors, such as glycemic and lipid metabolism, oxidative stress, and inflammation. [25] 1.2.5. Beverages

Studies of individuals dieting for weight loss or weight maintenance suggest a weight-reducing effect of increased water consumption. [26] Drinking 500 ml of water 30 minutes before each meal in conjunction with a hypocaloric diet led to greater weight loss in overweight or obese middle-aged and older adults. [27] Six RCTs used different strategies for weight loss achievement: increasing daily water intake, replacement of caloric beverages with water, and premeal water load. All the studies showed a weight loss effect after follow-up, ranged from -0.4 kg to -8.8 kg with a mean percentage of weight loss of 5.1%. The most effective intervention among the studies was the replacement of caloric beverages with water. [28]

1.2.6. Exercise

There is strong evidence that regular exercise contributes to body weight and fat loss, maintenance of body weight and fat reduction, and metabolic fitness in obesity. Endurance training appears to be the most effective in this respect. Moreover, exercise has the potential to alleviate the health consequences of obesity, even in the absence of weight loss. [29]

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12 program, even without hypocaloric diet, can show beneficial effects to reduce visceral adipose tissue with more than 30 cm2 (on CT analysis) in women and more than 40 cm2 in men, after 12 weeks. [30] 1.3. Twenty-One Tweaks

In his book How Not to Diet Dr. Greger identified twenty-one weight-loss boosters. “There are special foods shown in interventional studies to cause you to burn more fat, suppress your appetite, rev up your metabolism, block the absorption of calories, and effectively take away even more calories than they provide. What’s more, the context in which we eat matters too. The same number of calories eaten at a different time of the day, in a different meal distribution, or after different amounts of sleep can translate into different amounts of body fat.”

The following paragraphs is a short review of scientific evidence behind each one of these weight loss boosters.

1.3.1. Eat Less

Preload with Water and “Negative Calorie” Foods, Deflour Your Diet.

Older obese man and women randomized to drink about two cups of water thirty minutes before a buffet-style meal ate 13 percent less, resulting in seventy-four fewer calories consumed. [31]

Overweight men and women randomized to two cups of water before each meal were losing weight 44 percent faster. [32]

Eating a low-energy-dense first course enhances satiety and reduces meal energy intake. Consuming a large portion of a low-energy-dense food (e.g. vegetable salad) at the start of a meal may be an effective strategy for weight management. [33] Consuming a preload of low-energy-dense soup, in a variety of forms, is another strategy for moderating energy intake in adults. [34] Eating fruit at the start of a meal can reduce energy intake. [35]

People fed at dinner boiled rye berries ate less at lunch the next day, more than twelve hours later. [36] All rye breakfasts resulted in higher satiety ratings in the morning and afternoon compared with the isocaloric reference breakfast with sifted wheat bread. [37] The same goes for nuts and nut butters – people eating whole nuts were feeling fuller hours later throughout the day. [38]

1.3.2. Eat Mindfully

Enjoy Undistracted Meals and Follow the Twenty-Minute Rule.

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13 1.3.3. Drink Appropriately

Incorporate Vinegar, Green Tea, and Stay Hydrated.

During a three-month trial, compared to the placebo group, the group taking one daily tablespoon of vinegar steadily lost about a pound a month and the group taking two daily tablespoons were down a total of about five pounds. [42] Meta-analysis of 15 weight-loss studies showed that drinking green tea results in a significantly higher resting metabolic rate [43] and a consequent weight loss averaging about three pounds over twelve weeks. [44] In a study nine- to twelve-year-old overweight kids were told to increase their water intakes to the point their urine became straw-colored (pale yellow). Those who complied lost significantly more weight. [45] Results from a study involving more than a million students in New York City public schools showed that increased water access appeared to translate into less weight gain and lower likelihood of overweight kids. [46] 1.3.4. Make Your Life More Spicy

Use Black Cumin, Garlic Powder, Cumin, Ground Ginger, Cayenne Pepper, and Nutritional Yeast.

A systematic review and meta-analysis of randomized, controlled weight-loss trials found that about a quarter teaspoon of black cumin powder every day appears to reduce body mass index within a span of a couple of months. [47] A randomized, double-blind, placebo-controlled study has found that as little as a daily quarter spoon of garlic powder can reduce body fat. [48] In another study, compared to the placebo group, garlic treatment resulted in significantly lower weight and waist circumference in women with metabolic syndrome. [49] Overweight women randomized to add a half teaspoon of cumin to their lunches and dinners beat out the control group by four more pounds and an extra inch off their waists. [50]

Systematic review and meta-analysis of 14 RCTs among overweight and obese subjects showed that a quarter teaspoon to one and a half teaspoons of ground ginger significantly decreased body weight. [51] A meta-analysis of studies on capsaicin, whether in extract or pepper form, found that overweight individuals burned, on average, about an extra seventy calories a day compared to those in the control groups. [52] In a Korean study there were significant reductions in visceral fat among overweight adults randomized to use Korean fermented soybean-based red pepper paste compared to a placebo group. [53]

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14 1.3.5. Time Your Day and Night Activities

Front-Load Calories, Time-Restrict Eating, Fast After 19:00, Time Exercise, Sleep Sufficiently, and Weigh Twice Daily.

