NCT03572218

Psychological Intervention to Reduce Weight Bias Internalization

Completed NA Results posted Last updated 23 October 2020

What this trial tests

NA trial testing BWL in Stigmatization in 72 participants. Completed in 18 October 2019.

Timeline

10 April 2018

Primary endpoint
9 April 2019

18 October 2019

Quick facts

Lead sponsor	University of Pennsylvania
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	72
Start date	10 April 2018
Primary completion	9 April 2019
Estimated completion	18 October 2019
Sites	1 location across United States

Drugs / interventions tested

• BWL
• BIAS

Conditions studied

• Stigmatization — all drugs for Stigmatization →
• Obesity — all drugs for Obesity →
• Weight Loss — all drugs for Weight Loss →

Sponsor

University of Pennsylvania

Who can join

Adults 18 to 65, any sex, with Stigmatization or Obesity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Weight Bias Internalization Primary · Baseline to week 12

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

Group	Value	95% CI
BWL + BIAS	-1.3	± 0.2
Standard BWL	-1.0	± 0.2

Weight Bias Internalization Secondary · Baseline to week 26

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

Group	Value	95% CI
BWL + BIAS	-1.5	± 0.2
Standard BWL	-1.3	± 0.2

Weight Self-Stigma Questionnaire (WSSQ) Secondary · Baseline to week 12

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

WSSQ-Total

Group	Value	95% CI
BWL + BIAS	-6.0	± 1.4
Standard BWL	-1.6	± 1.3

WSSQ-SD

Group	Value	95% CI
BWL + BIAS	-3.6	± 0.8
Standard BWL	-1.0	± 0.8

WSSQ-FNE

Group	Value	95% CI
BWL + BIAS	-2.3	± 0.8
Standard BWL	-0.7	± 0.8

Weight Self-Stigma Questionnaire (WSSQ) Secondary · Baseline to week 26

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

WSSQ-Total

Group	Value	95% CI
BWL + BIAS	-7.1	± 1.5
Standard BWL	-3.6	± 1.5

WSSQ-SD

Group	Value	95% CI
BWL + BIAS	-4.1	± 0.8
Standard BWL	-1.5	± 0.8

WSSQ-FNE

Group	Value	95% CI
BWL + BIAS	-2.9	± 0.9
Standard BWL	-2.1	± 0.9

Weight Bias Secondary · Baseline to week 12

Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

Group	Value	95% CI
BWL + BIAS	-0.5	± 0.1
Standard BWL	-0.2	± 0.1

Weight Bias Secondary · Baseline to week 26

Estimated mean change score on the Fat Phobia Scale (scale scoring 1-5; higher scores indicate greater weight bias)

Group	Value	95% CI
BWL + BIAS	-0.5	± 0.1
Standard BWL	-0.2	± 0.1

Weight-Related Quality of Life Secondary · Baseline to week 12

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)

Total

Group	Value	95% CI
BWL + BIAS	8.3	± 2.1
Standard BWL	8.9	± 2.0

Physical Function

Group	Value	95% CI
BWL + BIAS	9.8	± 2.9
Standard BWL	8.8	± 2.8

Self Esteem

Group	Value	95% CI
BWL + BIAS	12.9	± 3.0
Standard BWL	9.2	± 3.0

Sexual Life

Group	Value	95% CI
BWL + BIAS	5.5	± 3.6
Standard BWL	9.5	± 3.5

Work

Group	Value	95% CI
BWL + BIAS	4.8	± 3.1
Standard BWL	6.9	± 3.0

Public Distress

Group	Value	95% CI
BWL + BIAS	5.7	± 2.6
Standard BWL	7.7	± 2.6

Weight-Related Quality of Life Secondary · Baseline to week 26

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)

Total

Group	Value	95% CI
BWL + BIAS	12.5	± 2.1
Standard BWL	14.1	± 2.1

Physical Function

Group	Value	95% CI
BWL + BIAS	13.7	± 2.9
Standard BWL	14.2	± 2.8

Self Esteem

Group	Value	95% CI
BWL + BIAS	19.1	± 3.4
Standard BWL	18.5	± 3.3

Sexual Life

Group	Value	95% CI
BWL + BIAS	7.0	± 3.6
Standard BWL	14.0	± 3.5

Work

Group	Value	95% CI
BWL + BIAS	8.6	± 3.1
Standard BWL	6.8	± 3.0

Public Distress

Group	Value	95% CI
BWL + BIAS	9.9	± 2.6
Standard BWL	11.2	± 2.6

Perceived Stress Secondary · Baseline to week 12

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

Group	Value	95% CI
BWL + BIAS	-3.2	± 1.2
Standard BWL	-0.1	± 1.2

Perceived Stress Secondary · Baseline to week 26

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

Group	Value	95% CI
BWL + BIAS	-3.9	± 1.2
Standard BWL	-1.0	± 1.2

Depression Secondary · Baseline to week 12

Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

Group	Value	95% CI
BWL + BIAS	-3.4	± 0.8
Standard BWL	-2.5	± 0.8

Depression Secondary · Baseline to week 26

Estimated mean change score on the Patient Health Questionnaire - 9 (summed 0-27; higher scores indicate more symptoms of depression)

Group	Value	95% CI
BWL + BIAS	-2.9	± 0.8
Standard BWL	-2.9	± 0.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Week 1 through week 26. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BWL + BIAS

Serious: 0/36 (0%)

Deaths: 0/36

Standard BWL

Serious: 1/36 (3%)

Deaths: 0/36

Serious adverse events (1 terms)

Reaction	System	BWL + BIAS	Standard BWL
Hypokalemia	Renal and urinary disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	BWL + BIAS	Standard BWL
Viral gastroenteritis	Gastrointestinal disorders	—	—
Asthma exacerbation	Respiratory, thoracic and mediastinal disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Knee pain	Musculoskeletal and connective tissue disorders	—	—

Most-reported serious reactions: Hypokalemia.

Data from ClinicalTrials.gov NCT03572218 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of a cognitive-behavioral intervention targeting weight stigma: A randomized controlled trial.
   Pearl RL, Wadden TA, Bach C, Gruber K, et al · · 2020 · cited 50× · PMID 31971410 · DOI 10.1037/ccp0000480
2. Six-Month Follow-up from a Randomized Controlled Trial of the Weight BIAS Program.
   Pearl RL, Wadden TA, Bach C, Tronieri JS, et al · · 2020 · cited 12× · PMID 32860344 · DOI 10.1002/oby.22931