CompletedNCT03572218Updated Oct 23, 2020Results posted

Psychological Intervention to Reduce Weight Bias Internalization

An interventional study of BWL and BIAS in Stigmatization, Obesity and Weight Loss, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-10-23.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 72
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Conditions studied

Stigmatization
Obesity
Weight Loss

Browse trials for

In context

Body Weight

1,223 studies on the registry are indexed under Body Weight; 131 are open to participants now.

This study's enrollment of 72 is above the median of 64 across 947 interventional studies indexed under Body Weight.

Browse Body Weight studies →

Lead sponsor

University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 72 participants (actual)

Study arms

Experimental
BWL + BIAS
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 · Behavioral: BIAS
Active comparator
Standard BWL
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

Interventions

BehavioralBWL
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.
BehavioralBIAS
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.

What researchers measure

Primary outcomes

Weight Bias Internalization
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 outcomes

Weight Bias Internalization
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
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to week 26
Perceived Stress
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time frame: Baseline to week 12
Perceived Stress
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline to week 26
Percent Weight Change
Estimated mean change in percent weight change. Weight measured in kilograms (kg).
Time frame: Baseline to week 26
Waist Circumference
Estimated mean change in waist circumference (cm).
Time frame: 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.
Time frame: Baseline to week 26

Other outcomes

Coping Behaviors in Response to Weight Stigma
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
Coping Behaviors in Response to Weight Stigma
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
Body Esteem
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
Body Esteem
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
Body Dissatisfaction
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
Body Dissatisfaction
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
Disordered Eating
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
Disordered Eating
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
Eating Behaviors
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
Eating Behaviors
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
Anxiety
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
Anxiety
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
Dietary Monitoring
Estimated mean change in number of days recording caloric intake
Time frame: Baseline to Week 12
Dietary Monitoring
Estimated mean change in number of days recording caloric intake
Time frame: Baseline to Week 26
Self-Reported Self-Monitoring Behaviors
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
Self-Reported Self-Monitoring Behaviors
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
Weight Bias Internalization
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
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
Time frame: Baseline to week 52
Weight Bias
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
Depression
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
Perceived Stress
Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Time frame: Baseline to week 52
Exercise Self-Efficacy
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
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)
Time frame: Baseline to week 52
Eating Self-Efficacy
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
Percent Weight Change
Estimated mean change in percent weight change. Weight measured in kilograms (kg)
Time frame: Baseline to week 52
Waist Circumference
Estimated mean change in waist circumference (cm)
Time frame: Baseline to week 52
Blood Pressure
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
Body Esteem
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
Coping Behaviors in Response to Weight Stigma
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
Body Dissatisfaction
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
Anxiety
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
Disordered Eating
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
Eating Behaviors
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
Self-Reported Self-Monitoring Behaviors
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
Treatment Acceptability Ratings
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
Treatment Acceptability Ratings
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

Results

Posted Jun 16, 2020

Participant flow

Recruitment began April 2018 and ended October 2018. Participants were recruited by flyers, local media, and physician referrals for a study about weight loss and social experiences related to weight. Participants were screened by telephone and by a subsequent in-person behavioral evaluation and brief medical evaluation.

Participant flow — Overall Study
Milestone	BWL + BIAS	Standard BWL
Started	36	36
Week 12	30	31
Week 26	30	31
Completed	30	31
Not completed	6	5
Withdrew: Lost to follow-up	3	2
Withdrew: No longer available for study visits	2	1
Withdrew: No longer interested	1	2

Outcome measures

PrimaryWeight Bias Internalization

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
Reported as:: Mean · scores on a scale

Weight Bias Internalization
scores on a scale	BWL + BIAS	Standard BWL
Weight Bias Internalization	-1.3 ± 0.2	-1.0 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.22 · Mean difference (net): -0.3

SecondaryWeight Bias Internalization

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
Reported as:: Mean · scores on a scale

