Skip to content

Psychological Intervention to Reduce Weight Bias Internalization

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572218
Enrollment
72
Registered
2018-06-28
Start date
2018-04-10
Completion date
2019-10-18
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stigmatization, Obesity, Weight Loss

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.

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.

Sponsors

WW International Inc
CollaboratorINDUSTRY
University of Pennsylvania
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

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.

Design outcomes

Primary

MeasureTime frameDescription
Weight Bias InternalizationBaseline to week 12Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)

Secondary

MeasureTime frameDescription
Weight Self-Stigma Questionnaire (WSSQ)Baseline to week 12Estimated 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 BiasBaseline to week 12Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
Weight-Related Quality of LifeBaseline to week 12Estimated 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 StressBaseline to week 12Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
DepressionBaseline to week 12Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)
Weight Bias InternalizationBaseline to week 26Estimated mean change score on the Weight Bias Internalization Scale (scale scoring 1-7; higher scores indicate greater weight bias internalization)
Eating Self-EfficacyBaseline to week 12Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Percent Weight ChangeBaseline to week 26Estimated mean change in percent weight change. Weight measured in kilograms (kg).
Waist CircumferenceBaseline to week 26Estimated mean change in waist circumference (cm).
Blood PressureBaseline to week 26Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.
Exercise Self-EfficacyBaseline to week 12Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)

Other

MeasureTime frameDescription
Perceived StressBaseline to week 52Estimated mean change score on the Perceived Stress Scale (summed 0-40; higher scores indicate greater perceived stress)
Exercise Self-EfficacyBaseline to week 52Estimated mean change score on the Self-Efficacy for Exercise Scale (summed 0-90; higher scores indicate greater self-efficacy)
Weight-Related Quality of LifeBaseline to week 52Estimated 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)
Eating Self-EfficacyBaseline to week 52Estimated mean change score on the Weight and Lifestyle Efficacy - Short Form (summed 0-80; higher scores indicate greater self-efficacy)
Coping Behaviors in Response to Weight StigmaBaseline to week 12Estimated 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
Waist CircumferenceBaseline to week 52Estimated mean change in waist circumference (cm)
Blood PressureBaseline to week 52Estimated mean change in blood pressure (systolic blood pressure and diastolic blood pressure; mmHg), controlling for blood pressure medication.
Treatment Acceptability RatingsWeek 26To 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.
Percent Weight ChangeBaseline to week 52Estimated mean change in percent weight change. Weight measured in kilograms (kg)
Body EsteemBaseline to Week 12Estimated mean change score on the Body Appreciation Scale (scale scoring 1-5; higher scores indicate greater body appreciation)
Body DissatisfactionBaseline to Week 12Estimated 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)
Disordered EatingBaseline to Week 12Estimated 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)
Eating BehaviorsBaseline to Week 12Estimated 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
AnxietyBaseline to Week 12Estimated mean change score on the Generalized Anxiety Disorder-7 Questionnaire (summed 0-21; higher scores indicate greater anxiety)
Dietary MonitoringBaseline to Week 12Estimated mean change in number of days recording caloric intake
Self-Reported Self-Monitoring BehaviorsBaseline to Week 12Estimated 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)
Weight Bias InternalizationBaseline to week 52Estimated 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)Baseline to week 52Estimated 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 BiasBaseline to week 52Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)
DepressionBaseline to week 52Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
BWL + BIAS
In the behavioral weight loss (BWL) + weight bias internalization and stigma (BIAS) group, participants received 60-minute BWL sessions followed by 30 minutes of a weight stigma-reduction intervention. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
36
Standard BWL
In the BWL group, participants received 60-minute BWL sessions followed by 30 minutes devoted to discussing recipes and food preparation. Participants received weekly group treatment sessions for 12 weeks, followed by every-other-week and monthly sessions from weeks 13-26.
36
Total72

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up32
Overall StudyNo longer available for study visits21
Overall StudyNo longer interested12