In a 12-week weight loss trial overweight and obese women that where eating bulk of their daily calories in morning and noon hours lost significantly more weight and an extra two inches off their waistline compared to a control group receiving the same number of calories but with a bulk in the afternoon and evening hours. [56]

Overweight individuals instructed to stick to a consistent 10-12 hour feeding window of their own choosing lost seven pounds within sixteen weeks. [57] In another study, obese men and women asked to restrict eating to the eight-hour window between 10:00 and 18:00 lost five pounds in twelve weeks. [58] When people stopped eating between 19:00 and 6.00 for two weeks, they lost about a pound each week compared to no time restriction. [59]

More than a dozen experiments published comparing the amount of fat burned in a fasted state versus a fed state found more fat was burned on an empty stomach. [60] Same amount of exercise, but more fat loss just because of timing.

Sleep duration, mostly short sleep, and sleep disorders have emerged as being related to increased cardio-metabolic risk, including obesity, hypertension, type 2 diabetes mellitus, and cardiovascular disease. Sleep deprivation tends to lead people to overeat by about 180-560 calories a day.[61] A twelve-week study that randomized overweight and obese individuals to a weight-loss intervention with or without sleep component found that the sleep group lost weight significantly faster. [62] Most of the weight loss when getting eight and a half hours of sleep a night was fat, whereas most of the weight loss when only getting five and half hours was lean body mass. In another study with more sleep participants ended up losing more than twice as much body fat. [63]

A systematic review of literature showed that frequent self-weighing is likely to improve weight outcomes in weight management interventions. [64] One study found that twice daily – upon waking and again right before bed – appeared superior to once a day (six pounds versus two pounds of weight loss over twelve weeks). [65]

1.3.6. Complete Intentions, and Use Trendelenburg.

Randomized controlled studies show forming new habits or breaking old ones can not only produce significant weight loss but, more importantly, help keep it off. [66] A narrative review found that 65 percent of participants achieved clinically significant, sustained weight loss by automating healthy behaviors into habits. [67]

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15 (head lower than legs) for a few hours could theoretically – by raising ANF level – offer the boost in fat metabolism and help lose weight. [69]

1.4. Weight loss barriers and facilitators

Weight reducing strategies should take into account the specific perceived barriers to weight loss diets faced by overweight or obese people, particularly situational barriers, stress and depression and food craving. [70] Among top weight loss barriers are problems with self-monitoring, too little physical activity, internal thought/mood cues, vacation/holidays, and social cues. [71] Barriers to lifestyle changes included logistical barriers such as time and cost, motivational barriers including tiredness or feeling unrewarded, environmental barriers such as not having access to safe places to exercise, emotional barriers such as having depressive and defeating thoughts, and relational barriers such as having unsupportive partner or prioritizing children's meal preferences.

Facilitators to lifestyle modification for weight management are structured approaches such as having balanced meals and support by health professionals, peers, friends or family. [72] Coaching was found to be an efficient, cost-effective method for combining formal education and treatment of health in the weight loss process. [73]

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16

2. RESEARCH METHODOLOGY

Type of research

This was a pilot study with eight study objects. I used mixed design in this research study. In the experimental part of the research interventions set of nutrition and lifestyle tools were used and consequent changes in weight and risk factors of major chronic diseases assessed. In the qualitative part of the research interviews with study subjects were organized – at the baseline and after the intervention. Thematic analysis of all the acquired material was produced. Since a lot of qualitative data were collected from each of the participants during the trial, a case analysis was done as well. Researched context and theoretical model

In the qualitative part of the research the main interest was to assess opportunities and barriers for a sudden and extensive change in nutrition and lifestyle habits. We were interested to learn to what extent patient-centered approach, focus on quality communication, motivational interviewing, working in groups and therapeutic patient education might be helpful in achieving these changes and overcoming possible barriers. We used thematic analysis to analyze data obtained from interviews with study subjects.

Organization of the research

Research project took twelve weeks overall. It was divided in three phases – preparation phase, intervention phase, and follow-up phase – each one lasting four weeks. Each phase had its specifics and focuses.

Researched contingent, sample of research and its formation method

People with overweight or obesity, wanting to make a change in their lifestyle and eating habits were targeted. The main goal was to assess whether Dr. Greger’s approach to weight control based on using his Daily Dozen & 21 Tweaks applications is viable.

Participants had to live in Prague or at its outskirts. They had to be overweight or obese (BMI >29 kg/m2), men and women 25 to 65 years of age.

Interventions, research instruments and data sources

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17 Preparation phase

During four weeks of the preparation phase, three individual meetings with each one of the participants and two group meetings were organized. Most of the meetings lasted 1.5 to 2 hours.

First meeting. – A structured questionnaire (Annex 1) was used to collect anamnesis from the participant, searching for endogenous as well as exogenous factors connected with his/her overweight or obesity. A quick physical examination was done. Each participant completed three simple standardized tests (Annex 2 and Annex 3 ) to assess his/her current mental health (depression, anxiety, emotional well-being status), and completed a sleep quality questionnaire (Annex 3). The aim of this first meeting was to learn as much as possible regarding participant’s physical, mental, social health, to learn about the stage of change he/she is, to assess his/her motivation, and make acquaintance with him/her.

Second meeting. – This meeting was a group session. Participants were introduced to the intervention using Dr. Greger’s Daily Dozen & 21 Tweaks application as well as to the overall organization of the study. Basic education about the importance of the WFPB diet for a weight control and better health was provided and a number of questions answered. Information materials were distributed and several WFPB cookbooks offered. A WhatsApp group was created titled “Healthy Weight Loss” and contacts interchanged. Timetable for upcoming meetings was approved. Participants were asked to fill a questionnaire to evaluate their current nutrition and lifestyle habits (Annex 4). They were asked to assess how they were doing in Daily Dozen & 21 Tweaks on average during the last week.

