search
Back to results

Psychological Intervention to Reduce Weight Bias Internalization

Primary Purpose

Stigmatization, Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BWL
BIAS
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stigmatization

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Pennsylvania Center for Weight and Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BWL + BIAS

Standard BWL

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Weight Bias Internalization
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)

Secondary Outcome Measures

Weight Bias Internalization
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
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
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
Weight Bias
Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Weight Bias
Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
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)
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)
Perceived Stress
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Perceived Stress
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Depression
Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Depression
Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Exercise Self-Efficacy
Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Exercise Self-Efficacy
Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Eating Self-Efficacy
Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Eating Self-Efficacy
Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Percent Weight Change
Estimated mean change in percent weight change. Weight measured in kilograms (kg).
Waist Circumference
Estimated mean change in waist circumference (cm).
Blood Pressure
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.

Full Information

First Posted
June 4, 2018
Last Updated
September 30, 2020
Sponsor
University of Pennsylvania
Collaborators
Weight Watchers International
search

1. Study Identification

Unique Protocol Identification Number
NCT03572218
Brief Title
Psychological Intervention to Reduce Weight Bias Internalization
Official Title
A Randomized Controlled Trial of a Psychological Intervention to Reduce Weight Bias Internalization in the Context of Behavioral Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
Weight Watchers International

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stigmatization, Obesity, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BWL + BIAS
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard BWL
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BWL
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BIAS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight Bias Internalization
Description
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time Frame
Baseline to week 12
Secondary Outcome Measure Information:
Title
Weight Bias Internalization
Description
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time Frame
Baseline to week 26
Title
Weight Self-Stigma Questionnaire (WSSQ)
Description
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
Time Frame
Baseline to week 12
Title
Weight Self-Stigma Questionnaire (WSSQ)
Description
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
Time Frame
Baseline to week 26
Title
Weight Bias
Description
Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Time Frame
Baseline to week 12
Title
Weight Bias
Description
Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Time Frame
Baseline to week 26
Title
Weight-Related Quality of Life
Description
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)
Time Frame
Baseline to week 12
Title
Weight-Related Quality of Life
Description
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)
Time Frame
Baseline to week 26
Title
Perceived Stress
Description
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time Frame
Baseline to week 12
Title
Perceived Stress
Description
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time Frame
Baseline to week 26
Title
Depression
Description
Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Time Frame
Baseline to week 12
Title
Depression
Description
Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Time Frame
Baseline to week 26
Title
Exercise Self-Efficacy
Description
Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Time Frame
Baseline to week 12
Title
Exercise Self-Efficacy
Description
Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Time Frame
Baseline to week 26
Title
Eating Self-Efficacy
Description
Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Time Frame
Baseline to week 12
Title
Eating Self-Efficacy
Description
Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Time Frame
Baseline to week 26
Title
Percent Weight Change
Description
Estimated mean change in percent weight change. Weight measured in kilograms (kg).
Time Frame
Baseline to week 26
Title
Waist Circumference
Description
Estimated mean change in waist circumference (cm).
Time Frame
Baseline to week 26
Title
Blood Pressure
Description
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.
Time Frame
Baseline to week 26
Other Pre-specified Outcome Measures:
Title
Coping Behaviors in Response to Weight Stigma
Description
Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies
Time Frame
Baseline to week 12
Title
Coping Behaviors in Response to Weight Stigma
Description
Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies
Time Frame
Baseline to week 26
Title
Body Esteem
Description
Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)
Time Frame
Baseline to Week 12
Title
Body Esteem
Description
Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)
Time Frame
Baseline to Week 26
Title
Body Dissatisfaction
Description
Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)
Time Frame
Baseline to Week 12
Title
Body Dissatisfaction
Description
Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)
Time Frame
Baseline to Week 26
