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IRCT20170812035642N5 IRCT 2025-04-18 Tehran University of Medical Sciences Comparison of the Effect of Dietary weight loss intervention along with the Acceptance and Commitment behavioral therapy with Dietary weight loss intervention on Eating disorders in Overweight and Obese Adults: A Cluster Randomized Controlled Trial study Comparison of the Effect of Dietary weight loss intervention along with the Acceptance and Commitment behavioral therapy with Dietary weight loss intervention on Eating disorders in Overweight and Obese Adults: A Cluster Randomized Controlled Trial study 2025-04-09 anticipated 130 Complete https://irct.ir/trial/82471 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization in this study was carried out in a two-stage cluster design. In the first stage, two centers were randomly selected from ten health community centers under the coverage of Tehran University of Medical Sciences using simple random sampling through randomization software. Subsequently, the selected centers were randomly assigned to either 1) the intervention group, which received a weight loss dietary intervention along with Acceptance and Commitment Therapy-based behavioral therapy, or 2) the control group, which received a weight loss dietary intervention. Participants in each group were then selected using convenience sampling at each center. 3 Condition 1: Eating disorders. Condition 2: Overweight and Obesity. Intervention 1: Intervention group: Individuals in this group receive three interventions: Weight Loss Diet, Acceptance and Commitment Behavioral Therapy intervention, and Physical Activity intervention. 1) Acceptance and Commitment Therapy intervention, consisting of 12 weekly 90-minute group sessions in health centers in Tehran, which is based on the principles and concepts of acceptance, cognitive dissonance, contact with the present, self as context, values, and commitment to behavior. The 12-session ACT treatment program addresses these concepts; Session 1: Getting to know and building relationships with group members, psycho-education, understanding cognitive fusion, mindfulness, and emotion from an ACT perspective, and distributing a questionnaire; Session 2: Discussing experiences and evaluating them, creating creative frustration, asking individuals to talk about their anxieties, and reviewing the effectiveness of the next week's practice; Session 3: Introducing the desire to experience emotion as an alternative to control, the degree of apparent success in controlling emotions, programming internal events, and practicing numbers; Session 4: Review of previous session experiences, behavioral task and commitment, introduction of fault-finding, application of cognitive fault-finding techniques, rest and reception, intervention in the performance of problematic language chains, weakening the alliance of self with thoughts and emotions; Session 5: Review of observer's task and behavioral commitment, showing the separation between self, inner experiences and behavior, observing self as a context, weakening self-concept and self-expression; Session 6: Performance assessment, application of mindfulness methods, conflict between experience and mind, rest and reception, modeling of exiting the mind, training in seeing inner experiences as a process; Session 7: Performance assessment, introduction of the concept of value, showing the dangers of focusing on results, discovering practical values ​​of life; Session 8: Identifying obstacles, committed action based on the ACT algorithm, recording individual goals; Session 9: Reasoning as causes, continuing mindfulness practice, practicing objectification; Session 10: Training in goal setting and committed action; Session 11: Explaining thought captivity, examining the thoughts we cling to and the fundamental role those thoughts play in life, and examining their role and impact on emotions in the form of group discussion and the role they play in our current behavior, teaching how to detach from thoughts, conducting group exercises; Session 12: Understanding the nature of desire and commitment, determining action patterns consistent with values, and conducting a post-test. 2) Weight Loss Diet intervention: In this study, the calculation of energy expenditure at rest is performed based on the Mifflin formula because the Mifflin equations are more accurate for estimating REE in all overweight and obese individuals. Then, total daily energy expenditure (TEE) is calculated, which is equal to the sum of three components: resting metabolism (REE), thermic effect of food (TEF) (which is generally assumed to be 10% of total daily energy expenditure (equivalent to 1.1)), and activity thermogenesis (AT) (which is the most variable component of TEE). In other words, TEE = REE x 1.1 x PAL (physical activity level), where the PAL coefficient is 1.3 in sedentary individuals, 1.5 in moderately active individuals, and 1.7 in highly active individuals. A calorie-restricted diet is essential to induce clinically meaningful weight loss. Obesity guidelines recommend a diet designed to achieve a deficit of 500–750 kcal/day, resulting in an average weight loss of 0.5–0.75 kg (1.0–1.5 lb) per week. Accordingly, women are often prescribed 1200–1500 kcal/day and men 1500–1800 kcal/day, with higher targets in the range of individuals with higher body weight (or physical activity level). The US Dietary Guidelines (2015) recommend that approximately 15–20% of daily calories come from protein, 20–35% from fat (with a maximum of 10% from saturated fat), and the remainder from carbohydrates (45–65%), particularly fresh fruits and vegetables. 