Behavioral Weight Loss and Stigma Reduction

Study Overview
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Brief Summary
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This is a randomized controlled trial to test the effects on long-term weight loss of a novel stigma-reduction intervention combined with standard BWL treatment, as compared to BWL alone. Participants will be a total of 104 men and women seeking weight loss, ages 18 years and older, with a body mass index (BMI) of 30 kg/m2 or above (or 27 kg/m2 or above with an obesity-related comorbidity), a history of experiencing weight bias, and elevated levels of WBI. Participants will attend a screening visit in which they will complete a behavioral evaluation with a psychologist and a medical history that will be reviewed by a nurse practitioner or physician. Questionnaires assessing experiences and internalization of weight bias, with confirmation by interviewer assessment during the behavioral evaluation, will be used to determine whether participants meet criteria for having high levels of WBI. Eligible consenting participants will be randomly assigned to the standard BWL intervention (n = 52) or the stigma + BWL intervention (n = 52). All participants will attend weekly, 90-minute group meetings for 20 weeks (20 visits). In the stigma + BWL treatment group, 60 minutes will be devoted to BWL and 30 minutes to weight stigma. In the standard BWL treatment group, the additional 30 minutes will be devoted to sharing recipes and food preparation tips. Following 20 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, monthly from weeks 21-46 (6 visits), and every-other-month from weeks 47-72 (3 visits). Maintenance sessions in the stigma + BWL group will continue to incorporate discussion of WBI and stigma-related barriers to physical activity. Assessments - which include questionnaires, blood draws, and measurements of body weight and physical activity - will occur at baseline and weeks 20, 46 (no blood draw this week), and 72. Weight will be measured at every group meeting for clinical purposes.

Official Title
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A Randomized Controlled Trial of Behavioral Weight Loss and Stigma Reduction for Long-Term Weight Loss

Conditions
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Obesity

Intervention / Treatment
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* Behavioral: Stigma-Reduction Intervention
* Behavioral: Behavioral Weight Loss (BWL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants will be men and women ages 18 years and older. Participants must have obesity, defined as a BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with an obesity-related comorbidity. o Obesity-related comorbidities (which confer added CVD risk) will include: coronary heart disease; other atherosclerotic disease; sleep apnea; hypercholesteremia (i.e., high cholesterol, as diagnosed by doctor and/or if taking medication to lower cholesterol); and components of the metabolic syndrome, including hypertension (SBP ≥130, DBP ≥80 mm Hg, diagnosed by doctor and/or if taking anti-hypertensive medication); fasting blood glucose of 100-125 mg/dL (or prediabetes, diagnosed by doctor),; low HDL cholesterol (<40 mg/dL in men, <50 mg/dL in women), elevated triglycerides (>150 mg/dL, i.e., dyslipidemia diagnosed by doctor or taking medication to treat dyslipidemia), or elevated waist circumference (≥40 in for men, ≥35 in for women),. Eligible participants must also report a history of experiencing weight bias as assessed by self-report questionnaire and in-person interview, and have elevated levels of WBI as indicated by an average score of 4 (midpoint) or above on the Weight Bias Internalization Scale (WBIS) and by in-person interview. Participants must be seeking weight loss. If currently taking medications, dosages must be stable for at least 3 months. Participants will be eligible to participate if they exhibit mild to moderate severity of depression, anxiety, or binge eating disorder, as determined by the behavioral evaluation and the screening measures (Beck Depression Inventory-II and Questionnaire for Eating and Weight Patterns; see below for details). Elevated WBIS scores are often associated with these variables. Participants taking anti-depressant medication will be eligible if their dose has been stable for a minimum of 3 months. Eligible female patients will be: non-pregnant and non-lactating surgically sterile or postmenopausal, or they will agree to continue to use a method of birth control during the study Participants must: have a PCP who is responsible for providing routine care have reliable telephone service and/or email access with which to be in contact with the study team understand and be willing to comply with all study-related procedures and agree to participate in the study by giving written informed consent Exclusion Criteria: Applicants will be excluded if they have: a diagnosis of type I or II diabetes (for type II diabetes, blood glucose ≥126 mg/dL or A1C ≥6.5); uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg); experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months; lost and maintained ≥ 5% of their initial