Third meeting. – This session was focused on personalized education of each of the participants, based on his/her unique character and situation. Realistic goals regarding weight loss were agreed upon. It was agreed as well that already before the start of the intervention phase participants might experiment and apply some of the measures included in Daily Dozen & 21 Tweaks into their daily lives.

Fourth meeting. – This group session was a cooking class. The aim was to help participants to learn new things and get fresh ideas about the preparation of healthy and nutritious breakfasts and lunches. Food products provided by and cooperating health food warehouse were distributed among the participants. They were supplied with a 28-day load of whole grains, legumes, nuts and seeds, frozen berries, herbs and spices, tofu, polenta etc. to be used during the intervention phase. Participants paid for this purchase and found it very helpful, since it basically meant that in the month of intervention they wouldn’t need to buy anything else than fresh fruits and vegetables.

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18 were measured using a body fat monitor assessing their percent body, body fat mass, visceral fat etc. Participant’s fasting blood was drawn in a local EUC Laboratory to assess their fasting blood glucose, lipid profile: total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides; liver functions: alanine aminotransferase (ALT), aspartate transaminase (AST), and gamma-glutamyltransferase (GGT); kidney functions (urea, uric acid) , and TSH. In almost all cases these laboratory tests were done in a cooperation with participant’s GP and costs were covered by a health insurance company.

During the preparation phase the principal investigator (PI) communicated with participants according to their and his needs by phone, SMS, WhatsApp, and e-mails. The participants were instructed before the start of intervention phase to access and use a shared Google spreadsheet (Annex 5) to record each evening or latest next morning their achievements in Daily Dozen & 21 Tweaks during the day. For the study purposes the beginning of a new day was defined as the sunset. Intervention phase

For four weeks during the intervention phase study participants were asked to follow twelve measures included in Daily Dozen and twenty-one measures in 21 Tweaks as closely as possible.

They were asked to follow the Daily Dozen part (WFPB diet, beverages and exercise) at least 80% and the 21 Tweaks part (special weight-loss boosters) at least 70%. There was potentially a maximum of 61 points to be collected in total during every day. The participants were supposed to collect at least 19 points (80%) from Daily Dozen part and at least 26 points (70%) from 21 Tweaks part every day. That means that the goal they were presented with was to collect at least 45 points each day (73% of the overall score). Every morning the shared Google spreadsheet was checked by the PI collecting results from the preceding day. In case somebody’s data were missing, an SMS, WhatsApp message, e-mail or a phone call followed.

On a weekly basis, there were four group meetings and one individual meeting with each of the participants. Two times all participants met in a vegan restaurant to share a meal together, exchange ideas, experiences and to support each other. One group meeting was at the PI’s house where he prepared a WFPB meal for the participants. The aim of these meetings was to provide support and also to educate. During the intervention phase the PI repeatedly communicated with the participants by phone, SMS, WhatsApp, and e-mail. The purpose of these communications was to provide support.

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19 nutrition habits. In several months they will return to the same condition as before the start of the study. Or, they could continue to follow some part of the program. The outcome will depend on their individual characteristics, what parts of the program they will continue to follow, and how closely they will continue to follow the WFPB diet.

Study participants were not told anything about the follow-up. They were informed that there will be one more individual meeting with each one of them following the conclusion of the intervention phase. Purpose of this meeting being to collect evaluation and recommendations about the weight control program they’ve just participated in.

Individual meetings with each one of the participants were organized at the end of the intervention phase. Preceding this meeting, participants received by e-mail tests to assess their current mental health, and a sleep quality questionnaire. They were also asked to complete the nutrition and lifestyle questionnaire again. All this data was collected from them upon arriving. Data on participants’ body weight, blood pressure, and waist/hip circumference were collected. Participants were assessed using the body fat monitor.

Fasting blood was drawn from the participants assessing the same laboratory tests as in the beginning of the study.

Follow-up phase

During follow-up phase no support was given by PI to the participants. Individual meetings with each one of the participants were organized at the end of the follow-up phase, 28 days after the completion of the intervention phase. Preceding this meeting, participants received by e-mail the same tests to assess their current mental health, and a sleep quality questionnaire as in the beginning of the study. They were asked to complete the nutrition and lifestyle questionnaire again and to put into the shared Google spreadsheet their estimated average amount of servings per day regarding all 33 points involved in Daily Dozen & 21 Tweaks for the last two weeks. Data on participants’ body weight, blood pressure, and waist/hip circumference were collected. Participants were again measured using the body fat monitor.

Fasting blood was drawn from the participants at the same laboratory as in the beginning of the study. This time, costs for laboratory test were covered by PI’s supporting organization.

Researched instruments and data sources

Structured questionnaire (Annex 1) was used in the opening interview to collect anamnesis from the participant. The interview with the participants was recorded and later transcribed to provide data for thematic analysis for qualitative part of the study.

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20 Organization Well-Being index (WHO-5) questionnaires (see Annexes 2-3) were used. Standardized Pittsburg Sleep Quality Index (PSQI) was applied to measure the quality and patterns of sleep (see Annex 3). The purpose of all of these instruments was to evaluate barriers and to find out whether there would be any changes in these indicators during the 12-week research period.

Nutrition and Lifestyle Questionnaire (see Annex 4) was used to evaluate participant’s eating habits and lifestyle. Results added to the material collected during the opening interview and provided an estimated degree of participants’ health risks.