Baseline characteristics

CharacteristicTotalBWL + BIASStandard BWL
Age, Continuous47.1 years
STANDARD_DEVIATION 11.5
47.7 years
STANDARD_DEVIATION 11.4
46.6 years
STANDARD_DEVIATION 11.8
Anxiety5.4 scores on a scale
STANDARD_DEVIATION 4.3
5.6 scores on a scale
STANDARD_DEVIATION 4.5
5.2 scores on a scale
STANDARD_DEVIATION 4.2
Blood Pressure
Diastolic Blood Pressure
73.7 mmHg
STANDARD_DEVIATION 8.5
73.0 mmHg
STANDARD_DEVIATION 9.2
74.3 mmHg
STANDARD_DEVIATION 7.9
Blood Pressure
Systolic Blood Pressure
127.7 mmHg
STANDARD_DEVIATION 10.3
127.4 mmHg
STANDARD_DEVIATION 10.2
128.0 mmHg
STANDARD_DEVIATION 10.7
Body Esteem2.6 scores on a scale
STANDARD_DEVIATION 0.7
2.8 scores on a scale
STANDARD_DEVIATION 0.6
2.5 scores on a scale
STANDARD_DEVIATION 0.7
Body Mass Index (BMI)39.3 kg/m^2
STANDARD_DEVIATION 6.1
40.1 kg/m^2
STANDARD_DEVIATION 6.5
38.4 kg/m^2
STANDARD_DEVIATION 5.6
Depression8.0 scores on a scale
STANDARD_DEVIATION 4.8
7.5 scores on a scale
STANDARD_DEVIATION 5.1
8.4 scores on a scale
STANDARD_DEVIATION 4.5
Eating Behaviors
Dietary Restraint
8.7 scores on a scale
STANDARD_DEVIATION 3.7
8.5 scores on a scale
STANDARD_DEVIATION 3.7
8.9 scores on a scale
STANDARD_DEVIATION 3.8
Eating Behaviors
Disinhibition
9.7 scores on a scale
STANDARD_DEVIATION 3.3
9.2 scores on a scale
STANDARD_DEVIATION 3.5
10.2 scores on a scale
STANDARD_DEVIATION 3.1
Eating Behaviors
Hunger
7.1 scores on a scale
STANDARD_DEVIATION 3.7
7.8 scores on a scale
STANDARD_DEVIATION 3.6
6.4 scores on a scale
STANDARD_DEVIATION 3.6
Eating Self-Efficacy40.0 scores on a scale
STANDARD_DEVIATION 17.5
39.4 scores on a scale
STANDARD_DEVIATION 17.4
40.7 scores on a scale
STANDARD_DEVIATION 17.9
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants4 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
66 Participants32 Participants34 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Exercise Self-Efficacy51.2 scores on a scale
STANDARD_DEVIATION 20
48.3 scores on a scale
STANDARD_DEVIATION 20.1
54.2 scores on a scale
STANDARD_DEVIATION 19.9
Height166.8 centimeters
STANDARD_DEVIATION 8.5
167.0 centimeters
STANDARD_DEVIATION 8.7
166.6 centimeters
STANDARD_DEVIATION 8.5
Perceived Stress17.3 scores on a scale
STANDARD_DEVIATION 6.4
17.6 scores on a scale
STANDARD_DEVIATION 6.2
16.9 scores on a scale
STANDARD_DEVIATION 6.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
48 Participants26 Participants22 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
21 Participants7 Participants14 Participants
Self-Reported Self-Monitoring Behaviors
Self-Reported Weighing
0.9 scores on a scale
STANDARD_DEVIATION 1.2
0.9 scores on a scale
STANDARD_DEVIATION 1.2
0.9 scores on a scale
STANDARD_DEVIATION 1.1
Self-Reported Self-Monitoring Behaviors
Track Activity
1.2 scores on a scale
STANDARD_DEVIATION 1.5
1.0 scores on a scale
STANDARD_DEVIATION 1.5
1.3 scores on a scale
STANDARD_DEVIATION 1.5
Self-Reported Self-Monitoring Behaviors
Track Calories
0.5 scores on a scale
STANDARD_DEVIATION 1
0.4 scores on a scale
STANDARD_DEVIATION 1
0.6 scores on a scale
STANDARD_DEVIATION 1.1
Self-Reported Self-Monitoring Behaviors
Track Food/Drink
0.5 scores on a scale
STANDARD_DEVIATION 0.8
0.4 scores on a scale
STANDARD_DEVIATION 0.7
0.5 scores on a scale
STANDARD_DEVIATION 0.8
Sex: Female, Male
Female
61 Participants32 Participants29 Participants
Sex: Female, Male
Male
11 Participants4 Participants7 Participants
Waist Circumference117.0 centimeters
STANDARD_DEVIATION 14.1
119.1 centimeters
STANDARD_DEVIATION 15.3
114.9 centimeters
STANDARD_DEVIATION 12.6
Weight109.8 kilograms
STANDARD_DEVIATION 22.6
112.4 kilograms
STANDARD_DEVIATION 24
107.2 kilograms
STANDARD_DEVIATION 21.2
Weight Bias3.7 scores on a scale
STANDARD_DEVIATION 0.6
3.7 scores on a scale
STANDARD_DEVIATION 0.7
3.7 scores on a scale
STANDARD_DEVIATION 0.6
Weight Bias Internalization5.1 scores on a scale
STANDARD_DEVIATION 0.7
5.0 scores on a scale
STANDARD_DEVIATION 0.7
5.2 scores on a scale
STANDARD_DEVIATION 0.7
Weight-Related Quality of Life55.3 scores on a scale
STANDARD_DEVIATION 16.5
56.3 scores on a scale
STANDARD_DEVIATION 16.7
54.2 scores on a scale
STANDARD_DEVIATION 16.5
Weight Self-Stigma Questionnaire (WSSQ)
WSSQ-FNE
19.4 scores on a scale
STANDARD_DEVIATION 4.7
18.8 scores on a scale
STANDARD_DEVIATION 4.6
20.1 scores on a scale
STANDARD_DEVIATION 4.8
Weight Self-Stigma Questionnaire (WSSQ)
WSSQ-SD
19.2 scores on a scale
STANDARD_DEVIATION 4.1
19.1 scores on a scale
STANDARD_DEVIATION 4.2
19.2 scores on a scale
STANDARD_DEVIATION 3.9
Weight Self-Stigma Questionnaire (WSSQ)
WSSQ-Total
38.6 scores on a scale
STANDARD_DEVIATION 6.7
37.9 scores on a scale
STANDARD_DEVIATION 6.6
39.3 scores on a scale
STANDARD_DEVIATION 6.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 360 / 36
other
Total, other adverse events
3 / 367 / 36
serious
Total, serious adverse events
0 / 361 / 36