weight in the last 3 months or ≥ 10% in the past 2 years; or have participated in individual or group psychotherapy related to weight in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). o Participants who have recently received or are currently receiving therapy for a pre-existing mental health issue unrelated to weight (e.g., psychotherapy for depression or anxiety, or marriage, grief, or career counseling) may be eligible if the therapy is deemed by the Principal Investigator to be unlikely to affect weight, eating habits, or physical activity. Applicants with severe symptoms of mood (BDI-II score ≥ 29), anxiety, or binge eating disorder, and any severity of thought or substance use disorders will not be accepted into the study, as these symptoms may interfere with individuals' ability to adhere to a weight loss program. o Clinician judgment will be used to determine severity of mood disorder symptoms independent from obesity-related concerns and complications (e.g., fatigue), and decisions about applicants' eligibility based on psychiatric symptoms will fall within the Principal Investigator's discretion. Individuals with bulimia nervosa will not be eligible to participate, because weight loss may be contraindicated. Applicants with current, active suicidal ideation, and/or a suicide attempt within the past year will be excluded from the study and referred to psychiatric treatment facilities in the greater Philadelphia area. Applicants will not be eligible if they have a history of bariatric surgery. Women who are nursing, pregnant, or planning to become pregnant in the next 16 months are not eligible to participate. Applicants who report obtaining 150 minutes or more of structured physical activity per week (e.g., 30 minutes 5 days per week) will not be eligible, as they will already be obtaining the recommended amount of physical activity and may not be able to further increase their activity as part of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stigma + BWL Intervention<br>Participants in this group will receive the standard behavioral weight loss (BWL) program, which will be combined with a stigma-reduction intervention (more details provided in the Intervention section). All group meetings will be 90 minutes. Beginning at week 5, the 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the monthly and every-other-month weight loss maintenance sessions from weeks 21-72, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically with physical activity. | Behavioral: Stigma-Reduction Intervention<br>* Session topics will be based on those tested in a previous pilot study, including: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to physical activity. For example, they will be given strategies to cope with anticipated stigma while exercising in public spaces (e.g., while walking), as well as to challenge self-critical beliefs (e.g., that they are lazy) which may otherwise lead them to avoid exercising. These concrete strategies, along with reducing WBI and improving self-confidence, are intended to increase participants' self-efficacy for and engagement in physical activity.<br>Behavioral: Behavioral Weight Loss (BWL)<br>* This intervention will be based on the Diabetes Prevention Program. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are >10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity.<br>|
| Active Comparator: Standard BWL Intervention<br>Participants in this group will be provided with 20 weekly behavioral weight loss (BWL) session (described in more detail in the Intervention section), followed by 6 monthly weight loss maintenance sessions and 3 every-other-month sessions (for a total of 29 visits over 72 weeks). All group meetings will be 90 minutes. Beginning at week 5, BWL content in these sessions will last 60 minutes, with an additional 30 minutes devoted to discussing recipes and food preparation. | Behavioral: Behavioral Weight Loss (BWL)<br>* This intervention will be based on the Diabetes Prevention Program. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are >10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Weight Change at Week 72 | Estimated mean percent change in weight from baseline to week 72 | Baseline to week 72 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Loss of 5% or Greater of Initial Body Weight at Week 72 | The percentage of participants who lost 5% or greater of their initial body weight at week 72 | Baseline to week 72 | 
| Loss of 10% or Greater of Initial Body Weight at Week 72 | The percentage of participants who lost 10% or greater of their initial body weight at week 72 | Baseline to week 72 | 
| Percent Weight Change at Week 46 | Estimated mean percent weight change | Baseline to week 46 | 
| Percent Weight Change at Week 20 | Estimated mean percent weight change | Baseline to week 20 | 
| Loss of 5% or Greater of Initial Body Weight at Week 46 | The percentage of participants who lost 5% or greater of their initial body weight at week 46 | Baseline to week 46 | 
| Loss of 10% or Greater of Initial Body Weight at Week 46 | The percentage of participants who lost 10% or greater of their initial body weight at week 46 | Baseline to week 46 | 
