Psychological Intervention to Reduce Weight Bias Internalization

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial to test the effects on WBI of a novel psychological intervention combined with standard behavioral weight loss (BWL) treatment, as compared to BWL alone. Participants will be a total of 72 men and women seeking weight loss, ages 18-65 years, with a body mass index (BMI) of 30 kg/m2 or above, 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 = 36) or the BWL + BIAS program (n = 36). All participants will attend weekly, 90-minute group meetings for 12 weeks (12 visits). In the BWL + stigma intervention, 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 12 weeks of weight loss treatment, participants will attend group meetings focused on weight loss maintenance, every-other-week from weeks 13-16 (2 visits), and monthly from weeks 17-26 (2 visits). Maintenance sessions in the BWL + stigma group will continue to incorporate discussion of WBI. Assessments - which include questionnaires and measurements of body weight - will occur at baseline and weeks 12 and 26. Weight will be measured at every group meeting for clinical purposes.

Official Title
-----------------
A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss

Conditions
-----------------
Stigmatization, Obesity, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: BWL
* Behavioral: BIAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible participants will be men and women ages 18-65 years. Participants must have obesity (defined as a BMI ≥ 30 kg/m2); 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, evidenced by a negative urine dipstick pregnancy test 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 with which to participate in conference calls 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; uncontrolled hypertension (blood pressure ≥ 160/100 mm Hg); experienced a cardiovascular event (e.g., stroke, myocardial infarction) in the last 12 months; lost ≥ 5% of their initial weight in the last 6 months; or have participated in individual or group psychotherapy in the last 3 months (due to the potentially confounding effects of receiving a simultaneous cognitive-behavioral intervention). Applicants who have recently participated in or are currently receiving counseling for concerns unrelated to mood, self-esteem, or weight (e.g. career, marriage, or grief counseling; caregiver support) may be eligible per Principal Investigator's discretion. Applicants with severe symptoms of mood (for example, 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. 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 12 months are not eligible to participate.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BWL + BIAS<br>The behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group will include standard BWL treatment (described in more detail in Intervention section) combined with a weight stigma-reduction intervention. During the initial 12 weeks, the weekly 60-minute BWL sessions will be followed by 30 minutes devoted to stigma-related content. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies specifically in the context of weight management. | Behavioral: BWL<br>* The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. 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 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.<br>Behavioral: BIAS<br>* Following 60 minutes of BWL treatment, the BIAS intervention will devote 30 minutes to stigma-related content. Session topics will include: 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 weight management. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies in the context of weight management.<br>|
| Active Comparator: Standard BWL<br>The Standard BWL group will receive weekly BWL sessions (described in more detail in Intervention section) for 12 weeks, followed by every-other-week and monthly weight loss maintenance sessions from weeks 13-26. BWL content will last for 60 minutes, with an additional 30 minutes in this group devoted to discussing recipes and food preparation. | Behavioral: BWL<br>* The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. 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 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Bias Internalization | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Bias Internalization | Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization) | Baseline to week 26 | 
| Weight Self-Stigma Questionnaire (WSSQ) | 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-FNE) (summed 6-30); higher scores indicate greater weight self-stigma | Baseline to week 12 | 
| Weight Self-Stigma Questionnaire (WSSQ) | 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-FNE) (summed 6-30); higher scores indicate greater weight self-stigma | Baseline to week 26 | 
| Weight Bias | Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias) | Baseline to week 12 | 
| Weight Bias | Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias) | Baseline to week 26 | 
| Weight-Related Quality of Life | Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life) | Baseline to week 12 | 
| Weight-Related Quality of Life | Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total score and five subscales of Physical Function, Self Esteem, Sexual Life, Work, and Public Distress (transformed scores 0-100; higher scores indicate better quality of life) | Baseline to week 26 | 
| Perceived Stress | Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress) | Baseline to week 12 | 
| Perceived Stress | Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress) | Baseline to week 26 | 
| Depression | Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression) | Baseline to week 12 | 
| Depression | Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression) | Baseline to week 26 | 
| Exercise Self-Efficacy | Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy) | Baseline to week 12 | 
| Exercise Self-Efficacy | Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy) | Baseline to week 26 | 
| Eating Self-Efficacy | Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy) | Baseline to week 12 | 
| Eating Self-Efficacy | Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy) | Baseline to week 26 | 
| Percent Weight Change | Estimated mean change in percent weight change. Weight measured in kilograms (kg). | Baseline to week 26 | 
| Waist Circumference | Estimated mean change in waist circumference (cm). | Baseline to week 26 | 
| Blood Pressure | Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication. | Baseline to week 26 |