Shared Google Spreadsheet, developed on the base of Daily Dozen & 21 Tweaks mobile phone app (see Annex 5), was used to collect data from the actual intervention. The purpose was to evaluate the degree to which participants were following the program in its different stages.

Blood pressure and pulse were measured using Omron M10-IT. Waist and hip circumferences were recorded using a tape measure. Body weight, body mass index (BMI), body fat percentage, body water level, muscle and bone mass, physique rating, basal metabolic rate (BMR), metabolic age, and visceral fat were measured and calculated using TANITA BC-545N body composition monitor.

Semi-structured questionnaire (Annex 6) was used in the last interview to collect feedback from the participant. This interview with the participant was recorded and transcribed, to provide data for thematic analysis in qualitative part of the study.

Measuring instruments and their evaluation criteria

Structured questionnaire (see Annex 1) was used in the initial interview. Anamnesis was collected and factors potentially playing a role in participant’s overweight/obesity were searched for such as genetic predisposition, family profile, physiological factors and endocrine abnormalities. Participants were farther asked about their reasons for participation in the project, eating behaviors, lifestyle, motivation, stage of change, and current stress levels. The structured questionnaire was created on the basis of materials from the European Practical and Patient-Centered Guidelines for Adult Obesity Management in Primary Care. [75]

PHQ-9 (see Annex 2) was used to assess the level of depression. The PHQ-9 has nine items, each of which is scored 0 to 3, providing a 0 to 27 severity score. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression, respectively. Sensitivity to change and measurement invariance has been confirmed. [76]

GAD-7 questionnaire (see Annex 2) was used to assess the level of anxiety. It has seven items, each of which is scored 0 to 3, providing a 0 to 21 severity score. Scores of 5, 10, and 15 represent cut points for mild, moderate, and severe levels of anxiety, respectively. When screening for anxiety disorders, a recommended cut point for further evaluation is a score of 10 or greater. [77]

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21 possible and 25 representing best possibly quality of life. To obtain a percentage scoring ranging from 0 to 100, raw score is multiplied by 4. A percentage score of 0 represents worst possible, whereas a score of 100 represents best possible quality of life. It is recommended to administer the Major Depression Inventory (ICD-10) if the raw score is below 13 or if the participant has answered 0 to 1 to any of the five items. A score below 13 indicates poor wellbeing and is an indication for testing for depression under ICD-10. In order to monitor possible changes in wellbeing, the percentage score is used. A 10 % difference indicates a significant change. [78]

PSQI (see Annex 3) was used as to assess the quality and patterns of sleep. It measures seven areas of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month. A total score of 5 or greater is indicative of poor sleep quality. [79]

Nutrition and Lifestyle Questionnaire (see Annex 4) was used to evaluate eating habits and lifestyle and to assess participants’ estimated health risks. In this questionnaire positive nutritional factors, negative nutritional factors, and non-nutritional factors were identified. It’s a scale with twenty-two items, each of which (with one exception) is scored 0 to 5, providing total possible score of 105 score. Scores of 29, 49, 69, and 89 represent cut points for very high, high, important, low, and unimportant health risks, respectively. This questionnaire is extensively used in health clubs, at health expos and health immersion programs in the Czech Republic for last 15 years. [80]

Google Spreadsheet (see Annex 5), mirroring Dr. Greger’s Daily Dozen & 21 Tweaks mobile phone app, was used to collect data on participants’ compliance with the program during the intervention process. This mobile phone app was created using data in Dr. Greger’s books How Not to Die and How Not to Diet. The app measures portions of fruits and vegetables, whole grains, pulses, nuts and seeds, herbs and spices, and beverages consumed per day, as well as the use of specific weight loss boosters and activities (including exercise) done by a person each day. It’s a scale with twelve (Daily Dozen) plus twenty-one (21 Tweaks) items/servings, scored 0 to 1, 0 to 2, 0 to 3, and 0 to 5, providing total score of 61 score. [81]

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22

Table 2.1. Optimal ranges of blood markers in EUC Laboratories

Tanita BC-545N body composition monitor, uses advanced bioelectrical impedance analysis technology to measure and calculate body weight, BMI, body fat percentage, body water level, muscle and bone mass, physique rating, BMR, metabolic age, and visceral fat. Optimal ranges, dependent on the gender and the age of a person, were accessed at the company’s web pages. [82]

For thematic analysis, an original semi-structured questionnaire (see Annex 6) was developed to collect feedback regarding the program during the final interview.

Data encoding and transcription

For qualitative part of the research, interviews with participants were recorded and audio-recordings were transcribed verbatim. Specific items of data were then coded and organized.

Methods of data analysis

For thematic analysis we used methodology described in Qualitative Research in Psychology. [83] Interviews with participants were recorded and audio-recordings were transcribed verbatim. Familiarity with the data was achieved by repeated readings and some initial ideas were noted down. Meaningful segments were extracted from the material and coded with labels. Data relevant to potential themes were identified and gathered. A thorough analysis was done and a thematic map of the analysis generated.

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23 Research ethics

Research participants were verbally informed about their right to withdraw from participation in the study at any time.

Blood tests were analyzed at a certified EUC laboratories. During physical examinations a student researcher was measuring participants’ weight, blood pressure, waist circumference, and body fat. This was done in his office with another person present in the other room.

To ensure privacy and safety each participant was assigned a number under which all his/her data were collected. Personal data of research participants were collected and stored in a safe in a locked office with an alarm system.