Weight Bias Internalization
scores on a scale	BWL + BIAS	Standard BWL
Weight Bias Internalization	-1.5 ± 0.2	-1.3 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.45 · Mean difference (net): -0.2

SecondaryWeight 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

Time frame:: Baseline to week 12
Reported as:: Mean · scores on a scale

Weight Self-Stigma Questionnaire (WSSQ)
scores on a scale	BWL + BIAS	Standard BWL
WSSQ-Total	-6.0 ± 1.4	-1.6 ± 1.3
WSSQ-SD	-3.6 ± 0.8	-1.0 ± 0.8
WSSQ-FNE	-2.3 ± 0.8	-0.7 ± 0.8

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.03 · Mean difference (net): -4.4
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.02 · Mean difference (net): -2.8
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.19 · Mean difference (net): -1.6

SecondaryWeight Self-Stigma Questionnaire (WSSQ)

Time frame:: Baseline to week 26
Reported as:: Mean · scores on a scale

Weight Self-Stigma Questionnaire (WSSQ)
scores on a scale	BWL + BIAS	Standard BWL
WSSQ-Total	-7.1 ± 1.5	-3.6 ± 1.5
WSSQ-SD	-4.1 ± 0.8	-1.5 ± 0.8
WSSQ-FNE	-2.9 ± 0.9	-2.1 ± 0.9

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.11 · Mean difference (net): -3.5
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.03 · Mean difference (net): -2.6
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.53 · Mean difference (net): -0.8

SecondaryWeight Bias

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
Reported as:: Mean · scores on a scale

Weight Bias
scores on a scale	BWL + BIAS	Standard BWL
Weight Bias	-0.5 ± 0.1	-0.2 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.12 · Mean difference (net): -0.3

SecondaryWeight Bias

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
Reported as:: Mean · scores on a scale

Weight Bias
scores on a scale	BWL + BIAS	Standard BWL
Weight Bias	-0.5 ± 0.1	-0.2 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.09 · Mean difference (net): -0.3

SecondaryWeight-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)

Time frame:: Baseline to week 12
Reported as:: Mean · scores on a scale

Weight-Related Quality of Life
scores on a scale	BWL + BIAS	Standard BWL
Total	8.3 ± 2.1	8.9 ± 2.0
Physical Function	9.8 ± 2.9	8.8 ± 2.8
Self Esteem	12.9 ± 3.0	9.2 ± 3.0
Sexual Life	5.5 ± 3.6	9.5 ± 3.5
Work	4.8 ± 3.1	6.9 ± 3.0
Public Distress	5.7 ± 2.6	7.7 ± 2.6

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.84 · Mean difference (net): -0.6
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.82 · Mean difference (net): 0.9
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.39 · Mean difference (net): 3.7
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.42 · Mean difference (net): -4.0
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.64 · Mean difference (net): -2.0
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.59 · Mean difference (net): -2.0

SecondaryWeight-Related Quality of Life

Time frame:: Baseline to week 26
Reported as:: Mean · scores on a scale

Weight-Related Quality of Life
scores on a scale	BWL + BIAS	Standard BWL
Total	12.5 ± 2.1	14.1 ± 2.1
Physical Function	13.7 ± 2.9	14.2 ± 2.8
Self Esteem	19.1 ± 3.4	18.5 ± 3.3
Sexual Life	7.0 ± 3.6	14.0 ± 3.5
Work	8.6 ± 3.1	6.8 ± 3.0
Public Distress	9.9 ± 2.6	11.2 ± 2.6

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.58 · Mean difference (net): -1.7
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.89 · Mean difference (net): -0.5
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.90 · Mean difference (net): 0.6
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.16 · Mean difference (net): -7.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.68 · Mean difference (net): 1.8
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.72 · Mean difference (net): -1.3

SecondaryPerceived Stress

Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

Time frame:: Baseline to week 12
Reported as:: Mean · scores on a scale

Perceived Stress
scores on a scale	BWL + BIAS	Standard BWL
Perceived Stress	-3.2 ± 1.2	-0.1 ± 1.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.08 · Mean difference (net): -3.0