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWeight Bias Internalization-1.3 scores on a scaleStandard Error 0.2
Standard BWLWeight Bias Internalization-1.0 scores on a scaleStandard Error 0.2
p-value: 0.22Mixed Models Analysis
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASBlood PressureSystolic Blood Pressure-2.6 change in mmHgStandard Error 1.6
BWL + BIASBlood PressureDiastolic Blood Pressure-1.5 change in mmHgStandard Error 1.2
Standard BWLBlood PressureSystolic Blood Pressure-2.4 change in mmHgStandard Error 1.6
Standard BWLBlood PressureDiastolic Blood Pressure-2.2 change in mmHgStandard Error 1.1
Comparison: Systolic Blood Pressurep-value: 0.94Mixed Models Analysis
Comparison: Diastolic Blood Pressurep-value: 0.64Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASDepression-3.4 scores on a scaleStandard Error 0.8
Standard BWLDepression-2.5 scores on a scaleStandard Error 0.8
p-value: 0.4Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASDepression-2.9 scores on a scaleStandard Error 0.8
Standard BWLDepression-2.9 scores on a scaleStandard Error 0.8
p-value: 0.98Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASEating Self-Efficacy11.3 scores on a scaleStandard Error 3.1
Standard BWLEating Self-Efficacy10.2 scores on a scaleStandard Error 3.1
p-value: 0.8Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASEating Self-Efficacy12.0 scores on a scaleStandard Error 3.1
Standard BWLEating Self-Efficacy8.9 scores on a scaleStandard Error 3.1
p-value: 0.49Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASExercise Self-Efficacy5.8 scores on a scaleStandard Error 4.6
Standard BWLExercise Self-Efficacy-6.3 scores on a scaleStandard Error 4.5
p-value: 0.06Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASExercise Self-Efficacy4.0 scores on a scaleStandard Error 4.6
Standard BWLExercise Self-Efficacy-5.7 scores on a scaleStandard Error 4.5
p-value: 0.14Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASPerceived Stress-3.2 scores on a scaleStandard Error 1.2
Standard BWLPerceived Stress-0.1 scores on a scaleStandard Error 1.2
p-value: 0.08Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASPerceived Stress-3.9 scores on a scaleStandard Error 1.2
Standard BWLPerceived Stress-1.0 scores on a scaleStandard Error 1.2
p-value: 0.1Mixed Models Analysis
Secondary

Percent Weight Change

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

Time frame: Baseline to week 26

ArmMeasureValue (MEAN)Dispersion
BWL + BIASPercent Weight Change-4.5 percent weight changeStandard Error 1
Standard BWLPercent Weight Change-5.9 percent weight changeStandard Error 1
p-value: 0.31Mixed Models Analysis
Secondary

Waist Circumference

Estimated mean change in waist circumference (cm).

Time frame: Baseline to week 26

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWaist Circumference-4.3 change in cmStandard Error 0.9
Standard BWLWaist Circumference-5.1 change in cmStandard Error 0.9
p-value: 0.54Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWeight Bias-0.5 scores on a scaleStandard Error 0.1
Standard BWLWeight Bias-0.2 scores on a scaleStandard Error 0.1
p-value: 0.09Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWeight Bias-0.5 scores on a scaleStandard Error 0.1
Standard BWLWeight Bias-0.2 scores on a scaleStandard Error 0.1
p-value: 0.12Mixed Models Analysis
Secondary