Principles of the scientific integrity of research and other ethical principles of research were followed during the study. No actions causing damage to the participants enrolled into the research were taken – as it is laid down by the Law on the Rights of Patients and Compensation for the Damage to Their Health.

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24

3. RESULTS

3.1. Participants and their characteristics

Eight participants, four men and four women, from Prague and its outskirts, 28 to 59 years of age (mean 43.1 years), participated in the research. Four participants were with university degrees, one with a college degree, one was a high school graduate, and two were industrial school graduates. Four were full-time employed, two private entrepreneurs, and two on maternity leave.

At the baseline, one of the participants had 2nd grade obesity, five had 1st grade obesity, and two were overweight. Two participants had type 2 diabetes, as well as hypertension and high cholesterol levels, taking drugs for these conditions. Three participants had metabolic syndrome. The mean weight of the participants was 98.4 kg (range, 74.6 - 128.7 kg), mean BMI 32.8 (± 2.4) kg/m2, mean waist circumference 107.6 cm and mean hip circumference 117.1 cm. Mean body fat percentages were 27.9% for men and 39.9% for women. Mean LDL cholesterol was 2.83 mmol/l, three participants were out of the optimal range (having LDL cholesterol higher than 3.0 mmol/l), and two had high triglycerides.

At the baseline, two participants scored for mild, two for moderate, and one for moderately severe depression. Two scored for mild, and two for moderate level of anxiety. Poor well-being was found in two subjects and poor sleep quality in four participants. Mean scores regarding the importance of intervention and trust in the ability to make it were 7.2 and 8.1 (on a scale 0-10), respectively.

3.2. Eating habits and lifestyle change 3.2.1. Daily Dozen & 21 Tweaks app

Before the start of the study participants were collecting 9.8 ± 1.8 points in Daily Dozen part of the program, and 3.0 ± 1.4 points in Twenty-One Tweaks part of the program. Thus, they were fulfilling Daily Dozen from 41%, Twenty-One tweaks in 8% – and all the program in 21%. During the intervention phase they were collecting 20.6 ± 0.9 servings (p < 0.001) in Daily Dozen, and 29.1 ± 2.2 servings (p < 0.001) in Twenty-One Tweaks. It means that they were fulfilling Daily Dozen in 86%, Twenty-One Tweaks in 79% – and all the program in 81%. During the follow-up phase they were collecting 16.6 ± 2.0 servings (p < 0.001) in Daily Dozen, and 19.1 ± 2.7 servings (p < 0.001) in Twenty-One Tweaks. It means that they were fulfilling Daily Dozen in 69%, Twenty-One Tweaks in 52% – and all the program in 59%.

3.2.2. Eating habits and lifestyle factors

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25 Nutritional Factors, and 16.4 ± 6.4 points (i.e. 54%) in Other Lifestyle Factors. Overall the program was followed by 53%.

During the intervention phase they acquired 31.9 ± 2.7 points (p < 0.001) in Positive Nutritional Factors (i.e. 91%), 31.6 ± 7.4 points (p < 0.005) in Negative Nutritional Factors (i.e. 79%), and 22.0 ± 4.9 points (i.e. 73%) in Other Lifestyle Factors. Overall the program was followed by 81%. During the follow-up phase they acquired 28.9 ± 4.2 points in Positive Nutritional Factors (i.e. 83%), 28.8 ± 5.8 points (i.e. 72%) in Negative Nutritional Factors, and 20.1. ± 4.6 points (i.e. 67%) in Other Lifestyle Factors. Overall the program was followed by 74%.

Table 3.1 shows number of points acquired by the eight participants during the three phases of the study – before the start of the study (Initial), during the intervention phase (After), and during the follow-up phase (Foll.-Up).

Table 3.1. Eating habits and lifestyle of participants (in points) during the trial

3.2.3. Compliance to Daily Dozen & 21 Tweaks

During the intervention phase participants acquired 49.7 ± 2.8 servings (out of 61 possible) from both parts of the program on average per day.

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26

Fig. 3.1. Compliance to Daily Dozen during the intervention phase (in %)

In 21 Tweaks part participants excelled in preloading water (92%), negative calories (90%), using garlic powder (92%), ginger or cayenne (91%), staying hydrated (100%), weighing twice daily (89%), and getting sufficient sleep (95%). They were very good in eating without distraction (87%), following twenty-minute rule (87%), as well in time-restricting eating (84%). Good results were observed in deflouring diet (81%), and fasting after 19:00 (81%). Slightly lower compliance was with using green tea (79%), front-loading calories (77%), timing of exercise (77%), and completing intentions (76%). Some participants had problem to incorporate vinegar (61%), black cumin (67%), nutritional yeast (68%) and cumin (51%) into their diet. Nobody tried the Trendelenburg position (0%) Compliance to 21 Tweaks is presented in Fig. 3.2.

Of the 11,121 points collected by all the participants in the program during four weeks of intervention, 2,822 (25.4%) were gathered during the first week, 2,816 (25.3%) during the second week, 2,785 (25.0%) during the third week, and 2,698 (24.3%) during the fourth week.