SecondaryPerceived Stress

Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

Time frame:: Baseline to week 26
Reported as:: Mean · scores on a scale

Perceived Stress
scores on a scale	BWL + BIAS	Standard BWL
Perceived Stress	-3.9 ± 1.2	-1.0 ± 1.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.10 · Mean difference (net): -2.9

SecondaryDepression

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
Reported as:: Mean · scores on a scale

Depression
scores on a scale	BWL + BIAS	Standard BWL
Depression	-3.4 ± 0.8	-2.5 ± 0.8

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.40 · Mean difference (net): -0.9

SecondaryDepression

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
Reported as:: Mean · scores on a scale

Depression
scores on a scale	BWL + BIAS	Standard BWL
Depression	-2.9 ± 0.8	-2.9 ± 0.8

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.98 · Mean difference (net): -0.03

SecondaryExercise Self-Efficacy

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
Reported as:: Mean · scores on a scale

Exercise Self-Efficacy
scores on a scale	BWL + BIAS	Standard BWL
Exercise Self-Efficacy	4.0 ± 4.6	-5.7 ± 4.5

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.14 · Mean difference (net): 9.7

SecondaryExercise Self-Efficacy

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
Reported as:: Mean · scores on a scale

Exercise Self-Efficacy
scores on a scale	BWL + BIAS	Standard BWL
Exercise Self-Efficacy	5.8 ± 4.6	-6.3 ± 4.5

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.06 · Mean difference (net): 12.1

SecondaryEating Self-Efficacy

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
Reported as:: Mean · scores on a scale

Eating Self-Efficacy
scores on a scale	BWL + BIAS	Standard BWL
Eating Self-Efficacy	11.3 ± 3.1	10.2 ± 3.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.80 · Mean difference (net): 1.1

SecondaryEating Self-Efficacy

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
Reported as:: Mean · scores on a scale

Eating Self-Efficacy
scores on a scale	BWL + BIAS	Standard BWL
Eating Self-Efficacy	12.0 ± 3.1	8.9 ± 3.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.49 · Mean difference (net): 3.1

SecondaryPercent Weight Change

Estimated mean change in percent weight change. Weight measured in kilograms (kg).

Time frame:: Baseline to week 26
Reported as:: Mean · percent weight change

Percent Weight Change
percent weight change	BWL + BIAS	Standard BWL
Percent Weight Change	-4.5 ± 1.0	-5.9 ± 1.0

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.31 · Mean difference (net): 1.4

SecondaryWaist Circumference

Estimated mean change in waist circumference (cm).

Time frame:: Baseline to week 26
Reported as:: Mean · change in cm

Waist Circumference
change in cm	BWL + BIAS	Standard BWL
Waist Circumference	-4.3 ± 0.9	-5.1 ± 0.9

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.54 · Mean difference (net): 0.8

SecondaryBlood Pressure

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
Reported as:: Mean · change in mmHg

Blood Pressure
change in mmHg	BWL + BIAS	Standard BWL
Systolic Blood Pressure	-2.6 ± 1.6	-2.4 ± 1.6
Diastolic Blood Pressure	-1.5 ± 1.2	-2.2 ± 1.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.94 · Mean difference (net): -0.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.64 · Mean difference (net): 0.8

Other pre-specifiedCoping Behaviors in Response to Weight Stigma

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
Reported as:: Mean · scores on a scale

Coping Behaviors in Response to Weight Stigma
scores on a scale	BWL + BIAS	Standard BWL
Full Scale	-0.7 ± 0.1	-0.8 ± 0.1
Negative Affect	-1.1 ± 0.1	-1.2 ± 0.1
Maladaptive Eating	-0.7 ± 0.1	-0.7 ± 0.1
Healthy Lifestyle	0.0 ± 0.2	0.1 ± 0.2
Exercise Avoidance	-0.8 ± 0.2	-0.5 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.58 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.49 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.96 · Mean difference (net): 0.0
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.71 · Mean difference (net): 0.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.41 · Mean difference (net): -0.3