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWeight Bias Internalization-1.5 scores on a scaleStandard Error 0.2
Standard BWLWeight Bias Internalization-1.3 scores on a scaleStandard Error 0.2
p-value: 0.45Mixed Models Analysis
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASWeight-Related Quality of LifePhysical Function13.7 scores on a scaleStandard Error 2.9
BWL + BIASWeight-Related Quality of LifeSelf Esteem19.1 scores on a scaleStandard Error 3.4
BWL + BIASWeight-Related Quality of LifeTotal12.5 scores on a scaleStandard Error 2.1
BWL + BIASWeight-Related Quality of LifeSexual Life7.0 scores on a scaleStandard Error 3.6
BWL + BIASWeight-Related Quality of LifeWork8.6 scores on a scaleStandard Error 3.1
BWL + BIASWeight-Related Quality of LifePublic Distress9.9 scores on a scaleStandard Error 2.6
Standard BWLWeight-Related Quality of LifeWork6.8 scores on a scaleStandard Error 3
Standard BWLWeight-Related Quality of LifePhysical Function14.2 scores on a scaleStandard Error 2.8
Standard BWLWeight-Related Quality of LifeSexual Life14.0 scores on a scaleStandard Error 3.5
Standard BWLWeight-Related Quality of LifePublic Distress11.2 scores on a scaleStandard Error 2.6
Standard BWLWeight-Related Quality of LifeTotal14.1 scores on a scaleStandard Error 2.1
Standard BWLWeight-Related Quality of LifeSelf Esteem18.5 scores on a scaleStandard Error 3.3
Comparison: Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total scorep-value: 0.58Mixed Models Analysis
Comparison: Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.89Mixed Models Analysis
Comparison: Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.9Mixed Models Analysis
Comparison: Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.16Mixed Models Analysis
Comparison: Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.68Mixed Models Analysis
Comparison: Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.72Mixed Models Analysis
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASWeight-Related Quality of LifeWork4.8 scores on a scaleStandard Error 3.1
BWL + BIASWeight-Related Quality of LifeTotal8.3 scores on a scaleStandard Error 2.1
BWL + BIASWeight-Related Quality of LifePhysical Function9.8 scores on a scaleStandard Error 2.9
BWL + BIASWeight-Related Quality of LifeSelf Esteem12.9 scores on a scaleStandard Error 3
BWL + BIASWeight-Related Quality of LifeSexual Life5.5 scores on a scaleStandard Error 3.6
BWL + BIASWeight-Related Quality of LifePublic Distress5.7 scores on a scaleStandard Error 2.6
Standard BWLWeight-Related Quality of LifePhysical Function8.8 scores on a scaleStandard Error 2.8
Standard BWLWeight-Related Quality of LifeWork6.9 scores on a scaleStandard Error 3
Standard BWLWeight-Related Quality of LifePublic Distress7.7 scores on a scaleStandard Error 2.6
Standard BWLWeight-Related Quality of LifeSexual Life9.5 scores on a scaleStandard Error 3.5
Standard BWLWeight-Related Quality of LifeTotal8.9 scores on a scaleStandard Error 2
Standard BWLWeight-Related Quality of LifeSelf Esteem9.2 scores on a scaleStandard Error 3
Comparison: Estimated mean change score on the Impact of Weight on Quality of Life Questionnaire-Lite for Total scorep-value: 0.84Mixed Models Analysis
Comparison: Estimated mean change score on the Physical Function Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.82Mixed Models Analysis
Comparison: Estimated mean change score on the Self Esteem Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.39Mixed Models Analysis
Comparison: Estimated mean change score on the Sexual Life Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.42Mixed Models Analysis
Comparison: Estimated mean change score on the Work Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.64Mixed Models Analysis
Comparison: Estimated mean change score on the Public Distress Subscale of the Impact of Weight on Quality of Life Questionnaire-Litep-value: 0.59Mixed Models Analysis
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-FNE-2.9 scores on a scaleStandard Error 0.9
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-Total-7.1 scores on a scaleStandard Error 1.5
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-SD-4.1 scores on a scaleStandard Error 0.8
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-FNE-2.1 scores on a scaleStandard Error 0.9
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-Total-3.6 scores on a scaleStandard Error 1.5
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-SD-1.5 scores on a scaleStandard Error 0.8
Comparison: WSSQ-Totalp-value: 0.11Mixed Models Analysis
Comparison: WSSQ-SDp-value: 0.03Mixed Models Analysis
Comparison: WSSQ-FNEp-value: 0.53Mixed Models Analysis
Secondary