Title
Disordered Eating
Description
Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)
Time Frame
Baseline to Week 12
Title
Disordered Eating
Description
Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)
Time Frame
Baseline to Week 26
Title
Eating Behaviors
Description
Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger
Time Frame
Baseline to Week 12
Title
Eating Behaviors
Description
Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger
Time Frame
Baseline to Week 26
Title
Anxiety
Description
Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)
Time Frame
Baseline to Week 12
Title
Anxiety
Description
Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)
Time Frame
Baseline to Week 26
Title
Dietary Monitoring
Description
Estimated mean change in number of days recording caloric intake
Time Frame
Baseline to Week 12
Title
Dietary Monitoring
Description
Estimated mean change in number of days recording caloric intake
Time Frame
Baseline to Week 26
Title
Self-Reported Self-Monitoring Behaviors
Description
Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)
Time Frame
Baseline to Week 12
Title
Self-Reported Self-Monitoring Behaviors
Description
Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)
Time Frame
Baseline to Week 26
Title
Weight Bias Internalization
Description
Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Time Frame
Baseline to week 52
Title
Weight Self-Stigma Questionnaire (WSSQ)
Description
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
Time Frame
Baseline to week 52
Title
Weight Bias
Description
Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Time Frame
Baseline to week 52
Title
Depression
Description
Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Time Frame
Baseline to week 52
Title
Perceived Stress
Description
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time Frame
Baseline to week 52
Title
Exercise Self-Efficacy
Description
Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Time Frame
Baseline to week 52
Title
Weight-Related Quality of Life
Description
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)
Time Frame
Baseline to week 52
Title
Eating Self-Efficacy
Description
Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Time Frame
Baseline to week 52
Title
Percent Weight Change
Description
Estimated mean change in percent weight change. Weight measured in kilograms (kg)
Time Frame
Baseline to week 52
Title
Waist Circumference
Description
Estimated mean change in waist circumference (cm)
Time Frame
Baseline to week 52
Title
Blood Pressure
Description
Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.
Time Frame
Baseline to week 52
Title
Body Esteem
Description
Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)
Time Frame
Baseline to Week 52
Title
Coping Behaviors in Response to Weight Stigma
Description
Estimated mean change score on the Coping with Weight Stigma Questionnaire for Full scale and four subscales of Negative Affect, Maladaptive Eating, Healthy Lifestyle, and Exercise Avoidance (scale scoring 0-4 for Full scale and all subscales); higher scores indicate greater endorsement of coping strategies
Time Frame
Baseline to Week 52
Title
Body Dissatisfaction
Description
Estimated mean change score on the Body Areas Satisfaction Subscale of the Multidimensional Body-Self Relations Questionnaire-Appearance Scales (scale scoring 1-5; higher scores indicating greater satisfaction)
Time Frame
Baseline to Week 52
Title
Anxiety
Description
Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)
Time Frame
Baseline to Week 52
Title
Disordered Eating
Description
Estimated mean change score on the Eating Disorders Examination Questionnaire for Global score and four subscales of Eating Restraint, Eating Concern, Weight Concern, and Shape Concern (scale scoring 0-6 for Global score and all subscales; higher scores indicate greater pathology)
Time Frame
Baseline to Week 52
Title
Eating Behaviors
Description
Estimated mean change score on the Eating Inventory Questionnaire for three subscales of Dietary Restraint (summed 0-21), Disinhibition (summed 0-16), and Hunger (summed 0-14); higher values indicate greater restraint/disinhibition/hunger
Time Frame
Baseline to Week 52
Title
Self-Reported Self-Monitoring Behaviors
Description
Estimated mean change in self-reported frequency of tracking of: weight, food/drink, calories, and physical activity; 0-4 rating for each of the four behaviors (higher scores indicate greater self-reported frequency of self-monitoring behavior)
Time Frame
Baseline to Week 52
Title
Treatment Acceptability Ratings
Description
To assess treatment acceptability, participants in both groups 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 new skills or information from each component. Scores for these three items were averaged (1-7) separately for the BWL treatment, BIAS component, and recipe exchange. Higher scores indicate greater treatment acceptability.
Time Frame
Week 26
Title
Treatment Acceptability Ratings
Description
To assess treatment acceptability, participants rated (1-7) 5 items to indicate the extent to which they found the program (as a whole) to be helpful and acceptable, and how much they liked, were satisfied with, and would recommend the program to others. Scores are averaged 1-7, with higher scores indicating greater treatment acceptability.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L Pearl, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Pennsylvania Center for Weight and Eating Disorders
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32860344
Citation
Pearl RL, Wadden TA, Bach C, Tronieri JS, Berkowitz RI. Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program. Obesity (Silver Spring). 2020 Oct;28(10):1878-1888. doi: 10.1002/oby.22931. Epub 2020 Aug 28.
Results Reference
derived

Learn more about this trial

Psychological Intervention to Reduce Weight Bias Internalization

We'll reach out to this number within 24 hrs