Other pre-specifiedCoping Behaviors in Response to Weight Stigma

Time frame:: Baseline to week 26
Reported as:: Mean · scores on a scale

Coping Behaviors in Response to Weight Stigma
scores on a scale	BWL + BIAS	Standard BWL
Full Scale	-0.8 ± 0.1	-0.9 ± 0.1
Negative Affect	-1.3 ± 0.2	-1.2 ± 0.2
Maladaptive Eating	-0.8 ± 0.1	-0.8 ± 0.1
Healthy Lifestyle	-0.2 ± 0.2	0.0 ± 0.2
Exercise Avoidance	-0.9 ± 0.2	-0.9 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.61 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.73 · Mean difference (net): -0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.94 · Mean difference (net): 0.0
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.47 · Mean difference (net): -0.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.99 · Mean difference (net): 0.0

Other pre-specifiedBody Esteem

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
Reported as:: Mean · scores on a scale

Body Esteem
scores on a scale	BWL + BIAS	Standard BWL
Body Esteem	0.6 ± 0.1	0.3 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.13 · Mean difference (net): 0.3

Other pre-specifiedBody Esteem

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
Reported as:: Mean · scores on a scale

Body Esteem
scores on a scale	BWL + BIAS	Standard BWL
Body Esteem	0.8 ± 0.1	0.5 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.13 · Mean difference (net): 0.3

Other pre-specifiedBody Dissatisfaction

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
Reported as:: Mean · scores on a scale

Body Dissatisfaction
scores on a scale	BWL + BIAS	Standard BWL
Body Dissatisfaction	0.4 ± 0.1	0.4 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.53 · Mean difference (net): 0.1

Other pre-specifiedBody Dissatisfaction

Time frame:: Baseline to Week 26
Reported as:: Mean · scores on a scale

Body Dissatisfaction
scores on a scale	BWL + BIAS	Standard BWL
Body Dissatisfaction	0.6 ± 0.1	0.5 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.24 · Mean difference (net): 0.2

Other pre-specifiedDisordered Eating

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
Reported as:: Mean · scores on a scale

Disordered Eating
scores on a scale	BWL + BIAS	Standard BWL
Global	-0.2 ± 0.1	-0.2 ± 0.1
Eating Restraint	1.7 ± 0.2	1.5 ± 0.2
Eating Concern	-0.4 ± 0.2	-0.7 ± 0.2
Weight Concern	-0.7 ± 0.2	-0.7 ± 0.2
Shape Concern	-1.1 ± 0.2	-0.9 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.83 · Mean difference (net): 0.0
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.69 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.30 · Mean difference (net): 0.3
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.99 · Mean difference (net): 0.0
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.36 · Mean difference (net): -0.3

Other pre-specifiedDisordered Eating

Time frame:: Baseline to Week 26
Reported as:: Mean · scores on a scale

Disordered Eating
scores on a scale	BWL + BIAS	Standard BWL
Global	-0.5 ± 0.1	-0.3 ± 0.1
Eating Restraint	1.2 ± 0.2	1.0 ± 0.2
Eating Concern	-0.7 ± 0.2	-0.6 ± 0.2
Weight Concern	-1.2 ± 0.2	-0.8 ± 0.2
Shape Concern	-1.4 ± 0.2	-1.0 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.30 · Mean difference (net): -0.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.69 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.70 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.26 · Mean difference (net): -0.4
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.18 · Mean difference (net): -0.4

Other pre-specifiedEating Behaviors

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
Reported as:: Mean · scores on a scale

Eating Behaviors
scores on a scale	BWL + BIAS	Standard BWL
Dietary Restraint	6.3 ± 0.7	5.9 ± 0.7
Disinhibition	-2.8 ± 0.6	-1.9 ± 0.6
Hunger	-3.2 ± 0.5	-1.4 ± 0.5

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.69 · Mean difference (net): 0.4
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.28 · Mean difference (net): 0.9
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.02 · Mean difference (net): -1.8