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-SD-3.6 scores on a scaleStandard Error 0.8
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-Total-6.0 scores on a scaleStandard Error 1.4
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-FNE-2.3 scores on a scaleStandard Error 0.8
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-SD-1.0 scores on a scaleStandard Error 0.8
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-Total-1.6 scores on a scaleStandard Error 1.3
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-FNE-0.7 scores on a scaleStandard Error 0.8
Comparison: WSSQ-Totalp-value: 0.03Mixed Models Analysis
Comparison: WSSQ-SDp-value: 0.02Mixed Models Analysis
Comparison: WSSQ-FNEp-value: 0.19Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASAnxiety-1.6 scores on a scaleStandard Error 0.8
Standard BWLAnxiety-0.8 scores on a scaleStandard Error 0.8
p-value: 0.16Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASAnxiety-1.8 scores on a scaleStandard Error 0.8
Standard BWLAnxiety-0.7 scores on a scaleStandard Error 0.8
p-value: 0.32Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASAnxiety-1.5 scores on a scaleStandard Error 0.9
Standard BWLAnxiety-0.3 scores on a scaleStandard Error 0.9
p-value: 0.11Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASBlood PressureSystolic Blood Pressure-5.7 change in mmHgStandard Error 2.5
BWL + BIASBlood PressureDiastolic Blood Pressure-1.1 change in mmHgStandard Error 1.3
Standard BWLBlood PressureSystolic Blood Pressure-4.3 change in mmHgStandard Error 2.5
Standard BWLBlood PressureDiastolic Blood Pressure-1.8 change in mmHgStandard Error 1.3
Comparison: Systolic Blood Pressurep-value: 0.71Mixed Models Analysis
Comparison: Diastolic Blood Pressurep-value: 0.72Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASBody Dissatisfaction0.6 scores on a scaleStandard Error 0.1
Standard BWLBody Dissatisfaction0.5 scores on a scaleStandard Error 0.1
p-value: 0.24Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASBody Dissatisfaction0.4 scores on a scaleStandard Error 0.1
Standard BWLBody Dissatisfaction0.4 scores on a scaleStandard Error 0.1
p-value: 0.53Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASBody Dissatisfaction0.5 scores on a scaleStandard Error 0.1
Standard BWLBody Dissatisfaction0.4 scores on a scaleStandard Error 0.1
p-value: 0.33Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASBody Esteem0.8 scores on a scaleStandard Error 0.1
Standard BWLBody Esteem0.4 scores on a scaleStandard Error 0.1
p-value: 0.07Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASBody Esteem0.6 scores on a scaleStandard Error 0.1
Standard BWLBody Esteem0.3 scores on a scaleStandard Error 0.1
p-value: 0.13Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASBody Esteem0.8 scores on a scaleStandard Error 0.1
Standard BWLBody Esteem0.5 scores on a scaleStandard Error 0.1
p-value: 0.13Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASCoping Behaviors in Response to Weight StigmaNegative Affect-1.1 scores on a scaleStandard Error 0.1
BWL + BIASCoping Behaviors in Response to Weight StigmaHealthy Lifestyle0.0 scores on a scaleStandard Error 0.2
BWL + BIASCoping Behaviors in Response to Weight StigmaMaladaptive Eating-0.7 scores on a scaleStandard Error 0.1
BWL + BIASCoping Behaviors in Response to Weight StigmaExercise Avoidance-0.8 scores on a scaleStandard Error 0.2
BWL + BIASCoping Behaviors in Response to Weight StigmaFull Scale-0.7 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaExercise Avoidance-0.5 scores on a scaleStandard Error 0.2
Standard BWLCoping Behaviors in Response to Weight StigmaFull Scale-0.8 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaNegative Affect-1.2 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaMaladaptive Eating-0.7 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaHealthy Lifestyle0.1 scores on a scaleStandard Error 0.2
Comparison: Full Scalep-value: 0.58Mixed Models Analysis
Comparison: Negative Affectp-value: 0.49Mixed Models Analysis
Comparison: Maladaptive Eatingp-value: 0.96Mixed Models Analysis
Comparison: Healthy Lifestylep-value: 0.71Mixed Models Analysis
Comparison: Exercise Avoidancep-value: 0.41Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASCoping Behaviors in Response to Weight StigmaNegative Affect-1.2 scores on a scaleStandard Error 0.1
BWL + BIASCoping Behaviors in Response to Weight StigmaMaladaptive Eating-0.6 scores on a scaleStandard Error 0.1
BWL + BIASCoping Behaviors in Response to Weight StigmaExercise Avoidance-0.7 scores on a scaleStandard Error 0.3
BWL + BIASCoping Behaviors in Response to Weight StigmaFull Scale-0.7 scores on a scaleStandard Error 0.1
BWL + BIASCoping Behaviors in Response to Weight StigmaHealthy Lifestyle-0.2 scores on a scaleStandard Error 0.2
Standard BWLCoping Behaviors in Response to Weight StigmaHealthy Lifestyle0.0 scores on a scaleStandard Error 0.2
Standard BWLCoping Behaviors in Response to Weight StigmaNegative Affect-0.8 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaFull Scale-0.6 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaMaladaptive Eating-0.6 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaExercise Avoidance-0.6 scores on a scaleStandard Error 0.3
Comparison: Full Scalep-value: 0.52Mixed Models Analysis
Comparison: Negative Affectp-value: 0.02Mixed Models Analysis
Comparison: Maladaptive Eatingp-value: 0.63Mixed Models Analysis
Comparison: Exercise Avoidancep-value: 0.74Mixed Models Analysis
Comparison: Healthy Lifestylep-value: 0.49Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASCoping Behaviors in Response to Weight StigmaNegative Affect-1.3 scores on a scaleStandard Error 0.2
BWL + BIASCoping Behaviors in Response to Weight StigmaHealthy Lifestyle-0.2 scores on a scaleStandard Error 0.2
BWL + BIASCoping Behaviors in Response to Weight StigmaMaladaptive Eating-0.8 scores on a scaleStandard Error 0.1
BWL + BIASCoping Behaviors in Response to Weight StigmaExercise Avoidance-0.9 scores on a scaleStandard Error 0.2
BWL + BIASCoping Behaviors in Response to Weight StigmaFull Scale-0.8 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaExercise Avoidance-0.9 scores on a scaleStandard Error 0.2
Standard BWLCoping Behaviors in Response to Weight StigmaNegative Affect-1.2 scores on a scaleStandard Error 0.2
Standard BWLCoping Behaviors in Response to Weight StigmaMaladaptive Eating-0.8 scores on a scaleStandard Error 0.1
Standard BWLCoping Behaviors in Response to Weight StigmaHealthy Lifestyle0.0 scores on a scaleStandard Error 0.2
Standard BWLCoping Behaviors in Response to Weight StigmaFull Scale-0.9 scores on a scaleStandard Error 0.1
Comparison: Full Scalep-value: 0.61Mixed Models Analysis
Comparison: Negative Affectp-value: 0.73Mixed Models Analysis
Comparison: Maladaptive Eatingp-value: 0.94Mixed Models Analysis
Comparison: Healthy Lifestylep-value: 0.47Mixed Models Analysis
Comparison: Exercise Avoidancep-value: 0.99Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASDepression-2.9 scores on scaleStandard Error 0.9
Standard BWLDepression-2.4 scores on scaleStandard Error 0.9
p-value: 0.7Mixed Models Analysis
Other Pre-specified