0 20 40 60 80 100

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Fig. 3.2. Compliance to 21 Tweaks during the intervention phase (in %)

Based on the number of reported servings, participants were consuming on average per day: 278 ± 55 grams of beans, 57 ± 4 grams of berries, 373 ± 22 grams of other fruits, 38 ± 5 grams of cruciferous vegetables, 77 ± 23 grams of greens, 103 ± 14 grams of other vegetables, 12 ± 3 grams of flaxseeds, 29 ± 1 grams of nuts and seeds, 254 ± 41 grams of whole grains (mostly cooked), and ¼ teaspoon of turmeric (and/other spices). They were drinking 1.62 ± 0.14 liters of beverages (almost exclusively only water and green tea) and having 67 ± 13 minutes of aerobic exercise per day.

From the five main plant-based food categories participants consumed (calculation based on the number of servings per day): 430 grams of fruits, 218 grams of vegetables, 254 grams of whole grains, 278 grams of beans, and 41 grams of nuts and seeds, totaling 1,221 grams per day (see Fig. 3.3). Means and standard deviations of Daily Dozen and 21 Tweaks’ servings per day and participant during the 4-week intervention phase are presented in Annex 8.

3.2.4. Summary: Intervention phase

Compliance with Daily Dozen went up from 41% to 86% and compliance with Twenty-One Tweaks went up from 8% to 79%.

0 20 40 60 80 100

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Fig. 3.3. Average amounts of foods from five main plant-based food categories consumed during the intervention phase of the trial per day (in grams)

3.2.5. Summary: Follow-up phase

Compliance with Daily Dozen went down from 86% to 69% and compliance with Twenty-One Tweaks went down from 79% to 52%.

3.3. Weight control and risk factors of chronic diseases

In Annex 9 are presented the overall results including all the parameters measured during various phases of the trial.

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29 3.3.1. Weight control, BMI, waist and hip circumference

During the intervention participants lost on average 6.7 kg ± 2.9 kg (6.8% of their body weight). BMI decreased by 2.1 ± 0.8 kg/m2. During the 4-week intervention phase there was an average weight loss of 5.2 kg ± 1.6 kg (5.3%). In the same time period BMI decreased on average by 1.6 ± 0.3 kg/m2.

Waist circumference decreased on average by 6.8 ± 3.3% cm, hip circumference decreased on average by 4.3 ± 1.8% cm. Waist-to-hip ratio decreased on average by 0.02 ± 0.02 in the same time period. During the follow-up participants lost on average 0.2 kg ± 2.1 kg. BMI decreased on average by 0.2 ± 0.8 kg/m2. Waist circumference decreased by 0.7 ± 3.3% cm, hip circumference increased

by 0.8 ± 1.7%. Waist-to-hip ratio remained the same. Weight status of participants is in the Fig. 3.4. Mean weight of participants in different phases of the trial is in the Fig. 3.5.

Fig. 3.5. Mean weight of participants in different phases of the trial (in kg)

3.3.2. Body fat percentage, muscle mass, body water level, visceral fat

During the intervention the percent body fat decreased on average by 1.3 ± 1.8%, muscle mass decreased on average by 3.0 ± 2.2%, body water level increased on average by 0.8 ± 1.3%, and visceral fat decreased on average by 1.2 ± 0.8. During the follow-up the percent body fat decreased on average by 0.4 ± 1.5%, muscle mass increased on average by 0.4 ± 1.0%, body water level increased on average by 0.4 ± 1.1%, and visceral fat decreased on average by 0.1 ± 0.4.

3.3.3. Blood pressure, heart rate

During the intervention the systolic blood pressure decreased on average by 1.4 ± 18.5%, and diastolic blood pressure decreased on average by 0.5 ± 10.1%. Heart rate decreased on average by 10.3 ± 9.1 bpm in the same time period. During the follow-up systolic blood pressure decreased on

88,0 90,0 92,0 94,0 96,0 98,0 100,0

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30 average by 1.9 ± 12.9%, and diastolic blood increased on average by 1.8 ± 7.5%. Heart rate decreased on average by 1.9 ± 7.4 bpm in the same time period.

3.3.4. Lipids

During the intervention phase total cholesterol decreased on average by 1.03 ± 0.46 mmol/l , LDL cholesterol by 0.89 ± 0.31 mmol/l (p < 0.025), non-HDL cholesterol by 0.85 ± 0.44 mmol/l (p < 0.025), and triglycerides decreased on average by 0.24 ± 0.84 mmol/l. HDL cholesterol decreased on average by 0.18 ± 0.11 mmol/l. During the follow-up total cholesterol increased on average by 1.10 ± 0.91 mmol/l, LDL cholesterol increased on average by 0.92 ± 0.76 mmol/l, non-HDL cholesterol increased on average by 0.89 ± 0.83 mmol/l, and triglycerides increased on average by 0.33 ± 0.79 mmol/l. HDL cholesterol increased on average by 0.21 ± 0.15 mmol/l.

Mean lipid levels during the different phases of the trial are presented in Fig. 3.6. 3.3.5. Urea, uric acid, glucose and TSH

During intervention phase on average urea decreased 1.1 ± 0.6 mmol/l (p < 0.025), and uric acid decreased on average by 6 ± 34 μmol/l. Plasma glucose on average decreased 0.8 ± 1.3 mmol/l, and TSH decreased on average by 0.68 ± 1.27 mU/l in the same time period. During the follow-up urea on average increased by 0.5 ± 0.8 mmol/l, and uric acid decreased on average by 28 ± 24 μmol/l. Fasting plasma glucose increased on average by 0.8 ± 1.4 mmol/l, and TSH increased on average by 0.77 ± 0.69 mU/l in the same time period.

Fig. 3.6. Mean lipid levels during the trial (in mmol/l)

3.3.6. Liver tests

During intervention phase ALT decreased on average by 0.06 ± 0.11 μkat/l, AST increased on average by 0.03 ± 0.09 μkat/l and GGT decreased on average by 0.14 ± 0.24 μkat/l. During the

0,00 0,50 1,00 1,50 2,00 2,50 3,00 3,50 4,00 4,50 Total cholesterol HDL cholesterol Non-HDL cholesterol LDL cholesterol Triglycerides

Lipids (in mmol/l)

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31 follow-up phase ALT decreased on average by 0.05 ± 0.17 μkat/l, AST decreased on average by 0.05 ± 0.11 μkat/l and GGT increased on average by 0.16 ± 0.31 μkat/l.

3.3.7. Emotional and mental health, sleep quality

During the intervention WHO-5 index increased on average by 12% ± 16, while PHQ-9 score decreased on average by 5.1 ± 3.3 points, and GAD-7 score decreased on average by 3.5 ± 3.7 points. Sleep quality got better, PSQI score decreased on average by 2.3 ± 2.3 points. During follow-up WHO-5 index increased on average by 3% ± 12, PHQ-9 score increased on average by 0.4 ± 1.2 points, and GAD-7 score increased on average by 0.1 ± 2.4 points. Sleep quality improved, PSQI score decreased on average by 0.5 ± 1.4 points. Complete results of individual participants are presented in Fig. 3.7, Fig. 3.8, Fig. 3.9, and Fig. 3.10).

3.3.8. Summary: Intervention phase

At the end of the intervention on average a mean 6.7 kg (6.8%) weight loss was achieved. BMI decreased by 2.1 kg/m2 and waist circumference by 6.8 cm. Body fat percentage decreased by 2% in women and 0.6% in men. Only one participant had symptoms of a metabolic syndrome. Both participants with diabetes decreased their glucose levels – by 2.9 mmol/l and 3.0 mmol/l respectively. LDL cholesterol decreased on average by 0.9 mmol/l, all participants had optimal levels, and three reached the ideal range (under 1.8 mmol/l). Heart rate decreased on average by 10 bpm.

Fig. 3.7. WHO-5 index of participants during the trial (in %)

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Fig. 3.8. PHQ-9 of participants during the trial (in points)

3.3.9. Summary: Follow-up phase

At the end of follow-up weight decreased on average by 0.2 kg. Two participants continued to lose weight, two remained at the same level, three gained back 0.7 kg and one gained back 2.6 kg. Regarding lipids, most of the participants got back to their original levels (before the intervention), mean LDL cholesterol reaching 2.9 mmol/l (with three participants outside of optimal range) and mean total cholesterol 4.5 mmol/l. Plasma glucose levels with the two diabetics increased on average by 2.5 mmol/.

There were only minor changes (up and down) in mental health parameters since the end of intervention. Two participants scored for mild depression and two for mild anxiety, and all participants found their well-being very good. All participants also had good sleep quality.

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Fig. 3.10. PSQI of participants during the trial (in points)

3.3.10. Statistical analysis

Complete results of descriptive statistical analysis (means and standard deviations) of diet and lifestyle effects on clinical measures, sleep and mental health status of participants of all the measurements in various phases of the trial are presented in Annex 9.

Results of Kolmogorov-Smirnov tests during the three phases of the trial are presented in Annex 10. Minimal and maximal values, 25%-75% values and median values of all the measurements and tests during the trial are presented in Annex 11.

3.4. Case analysis

Complete results from physical examinations and laboratory measurements of participants during the trial are presented in Table 3.2, Table 3.3, Table 3.4, Table 3.5, Table 3.6, and Table 3.7. 3.4.1. Case 1

Anamnesis: A 32-year old male with 2nd degree obesity. Living with a girl-friend, father of a baby daughter. Industrial school graduate. Working as a technician, sitting all the time in the office. With a serious sleep apnea, on a breathing apparatus (needs oxygen) since a year and half. At the edge of metabolic syndrome. Taking vitamins to support his liver functions. Likes beer, meat and fast-food. Enjoys playing soccer. Takes the trial as a welcome chance for a major and much needed change. Motivated to lose weight and to do better. Supported by his family.

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34 Participant comments: The trial was very difficult for him during the first week. At the end of the intervention phase got rid of knee pains, and was able to walk seven floors upstairs with ease. Learned to eat breakfast, and to cook with a minimum amount of fat. No hunger, felt satiated all the time. Plans to continue losing weight, slowly but surely, heading under 100 kg threshold in a month or two.

At the end of follow-up phase he gained back 0.6 kg. Didn’t have much time to exercise lately. Eating meat three times a week. No chips. Struggling with quality of lunches. Still wanting to get under 100 kg in two months.

Table 3.2. Weight, body fat percentage, muscle mass, and BMI (in kg/m2)

of participants (with their sex and age) during the trial

3.4.2. Case 2

Anamnesis: A 59-year old male with 1st degree obesity, hypertension and hypercholesterolemia, type II diabetes, and metabolic syndrome. Married, father of a son (case 1) and daughter. Industrial school graduate. Working as a technician, on his feet most of the day. Feeling generally very well. Introduced into the study by his wife. Introverted, with a lot of energy. Likes cooking, eating, and walking. Gained 30 kg of weight during last five years when stopped doing sports. Declares that he is without a strong will.