Other pre-specifiedEating Behaviors

Time frame:: Baseline to Week 26
Reported as:: Mean · scores on a scale

Eating Behaviors
scores on a scale	BWL + BIAS	Standard BWL
Dietary Restraint	6.4 ± 0.8	5.2 ± 0.8
Disinhibition	-3.0 ± 0.6	-2.2 ± 0.6
Hunger	-3.9 ± 0.5	-1.4 ± 0.5

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.29 · Mean difference (net): 1.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.34 · Mean difference (net): -0.8
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.001 · Mean difference (net): -2.5

Other pre-specifiedAnxiety

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
Reported as:: Mean · scores on a scale

Anxiety
scores on a scale	BWL + BIAS	Standard BWL
Anxiety	-1.8 ± 0.8	-0.7 ± 0.8

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.32 · Mean difference (net): -1.1

Other pre-specifiedAnxiety

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
Reported as:: Mean · scores on a scale

Anxiety
scores on a scale	BWL + BIAS	Standard BWL
Anxiety	-1.6 ± 0.8	-0.8 ± 0.8

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.16 · Mean difference (net): -0.8

Other pre-specifiedDietary Monitoring

Estimated mean change in number of days recording caloric intake

Time frame:: Baseline to Week 12
Reported as:: Mean · number of days

Dietary Monitoring
number of days	BWL + BIAS	Standard BWL
Dietary Monitoring	52.9 ± 3.4	55.5 ± 3.4

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.59 · Mean difference (net): 2.6

Other pre-specifiedDietary Monitoring

Estimated mean change in number of days recording caloric intake

Time frame:: Baseline to Week 26
Reported as:: Mean · number of days

Dietary Monitoring
number of days	BWL + BIAS	Standard BWL
Dietary Monitoring	85.6 ± 9.5	95.8 ± 9.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.44 · Mean difference (net): -10.2

Other pre-specifiedSelf-Reported Self-Monitoring Behaviors

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
Reported as:: Mean · scores on a scale

Self-Reported Self-Monitoring Behaviors
scores on a scale	BWL + BIAS	Standard BWL
Self-Reported Weighing	0.9 ± 0.2	1.1 ± 0.2
Track Food/Drink	2.7 ± 0.3	2.0 ± 0.3
Track Calories	2.0 ± 0.3	1.7 ± 0.3
Track Activity	1.6 ± 0.3	0.8 ± 0.3

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.46 · Mean difference (net): -0.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.12 · Mean difference (net): 0.7
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.42 · Mean difference (net): 0.3
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.03 · Mean difference (net): 0.8

Other pre-specifiedSelf-Reported Self-Monitoring Behaviors

Time frame:: Baseline to Week 26
Reported as:: Mean · scores on a scale

Self-Reported Self-Monitoring Behaviors
scores on a scale	BWL + BIAS	Standard BWL
Self-Reported Weighing	1.0 ± 0.2	0.6 ± 0.2
Track Food/Drink	1.6 ± 0.3	1.6 ± 0.3
Track Calories	1.7 ± 0.3	1.4 ± 0.3
Track Activity	1.3 ± 0.3	0.9 ± 0.3

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.23 · Mean difference (net): 0.4
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.90 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.36 · Mean difference (net): 0.3
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.29 · Mean difference (net): 0.5

Other pre-specifiedWeight Bias Internalization

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
Reported as:: Mean · scores on scale

Weight Bias Internalization
scores on scale	BWL + BIAS	Standard BWL
Weight Bias Internalization	-1.5 ± 0.2	-1.2 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.25 · Mean difference (net): -0.3

Other pre-specifiedWeight Self-Stigma Questionnaire (WSSQ)

Time frame:: Baseline to week 52
Reported as:: Mean · scores on scale

Weight Self-Stigma Questionnaire (WSSQ)
scores on scale	BWL + BIAS	Standard BWL
WSSQ-Total	-5.6 ± 1.6	-3.1 ± 1.6
WSSQ-SD	-2.9 ± 0.8	-1.2 ± 0.8
WSSQ-FNE	-2.7 ± 1.0	-2.0 ± 1.0