Dietary Monitoring

Estimated mean change in number of days recording caloric intake

Time frame: Baseline to Week 26

ArmMeasureValue (MEAN)Dispersion
BWL + BIASDietary Monitoring85.6 number of daysStandard Error 9.5
Standard BWLDietary Monitoring95.8 number of daysStandard Error 9.2
p-value: 0.44Mixed Models Analysis
Other Pre-specified

Dietary Monitoring

Estimated mean change in number of days recording caloric intake

Time frame: Baseline to Week 12

ArmMeasureValue (MEAN)Dispersion
BWL + BIASDietary Monitoring52.9 number of daysStandard Error 3.4
Standard BWLDietary Monitoring55.5 number of daysStandard Error 3.4
p-value: 0.59Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASDisordered EatingEating Concern-0.6 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingWeight Concern-1.0 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingEating Restraint1.0 scores on a scaleStandard Error 0.3
BWL + BIASDisordered EatingShape Concern-1.1 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingGlobal-0.4 scores on a scaleStandard Error 0.1
Standard BWLDisordered EatingShape Concern-0.7 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingGlobal-0.2 scores on a scaleStandard Error 0.1
Standard BWLDisordered EatingEating Restraint0.7 scores on a scaleStandard Error 0.3
Standard BWLDisordered EatingEating Concern-0.3 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingWeight Concern-0.7 scores on a scaleStandard Error 0.2
Comparison: Globalp-value: 0.35Mixed Models Analysis
Comparison: Eating Restraintp-value: 0.46Mixed Models Analysis
Comparison: Eating Concernp-value: 0.33Mixed Models Analysis
Comparison: Weight Concernp-value: 0.18Mixed Models Analysis
Comparison: Shape Concernp-value: 0.16Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASDisordered EatingShape Concern-1.4 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingGlobal-0.5 scores on a scaleStandard Error 0.1
BWL + BIASDisordered EatingEating Restraint1.2 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingEating Concern-0.7 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingWeight Concern-1.2 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingWeight Concern-0.8 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingEating Concern-0.6 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingGlobal-0.3 scores on a scaleStandard Error 0.1
Standard BWLDisordered EatingShape Concern-1.0 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingEating Restraint1.0 scores on a scaleStandard Error 0.2
Comparison: Globalp-value: 0.3Mixed Models Analysis
Comparison: Eating Restraintp-value: 0.69Mixed Models Analysis
Comparison: Eating Concernp-value: 0.7Mixed Models Analysis
Comparison: Weight Concernp-value: 0.26Mixed Models Analysis
Comparison: Shape Concernp-value: 0.18Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASDisordered EatingGlobal-0.2 scores on a scaleStandard Error 0.1
BWL + BIASDisordered EatingEating Concern-0.4 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingWeight Concern-0.7 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingEating Restraint1.7 scores on a scaleStandard Error 0.2
BWL + BIASDisordered EatingShape Concern-1.1 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingEating Restraint1.5 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingEating Concern-0.7 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingShape Concern-0.9 scores on a scaleStandard Error 0.2
Standard BWLDisordered EatingGlobal-0.2 scores on a scaleStandard Error 0.1
Standard BWLDisordered EatingWeight Concern-0.7 scores on a scaleStandard Error 0.2
Comparison: Globalp-value: 0.83Mixed Models Analysis
Comparison: Eating Restraintp-value: 0.69Mixed Models Analysis
Comparison: Eating Concernp-value: 0.3Mixed Models Analysis
Comparison: Weight Concernp-value: 0.99Mixed Models Analysis
Comparison: Shape Concernp-value: 0.36Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASEating BehaviorsDietary Restraint6.3 scores on a scaleStandard Error 0.7
BWL + BIASEating BehaviorsDisinhibition-2.8 scores on a scaleStandard Error 0.6
BWL + BIASEating BehaviorsHunger-3.2 scores on a scaleStandard Error 0.5
Standard BWLEating BehaviorsDisinhibition-1.9 scores on a scaleStandard Error 0.6
Standard BWLEating BehaviorsDietary Restraint5.9 scores on a scaleStandard Error 0.7
Standard BWLEating BehaviorsHunger-1.4 scores on a scaleStandard Error 0.5
Comparison: Dietary Restraintp-value: 0.69Mixed Models Analysis
Comparison: Disinhibitionp-value: 0.28Mixed Models Analysis
Comparison: Hungerp-value: 0.02Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASEating BehaviorsHunger-3.9 scores on a scaleStandard Error 0.5
BWL + BIASEating BehaviorsDietary Restraint6.4 scores on a scaleStandard Error 0.8
BWL + BIASEating BehaviorsDisinhibition-3.0 scores on a scaleStandard Error 0.6
Standard BWLEating BehaviorsDisinhibition-2.2 scores on a scaleStandard Error 0.6
Standard BWLEating BehaviorsDietary Restraint5.2 scores on a scaleStandard Error 0.8
Standard BWLEating BehaviorsHunger-1.4 scores on a scaleStandard Error 0.5
Comparison: Dietary Restraintp-value: 0.29Mixed Models Analysis
Comparison: Disinhibitionp-value: 0.34Mixed Models Analysis
Comparison: Hungerp-value: 0.001Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASEating BehaviorsDietary Restraint3.5 scores on a scaleStandard Error 0.9
BWL + BIASEating BehaviorsDisinhibition-1.8 scores on a scaleStandard Error 0.5
BWL + BIASEating BehaviorsHunger-2.9 scores on a scaleStandard Error 0.6
Standard BWLEating BehaviorsDietary Restraint3.2 scores on a scaleStandard Error 0.9
Standard BWLEating BehaviorsDisinhibition-1.2 scores on a scaleStandard Error 0.6
Standard BWLEating BehaviorsHunger-0.7 scores on a scaleStandard Error 0.6
Comparison: Dietary Restraintp-value: 0.82Mixed Models Analysis
Comparison: Disinhibitionp-value: 0.45Mixed Models Analysis
Comparison: Hungerp-value: 0.007Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASEating Self-Efficacy8.3 scores on scaleStandard Error 3.4
Standard BWLEating Self-Efficacy1.0 scores on scaleStandard Error 3.4
p-value: 0.14Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASExercise Self-Efficacy-3.1 scores on a scaleStandard Error 4.9
Standard BWLExercise Self-Efficacy-6.8 scores on a scaleStandard Error 4.8
p-value: 0.59Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASPerceived Stress-2.4 scores on scaleStandard Error 1.3
Standard BWLPerceived Stress-0.1 scores on scaleStandard Error 1.2
p-value: 0.2Mixed Models Analysis
Other Pre-specified