| Loss of 5% or Greater of Initial Body Weight at Week 20 | The percentage of participants who lost 5% or greater of their initial body weight at week 20 | Baseline to week 20 | 
| Loss of 10% or Greater of Initial Body Weight at Week 20 | The percentage of participants who lost 10% or greater of their initial body weight at week 20 | Baseline to week 20 | 
| Change in Minutes of Physical Activity (Accelerometer) at Week 72 | Estimated mean change in daily minutes of physical activity, as measured by accelerometry | Baseline to week 72 | 
| Change in Minutes of Physical Activity (Accelerometer) at Week 46 | Estimated mean change in daily minutes of physical activity, as measured by accelerometry | Baseline to week 46 | 
| Change in Minutes of Physical Activity (Accelerometer) at Week 20 | Estimated mean change in daily minutes of physical activity, as measured by accelerometry | Baseline to week 20 | 
| Change in Energy Expenditure at Week 72 | Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure. | Baseline to week 72 | 
| Change in Energy Expenditure at Week 46 | Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure. | Baseline to week 46 | 
| Change in Energy Expenditure at Week 20 | Estimated mean change in energy expenditure, as measured by the Paffenbarger Physical Activity Questionnaire. Higher kilocalories (kcal) indicate greater energy expenditure. | Baseline to week 20 | 
| Change in Exercise Self-efficacy at Week 72 | Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy) | Baseline to week 72 | 
| Change in Exercise Self-efficacy at Week 46 | Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy) | Baseline to week 46 | 
| Change in Exercise Self-efficacy at Week 20 | Estimated mean change on the Self-Efficacy to Exercise Scale (total score 0-90; higher scores = greater self-efficacy) | Baseline to week 20 | 
| Change in Eating Self-efficacy at Week 72 | Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy) | Baseline to week 72 | 
| Change in Eating Self-efficacy at Week 46 | Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy) | Baseline to week 46 | 
| Change in Eating Self-efficacy at Week 20 | Estimated mean change on the Weight Efficacy Lifestyle Questionnaire - Short Form (total score 0-72; higher scores = greater self-efficacy) | Baseline to week 20 | 
| Change in Triglycerides at Week 72 | Estimated mean change in triglyceride concentration in blood | Baseline to week 72 | 
| Change in Triglycerides at Week 20 | Estimated mean change in triglyceride concentration in blood | Baseline to week 20 | 
| Change in Blood Pressure at Week 72 | Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg) | Baseline to week 72 | 
| Change in Blood Pressure Week 20 | Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg) | Baseline to week 20 | 
| Change in Weight Bias Internalization Scale Score at Week 72 | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization). | Baseline to week 72 | 
| Change in Weight Bias Internalization Scale Score at Week 46 | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) | Baseline to week 46 | 
| Change in Weight Bias Internalization Scale Score at Week 20 | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) | Baseline to week 20 | 
| Remission of Elevated Weight Bias Internalization at Week 72 | Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) | Baseline to week 72 | 
| Remission of Elevated Weight Bias Internalization at Week 46 | Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) | Baseline to week 46 | 
| Remission of Elevated Weight Bias Internalization at Week 20 | Percentage of participants who score below 4.0 on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) | Baseline to week 20 | 
| Change in Weight Self-stigma Scores at Week 72 | Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma. | Baseline to week 72 | 
| Change in Weight Self-stigma Scores at Week 46 | Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma. | Baseline to week 46 | 
| Change in Weight Self-stigma Scores at Week 20 | Estimated mean change score for Total score (WSSQ-Total, summed 12-60) and two subscales of Self-Devaluation (WSSQ-SD) and Fear of Enacted Stigma (WSSQ-FE) (summed 6-30); higher scores indicate greater weight self-stigma. | Baseline to week 20 | 
| Treatment Acceptability at Week 20 | To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability. | Week 20 | 
| Treatment Acceptability at Week 72 | To assess treatment acceptability, participants in both groups rated (1-7) how acceptable and helpful the program was, how much they liked the program, and how satisfied they were; scores for these 4 items were averaged. Participants also rated (1-7) the BWL treatment, as well as the stigma intervention (i.e., BIAS component) or recipe exchange, on how helpful they found each component of the program, how much they liked the components, and how much they learned. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Participants rated how much they learned BWL scores, and how much they learned and used skills related to stigma (all averaged 1-7). Higher scores indicate greater treatment acceptability. | Week 72 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Weight Stigma, Physical Activity, Cardiovascular Risk Factor