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.27 · Mean difference (net): -2.5
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.13 · Mean difference (net): -1.8
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.65 · Mean difference (net): 0.6

Other pre-specifiedWeight Bias

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
Reported as:: Mean · scores on scale

Weight Bias
scores on scale	BWL + BIAS	Standard BWL
Weight Bias	-0.4 ± 0.1	-0.2 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.21 · Mean difference (net): -0.2

Other pre-specifiedDepression

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
Reported as:: Mean · scores on scale

Depression
scores on scale	BWL + BIAS	Standard BWL
Depression	-2.9 ± 0.9	-2.4 ± 0.9

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.7 · Mean difference (net): -0.5

Other pre-specifiedPerceived Stress

Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)

Time frame:: Baseline to week 52
Reported as:: Mean · scores on scale

Perceived Stress
scores on scale	BWL + BIAS	Standard BWL
Perceived Stress	-2.4 ± 1.3	-0.1 ± 1.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.2 · Mean difference (net): -2.3

Other pre-specifiedExercise Self-Efficacy

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
Reported as:: Mean · scores on a scale

Exercise Self-Efficacy
scores on a scale	BWL + BIAS	Standard BWL
Exercise Self-Efficacy	-3.1 ± 4.9	-6.8 ± 4.8

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.59 · Mean difference (net): 3.7

Other pre-specifiedWeight-Related Quality of Life

Time frame:: Baseline to week 52
Reported as:: Mean · scores on scale

Weight-Related Quality of Life
scores on scale	BWL + BIAS	Standard BWL
Total	14.3 ± 2.5	13.4 ± 2.5
Physical Function	12.4 ± 3.1	13.2 ± 3.1
Self Esteem	20.0 ± 3.9	17.7 ± 3.9
Sexual Life	13.3 ± 3.7	11.6 ± 3.6
Work	12.1 ± 3.1	11.8 ± 3.1
Public Distress	12.6 ± 2.7	7.6 ± 2.7

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.81 · Mean difference (net): 0.9
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.86 · Mean difference (net): 0.8
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.87 · Mean difference (net): 1.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.73 · Mean difference (net): 1.8
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.95 · Mean difference (net): 0.3
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.19 · Mean difference (net): 5.0

Other pre-specifiedEating Self-Efficacy

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
Reported as:: Mean · scores on scale

Eating Self-Efficacy
scores on scale	BWL + BIAS	Standard BWL
Eating Self-Efficacy	8.3 ± 3.4	1.0 ± 3.4

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.14 · Mean difference (net): 7.3

Other pre-specifiedPercent Weight Change

Estimated mean change in percent weight change. Weight measured in kilograms (kg)

Time frame:: Baseline to week 52
Reported as:: Mean · percent weight change

Percent Weight Change
percent weight change	BWL + BIAS	Standard BWL
Percent Weight Change	-3.1 ± 1.0	-4.0 ± 1.0

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.53 · Mean difference (net): 0.9

Other pre-specifiedWaist Circumference

Estimated mean change in waist circumference (cm)

Time frame:: Baseline to week 52
Reported as:: Mean · change in cm

Waist Circumference
change in cm	BWL + BIAS	Standard BWL
Waist Circumference	-4.4 ± 1.0	-4.4 ± 1.0

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.99 · Mean difference (net): 0.0

Other pre-specifiedBlood Pressure

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
Reported as:: Mean · change in mmHg

Blood Pressure
change in mmHg	BWL + BIAS	Standard BWL
Systolic Blood Pressure	-5.7 ± 2.5	-4.3 ± 2.5
Diastolic Blood Pressure	-1.1 ± 1.3	-1.8 ± 1.3

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.71 · Mean difference (net): -1.4
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.72 · Mean difference (net): 0.7

Other pre-specifiedBody Esteem

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
Reported as:: Mean · scores on a scale