Preparation and intervention phases: Managed to lose 2.3 kg (2%) of his initial body weight. His Waist (hip) circumference decreased by 2 cm. Emotional well-being and mental health remained excellent, sleep quality got significantly better (from 6 to 2). Total cholesterol decreased 0.9 mmol/l and LDL cholesterol 1.1 mmol/l. He continued to take pills for high cholesterol, diabetes and high blood pressure during the trial. His triglycerides decreased 0.9 mmol/l and glucose 3.0 mmol/l.

Participant comments: Surprised that he was not missing meat at all (had it only several times at social gatherings). Stopped eating processed meat entirely. Stopped worrying about fruits in the diet. Plans to have healthy large breakfasts every day and to lose more weight gradually.

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35 3.4.3. Case 3

Anamnesis: A 57-year old male on the verge of obesity, with type II diabetes, hypertension, and metabolic syndrome. Private entrepreneur, with a university degree. Married, with two grown-up children. Extraverted, positive, emotionally stable. Choleric and phlegmatic. Unstable regime at work (sometimes stressful). No regular times for meals. Likes eating rich foods, enjoys life at its fullest. Not a beginner in a healthy lifestyle, on and off the track for last 15 years. Likes playing ice hockey, travelling to exotic countries, walks with his dog.

Preparation and intervention phases: Managed to lose 5.3 kg (6%) of his initial body weight. Waist (hip) circumference decreased 3.5 cm (resp. 4.5 cm). His emotional and mental health improved. Total cholesterol decreased 1.8 mmol/l and LDL cholesterol 1.4 mmol/l. Triglycerides decreased by 0.8 mmol/l and glucose level decreased 2.9 mmol/l. GGT decreased from 1.4 ukat/l to 0.7 ukat/l.

Participant comments: Happy that his wife supported him. Liked WhatsApp group. Can imagine to follow this diet and lifestyle continually. Liked hot food, enjoyed cayenne pepper. Not losing breath so easily anymore. Prefers two big meals a day to 5-6 small meals. Never felt hungry. Learned to prepare breakfasts and cook legumes. Plans to lose three more kilograms in two months. At the end of follow-up phase he gained back 0.6 kg. Procrastinated a little bit, didn’t focus so much, stopped weighing himself, had some alcohol occasionally. Exercised less. Learned a lot, enjoys preparing breakfasts for himself, eating two meals per day. Plans to be more physically active and to follow the program more closely.

Table 3.3. Body water level, waist and hip circumference, plus waist-to-hip ratio of participants (with their sex and age) during the trial

3.4.4. Case 4

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36 aims to become more self-sufficient in food preparation. Never on a diet, never lost weight in the past.

Preparation and intervention phases: Managed to lose 10.5 kg (8%) of her initial body weight. Waist (hip) circumference decreased by 7 cm (resp. 6 cm). Emotional and mental health remained excellent, sleep quality got better (from 5 to 3). Total cholesterol decreased 1.2 mmol/l and LDL cholesterol 0.9 mmol/l.

Participant comments: It was not easy for him (strongest temptation being social gatherings), but took it as a challenge. During first week or two was quite hungry. Had some meat occasionally. In the second half of the trial managed to be on two big meals per day. Enjoyed support of his wife, and being in a group very much, felt that without that he would not succeed. Liked the Google spreadsheet for collecting results. Plans to continue in the program at least partially (good breakfasts, regular exercise, use herbs and spices, limit refined products, no food after 19:00). Aims to keep his weight loss permanent.

At the end of follow-up phase he gained back 0.7 kg. Kept having a good breakfast, moving more, not eating in the evening, drinking more water. Feels happy (with kilos lost) and in a good shape. Plans to follow the program partly in the future: eat only two substantial meals per day (breakfast and late lunch) – and learn how to prepare tasty bean dishes and homemade wholegrain bread.

Table 3.4. Total, LDL, HDL, and non-HDL cholesterol, plus triglycerides (all in mmol/L) of participants during the trial

3.4.5. Case 5

Anamnesis: A 34-year old female with 1st degree obesity, stressed and exhausted mother of

(37)

37 Preparation and intervention phases: Managed to lose 6.1 kg (7%) of her initial body weight. Waist (hip) circumference decreased by 9 cm. Depression level decreased from 7 to 1, anxiety level from 8 to 2. Total cholesterol decreased 0.7 mmol/l and LDL cholesterol also 0.7 mmol/l. She appreciated very much the group support.

Participant comments: Was surprised with the ease the intervention was managed by her body and mind. Happy and liberated, no longer feels stressed and guilty about her eating. Feels that never ate so cheaply in her life. Plans to lose 10 more kg in a year or so.

At the end of follow-up phase she lost two more kilograms. Learned to like vegan food very much. Needs some more healthy cooking classes – or somebody’s help to supply her with delicious vegan dishes. Stopped eating between main meals: having good breakfast, good lunch, and a light supper. Organic meat only once in a week or so. No dairy products, dislikes fatty meals, doesn’t need processed meat. Enjoyed running.

Table 3.5. Urea (in mmol/l), uric acid (in μmol/l), ALT, AST, and GGT (all in μkat/l) of participants during the trial

3.4.6. Case 6

Anamnesis: A 50-year old female with 1st degree obesity and metabolic syndrome. In her second marriage, taking care of four children aged 11 to 23. With a university degree, very active, working from home. Emotionally neglected by both of her parents. Stigmatized by her mother as being overweight since early childhood. Gained weight progressively during years. Extremely tired after two attacks of Lyme disease during the last five years. Can’t walk much because of a 4th degree

arthrosis in her legs, prefers bicycling. Experimented with veganism in last two years. Dislikes cruciferous vegetables.

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