3) Physical Activity intervention: In lifestyle interventions for overweight and obese individuals, physical activity recommendations are usually 150–180 minutes per week of aerobic activity, such as brisk walking or other types of moderate-intensity aerobic or strength training. Also, adding strength training twice a week to a physical activity regimen may protect against the muscle loss that occurs with age. Intervention 2: Control group: Individuals in this group receive two weight loss diet interventions and physical activity intervention. 1) Weight Loss Diet intervention: In this study, resting energy expenditure is calculated based on the Mifflin formula because the Mifflin equations are more accurate for estimating REE in all overweight and obese individuals. Then, total daily energy expenditure (TEE) is calculated, which is equal to the sum of three components: resting metabolic rate (REE), thermic effect of food (TEF) (which is generally assumed to be 10% of total daily energy expenditure (equal to 1.1)), and activity thermogenesis (AT) (which is the most variable component of TEE). In other words, it can be said: (physical activity level) TEE = REE x 1.1 x PAL, where the PAL coefficient is 1.3 in sedentary individuals, 1.5 in moderately active individuals, and 1.7 in highly active individuals. A calorie-restricted diet is essential to induce clinically significant weight loss. Obesity guidelines recommend a diet designed to achieve a deficit of 500–750 kcal/day, resulting in an average weight loss of 0.5–0.75 kg (1.0–1.5 lb) per week. Accordingly, women are often prescribed 1200–1500 kcal/day and men 1500–1800 kcal/day, with higher goals in the range for those with higher body weight (or physical activity level). The US Dietary Guidelines (2015) recommend that approximately 15–20% of daily calories come from protein, 20–35% from fat (with a maximum of 10% from saturated fat), and the remainder from carbohydrates (45–65%), particularly fresh fruits and vegetables. 2) Physical Activity intervention: In lifestyle interventions for overweight and obese individuals, physical activity recommendations are usually 150-180 minutes per week of aerobic activity, such as brisk walking or other types of moderate-intensity aerobic or strength training. Also, adding strength training twice a week to a physical activity regimen may protect against the muscle loss that occurs with age. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information available
public Sakineh Shabbidar
No. 44, Hojat Doost Alley, Naderi Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5742 s_shabbidar@tums.ac.ir Tehran University of Medical Sciences scientific Sakineh Shabbidar
No. 44, Hojat Doost Alley, Naderi Street, Keshavarz Boulevard
Tehran Iran (Islamic Republic of) 1417613151 +98 21 8895 5742 s_shabbidar@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Adults Aged 20-59 Years Overweight or obese people (Body Mass Index 25-40) Both genders Living in Tehran Willingness to participate in the Study 20 years 59 years Both Being pregnant or breastfeeding, or planning to become pregnant in the next 12 months Following a specific diet Current participation in a weight loss program or a behavioral therapy program Recent weight loss Serious medical conditions (such as diabetes, cancer, Alzheimer's, Parkinson's, liver and kidney diseases, history of stroke and heart attack, rheumatoid arthritis, and other chronic diseases as self-reported) Serious mental disorders (such as bipolar disorder, schizophrenia) Using medication for overweight and obesity Using medication for mental disorders History of bariatric surgery Smoking Current substance abuse or dependency Inability to perform physical activities E66 Overweight and obesity Lifestyle Lifestyle Intervention group: Individuals in this group receive three interventions: Weight Loss Diet, Acceptance and Commitment Behavioral Therapy intervention, and Physical Activity intervention. 1) Acceptance and Commitment Therapy intervention, consisting of 12 weekly 90-minute group sessions in health centers in Tehran, which is based on the principles and concepts of acceptance, cognitive dissonance, contact with the present, self as context, values, and commitment to behavior. The 12-session ACT treatment program addresses these concepts; Session 1: Getting to know and building relationships with group members, psycho-education, understanding cognitive fusion, mindfulness, and emotion from an ACT perspective, and distributing a questionnaire; Session 2: Discussing experiences and evaluating them, creating creative frustration, asking individuals to talk about their anxieties, and reviewing the effectiveness of the next week's practice; Session 3: Introducing the desire to experience emotion as an alternative to control, the degree of apparent success in controlling emotions, programming internal events, and practicing numbers; Session 4: Review of previous session experiences, behavioral task and commitment, introduction of fault-finding, application of cognitive fault-finding techniques, rest and reception, intervention in the performance of problematic language chains, weakening the alliance of self with thoughts and emotions; Session 5: Review of observer's task and behavioral commitment, showing the separation between self, inner experiences and behavior, observing self as a context, weakening self-concept and self-expression; Session 6: Performance