Body Esteem
scores on a scale	BWL + BIAS	Standard BWL
Body Esteem	0.8 ± 0.1	0.4 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.07 · Mean difference (net): 0.4

Other pre-specifiedCoping Behaviors in Response to Weight Stigma

Time frame:: Baseline to Week 52
Reported as:: Mean · scores on a scale

Coping Behaviors in Response to Weight Stigma
scores on a scale	BWL + BIAS	Standard BWL
Full Scale	-0.7 ± 0.1	-0.6 ± 0.1
Negative Affect	-1.2 ± 0.1	-0.8 ± 0.1
Maladaptive Eating	-0.6 ± 0.1	-0.6 ± 0.1
Exercise Avoidance	-0.7 ± 0.3	-0.6 ± 0.3
Healthy Lifestyle	-0.2 ± 0.2	0.0 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.52 · Mean difference (net): -0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.02 · Mean difference (net): -0.5
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.63 · Mean difference (net): -0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.74 · Mean difference (net): -0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.49 · Mean difference (net): -0.2

Other pre-specifiedBody Dissatisfaction

Time frame:: Baseline to Week 52
Reported as:: Mean · scores on a scale

Body Dissatisfaction
scores on a scale	BWL + BIAS	Standard BWL
Body Dissatisfaction	0.5 ± 0.1	0.4 ± 0.1

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.33 · Mean difference (net): 0.2

Other pre-specifiedAnxiety

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
Reported as:: Mean · scores on a scale

Anxiety
scores on a scale	BWL + BIAS	Standard BWL
Anxiety	-1.5 ± 0.9	-0.3 ± 0.9

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.11 · Mean difference (net): -1.2

Other pre-specifiedDisordered Eating

Time frame:: Baseline to Week 52
Reported as:: Mean · scores on a scale

Disordered Eating
scores on a scale	BWL + BIAS	Standard BWL
Global	-0.4 ± 0.1	-0.2 ± 0.1
Eating Restraint	1.0 ± 0.3	0.7 ± 0.3
Eating Concern	-0.6 ± 0.2	-0.3 ± 0.2
Weight Concern	-1.0 ± 0.2	-0.7 ± 0.2
Shape Concern	-1.1 ± 0.2	-0.7 ± 0.2

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.35 · Mean difference (net): -0.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.46 · Mean difference (net): 0.3
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.33 · Mean difference (net): -0.3
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.18 · Mean difference (net): -0.4
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.16 · Mean difference (net): -0.5

Other pre-specifiedEating Behaviors

Time frame:: Baseline to Week 52
Reported as:: Mean · scores on a scale

Eating Behaviors
scores on a scale	BWL + BIAS	Standard BWL
Dietary Restraint	3.5 ± 0.9	3.2 ± 0.9
Disinhibition	-1.8 ± 0.5	-1.2 ± 0.6
Hunger	-2.9 ± 0.6	-0.7 ± 0.6

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.82 · Mean difference (net): 0.3
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.45 · Mean difference (net): -0.6
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.007 · Mean difference (net): -2.2

Other pre-specifiedSelf-Reported Self-Monitoring Behaviors

Time frame:: Baseline to Week 52
Reported as:: Mean · scores on a scale

Self-Reported Self-Monitoring Behaviors
scores on a scale	BWL + BIAS	Standard BWL
Self-Reported Weighing	0.9 ± 0.2	0.5 ± 0.2
Track Food/Drink	0.8 ± 0.2	0.7 ± 0.2
Track Calories	1.2 ± 0.3	1.3 ± 0.3
Track Activity	0.8 ± 0.3	0.3 ± 0.3

Statistical analysis

BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.23 · Mean difference (net): 0.4
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.48 · Mean difference (net): 0.1
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.89 · Mean difference (net): -0.2
BWL + BIAS vs Standard BWL · Mixed Models Analysis · p = 0.30 · Mean difference (net): 0.4

Other pre-specifiedTreatment Acceptability Ratings

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
Reported as:: Mean · scores on a scale