Percent Weight Change

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

Time frame: Baseline to week 52

ArmMeasureValue (MEAN)Dispersion
BWL + BIASPercent Weight Change-3.1 percent weight changeStandard Error 1
Standard BWLPercent Weight Change-4.0 percent weight changeStandard Error 1
p-value: 0.53Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASSelf-Reported Self-Monitoring BehaviorsSelf-Reported Weighing0.9 scores on a scaleStandard Error 0.2
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Food/Drink2.7 scores on a scaleStandard Error 0.3
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Calories2.0 scores on a scaleStandard Error 0.3
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Activity1.6 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Activity0.8 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsSelf-Reported Weighing1.1 scores on a scaleStandard Error 0.2
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Calories1.7 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Food/Drink2.0 scores on a scaleStandard Error 0.3
Comparison: Self-Reported Weighingp-value: 0.46Mixed Models Analysis
Comparison: Track Food/Drinkp-value: 0.12Mixed Models Analysis
Comparison: Track Caloriesp-value: 0.42Mixed Models Analysis
Comparison: Track Activityp-value: 0.03Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASSelf-Reported Self-Monitoring BehaviorsSelf-Reported Weighing0.9 scores on a scaleStandard Error 0.2
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Food/Drink0.8 scores on a scaleStandard Error 0.2
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Calories1.2 scores on a scaleStandard Error 0.3
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Activity0.8 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Activity0.3 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsSelf-Reported Weighing0.5 scores on a scaleStandard Error 0.2
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Calories1.3 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Food/Drink0.7 scores on a scaleStandard Error 0.2
Comparison: Self-Reported Weighingp-value: 0.23Mixed Models Analysis
Comparison: Track Food/Drinkp-value: 0.48Mixed Models Analysis
Comparison: Track Caloriesp-value: 0.89Mixed Models Analysis
Comparison: Track Activityp-value: 0.3Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASSelf-Reported Self-Monitoring BehaviorsSelf-Reported Weighing1.0 scores on a scaleStandard Error 0.2
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Food/Drink1.6 scores on a scaleStandard Error 0.3
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Calories1.7 scores on a scaleStandard Error 0.3
BWL + BIASSelf-Reported Self-Monitoring BehaviorsTrack Activity1.3 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Activity0.9 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsSelf-Reported Weighing0.6 scores on a scaleStandard Error 0.2
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Calories1.4 scores on a scaleStandard Error 0.3
Standard BWLSelf-Reported Self-Monitoring BehaviorsTrack Food/Drink1.6 scores on a scaleStandard Error 0.3
Comparison: Self-Reported Weighingp-value: 0.23Mixed Models Analysis
Comparison: Track Food/Drinkp-value: 0.9Mixed Models Analysis
Comparison: Track Caloriesp-value: 0.36Mixed Models Analysis
Comparison: Track Activityp-value: 0.29Mixed Models Analysis
Other Pre-specified

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

Population: Participants randomized to the BWL + BIAS group did not receive (and thus did not rate) the recipe exchange component of treatment. Participants in the Standard BWL group did not receive (and did not rate) the BIAS treatment component.

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASTreatment Acceptability RatingsBWL component6.5 scores on a scaleStandard Error 0.9
BWL + BIASTreatment Acceptability RatingsBIAS component6.3 scores on a scaleStandard Error 1
Standard BWLTreatment Acceptability RatingsBWL component6.3 scores on a scaleStandard Error 1
Standard BWLTreatment Acceptability RatingsRecipe exchange5.4 scores on a scaleStandard Error 1.5
Comparison: BWL componentp-value: 0.32ANOVA
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASTreatment Acceptability Ratings6.5 scores on a scaleStandard Error 0.6
Standard BWLTreatment Acceptability Ratings6.2 scores on a scaleStandard Error 0.9
p-value: 0.14ANOVA
Other Pre-specified

Waist Circumference

Estimated mean change in waist circumference (cm)

Time frame: Baseline to week 52

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWaist Circumference-4.4 change in cmStandard Error 1
Standard BWLWaist Circumference-4.4 change in cmStandard Error 1
p-value: 0.99Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWeight Bias-0.4 scores on scaleStandard Error 0.1
Standard BWLWeight Bias-0.2 scores on scaleStandard Error 0.1
p-value: 0.21Mixed Models Analysis
Other Pre-specified

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

ArmMeasureValue (MEAN)Dispersion
BWL + BIASWeight Bias Internalization-1.5 scores on scaleStandard Error 0.2
Standard BWLWeight Bias Internalization-1.2 scores on scaleStandard Error 0.2
p-value: 0.25Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASWeight-Related Quality of LifeSexual Life13.3 scores on scaleStandard Error 3.7
BWL + BIASWeight-Related Quality of LifeTotal14.3 scores on scaleStandard Error 2.5
BWL + BIASWeight-Related Quality of LifeWork12.1 scores on scaleStandard Error 3.1
BWL + BIASWeight-Related Quality of LifeSelf Esteem20.0 scores on scaleStandard Error 3.9
BWL + BIASWeight-Related Quality of LifePublic Distress12.6 scores on scaleStandard Error 2.7
BWL + BIASWeight-Related Quality of LifePhysical Function12.4 scores on scaleStandard Error 3.1
Standard BWLWeight-Related Quality of LifePublic Distress7.6 scores on scaleStandard Error 2.7
Standard BWLWeight-Related Quality of LifePhysical Function13.2 scores on scaleStandard Error 3.1
Standard BWLWeight-Related Quality of LifeSelf Esteem17.7 scores on scaleStandard Error 3.9
Standard BWLWeight-Related Quality of LifeSexual Life11.6 scores on scaleStandard Error 3.6
Standard BWLWeight-Related Quality of LifeWork11.8 scores on scaleStandard Error 3.1
Standard BWLWeight-Related Quality of LifeTotal13.4 scores on scaleStandard Error 2.5
Comparison: Totalp-value: 0.81Mixed Models Analysis
Comparison: Physical Functionp-value: 0.86Mixed Models Analysis
Comparison: Self Esteemp-value: 0.87Mixed Models Analysis
Comparison: Sexual Lifep-value: 0.73Mixed Models Analysis
Comparison: Workp-value: 0.95Mixed Models Analysis
Comparison: Public Distressp-value: 0.19Mixed Models Analysis
Other Pre-specified

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

ArmMeasureGroupValue (MEAN)Dispersion
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-Total-5.6 scores on scaleStandard Error 1.6
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-SD-2.9 scores on scaleStandard Error 0.8
BWL + BIASWeight Self-Stigma Questionnaire (WSSQ)WSSQ-FNE-2.7 scores on scaleStandard Error 1
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-Total-3.1 scores on scaleStandard Error 1.6
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-SD-1.2 scores on scaleStandard Error 0.8
Standard BWLWeight Self-Stigma Questionnaire (WSSQ)WSSQ-FNE-2.0 scores on scaleStandard Error 1
Comparison: WSSQ-Totalp-value: 0.27Mixed Models Analysis
Comparison: WSSQ-SDp-value: 0.13Mixed Models Analysis
Comparison: WSSQ-FNEp-value: 0.65Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026