assessment, application of mindfulness methods, conflict between experience and mind, rest and reception, modeling of exiting the mind, training in seeing inner experiences as a process; Session 7: Performance assessment, introduction of the concept of value, showing the dangers of focusing on results, discovering practical values ​​of life; Session 8: Identifying obstacles, committed action based on the ACT algorithm, recording individual goals; Session 9: Reasoning as causes, continuing mindfulness practice, practicing objectification; Session 10: Training in goal setting and committed action; Session 11: Explaining thought captivity, examining the thoughts we cling to and the fundamental role those thoughts play in life, and examining their role and impact on emotions in the form of group discussion and the role they play in our current behavior, teaching how to detach from thoughts, conducting group exercises; Session 12: Understanding the nature of desire and commitment, determining action patterns consistent with values, and conducting a post-test. 2) Weight Loss Diet intervention: In this study, the calculation of energy expenditure at rest is performed based on the Mifflin formula because the Mifflin equations are more accurate for estimating REE in all overweight and obese individuals. Then, total daily energy expenditure (TEE) is calculated, which is equal to the sum of three components: resting metabolism (REE), thermic effect of food (TEF) (which is generally assumed to be 10% of total daily energy expenditure (equivalent to 1.1)), and activity thermogenesis (AT) (which is the most variable component of TEE). In other words, TEE = REE x 1.1 x PAL (physical activity level), where the PAL coefficient is 1.3 in sedentary individuals, 1.5 in moderately active individuals, and 1.7 in highly active individuals. A calorie-restricted diet is essential to induce clinically meaningful weight loss. Obesity guidelines recommend a diet designed to achieve a deficit of 500–750 kcal/day, resulting in an average weight loss of 0.5–0.75 kg (1.0–1.5 lb) per week. Accordingly, women are often prescribed 1200–1500 kcal/day and men 1500–1800 kcal/day, with higher targets in the range of individuals with higher body weight (or physical activity level). The US Dietary Guidelines (2015) recommend that approximately 15–20% of daily calories come from protein, 20–35% from fat (with a maximum of 10% from saturated fat), and the remainder from carbohydrates (45–65%), particularly fresh fruits and vegetables. 3) Physical Activity intervention: In lifestyle interventions for overweight and obese individuals, physical activity recommendations are usually 150–180 minutes per week of aerobic activity, such as brisk walking or other types of moderate-intensity aerobic or strength training. Also, adding strength training twice a week to a physical activity regimen may protect against the muscle loss that occurs with age. Control group: Individuals in this group receive two weight loss diet interventions and physical activity intervention. 1) Weight Loss Diet intervention: In this study, resting energy expenditure is calculated based on the Mifflin formula because the Mifflin equations are more accurate for estimating REE in all overweight and obese individuals. Then, total daily energy expenditure (TEE) is calculated, which is equal to the sum of three components: resting metabolic rate (REE), thermic effect of food (TEF) (which is generally assumed to be 10% of total daily energy expenditure (equal to 1.1)), and activity thermogenesis (AT) (which is the most variable component of TEE). In other words, it can be said: (physical activity level) TEE = REE x 1.1 x PAL, where the PAL coefficient is 1.3 in sedentary individuals, 1.5 in moderately active individuals, and 1.7 in highly active individuals. A calorie-restricted diet is essential to induce clinically significant weight loss. Obesity guidelines recommend a diet designed to achieve a deficit of 500–750 kcal/day, resulting in an average weight loss of 0.5–0.75 kg (1.0–1.5 lb) per week. Accordingly, women are often prescribed 1200–1500 kcal/day and men 1500–1800 kcal/day, with higher goals in the range for those with higher body weight (or physical activity level). The US Dietary Guidelines (2015) recommend that approximately 15–20% of daily calories come from protein, 20–35% from fat (with a maximum of 10% from saturated fat), and the remainder from carbohydrates (45–65%), particularly fresh fruits and vegetables. 2) Physical Activity intervention: In lifestyle interventions for overweight and obese individuals, physical activity recommendations are usually 150-180 minutes per week of aerobic activity, such as brisk walking or other types of moderate-intensity aerobic or strength training. Also, adding strength training twice a week to a physical activity regimen may protect against the muscle loss that occurs with age. Eating disorders. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Eating Disorder Diagnostic Scale Questionnaire. Body Weight. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Digital scale. Body Mass Index. Timepoint: Beginning of the Intervention (Before the Start of the Intervention) and End of the Intervention (After the End of the 12-Weeks Intervention). Method of measurement: Wall Height Gauge and Digital Scale. Tehran University of Medical Sciences Approved 2025-02-04 Ethics committee of Tehran University of Medical Sciences No. 44, Hojat Doost Alley, Naderi Street, Keshavarz Boulevard Tehran Tehran Iran (Islamic Republic of)