Treatment Acceptability Ratings
scores on a scale	BWL + BIAS	Standard BWL
BWL component	6.5 ± 0.9	6.3 ± 1.0
BIAS component	6.3 ± 1.0	—
Recipe exchange	—	5.4 ± 1.5

Statistical analysis

BWL + BIAS vs Standard BWL · ANOVA · p = 0.32

Other pre-specifiedTreatment Acceptability Ratings

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
Reported as:: Mean · scores on a scale

Treatment Acceptability Ratings
scores on a scale	BWL + BIAS	Standard BWL
Treatment Acceptability Ratings	6.5 ± 0.6	6.2 ± 0.9

Statistical analysis

BWL + BIAS vs Standard BWL · ANOVA · p = 0.14

Adverse events

Collected over Week 1 through week 26. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BWL + BIAS	0/36 (0%)	0/36 (0%)	3/36 (8.3%)
Standard BWL	0/36 (0%)	1/36 (2.8%)	7/36 (19.4%)

Most frequent serious events

Most frequent serious events
Event	BWL + BIAS	Standard BWL
HypokalemiaRenal and urinary disorders	0/36	1/36

Most frequent other events

Most frequent other events
Event	BWL + BIAS	Standard BWL
Viral gastroenteritisGastrointestinal disorders	1/36	3/36
Asthma exacerbationRespiratory, thoracic and mediastinal disorders	2/36	0/36
Back painMusculoskeletal and connective tissue disorders	0/36	2/36
Knee painMusculoskeletal and connective tissue disorders	0/36	2/36

Baseline characteristics

Age, Continuous
Age, Continuous(years)	BWL + BIAS	Standard BWL	Total
Mean	47.7 ± 11.4	46.6 ± 11.8	47.1 ± 11.5

Sex: Female, Male
Sex: Female, Male(Participants)	BWL + BIAS	Standard BWL	Total
Female	32	29	61
Male	4	7	11

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	BWL + BIAS	Standard BWL	Total
Hispanic or Latino	4	2	6
Not Hispanic or Latino	32	34	66
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	BWL + BIAS	Standard BWL	Total
American Indian or Alaska Native	0	0	0
Asian	2	0	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	26	22	48
White	7	14	21
More than one race	1	0	1
Unknown or Not Reported	0	0	0

Weight
Weight(kilograms)	BWL + BIAS	Standard BWL	Total
Mean	112.4 ± 24.0	107.2 ± 21.2	109.8 ± 22.6

Height
Height(centimeters)	BWL + BIAS	Standard BWL	Total
Mean	167.0 ± 8.7	166.6 ± 8.5	166.8 ± 8.5

Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)	BWL + BIAS	Standard BWL	Total
Mean	40.1 ± 6.5	38.4 ± 5.6	39.3 ± 6.1

Waist Circumference
Waist Circumference(centimeters)	BWL + BIAS	Standard BWL	Total
Mean	119.1 ± 15.3	114.9 ± 12.6	117.0 ± 14.1

13 further baseline measures are reported on the registry.

Study locations

1 site

The University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania 19104, United States

References and documents

Publications

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. PubMed 32860344 ↗

Study documents

Protocol and statistical analysis plan · Mar 1, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03572218
Lead sponsor: University of Pennsylvania
Collaborators: WW International Inc
Responsible party: Rebecca L. Pearl, Ph.D. (Assistant Professor, University of Pennsylvania) — Principal investigator
First posted: Jun 28, 2018
Start date: Apr 10, 2018
Primary completion: Apr 9, 2019
Completion: Oct 18, 2019
Results posted: Jun 16, 2020
Last update: Oct 23, 2020

Study contacts

Rebecca L Pearl, PhD

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Body Weight→

Other studies from this sponsor

University of Pennsylvania

Start the discussion

Psychological Intervention to Reduce Weight Bias Internalization

Study summary

Conditions studied

Browse trials for

In context

Body Weight

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Other outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Study documents

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria