Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Randomized Pilot Trial

NCT06864208 | Recruiting

• 1 other identifier: 1K23DK135791-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Weight stigma and weight bias internalization (WBI) are common among adolescents at higher weight statuses. WBI is associated with negative physical and mental health outcomes. The current study aims to test an intervention for weight stigma and WBI combined with an evidence-based adolescent weight management program. Eligible adolescents (13-17) will be assigned by chance to one of two groups: 1) a 4-week intervention focused on weight stigma and WBI followed by a 16-week behavioral weight management program; or 2) a 4-week health information control (to include non-weight-related health promotion topics such as smoking and skin cancer prevention) followed by the same 16-week weight management program but without the WBI and weight stigma content. Study outcomes will be assessed at the 4-week and post-treatment (20 week) timepoints.

Conditions

Weight; Body Weight; Weight Bias; Weight Stigma; Physiological Stress; Biological Markers of Stress; Biological Markers of Inflammation; Eating Behaviors

Keywords

Adolescents; Teens; Weight; C-reactive protein; CRP; Interleukin-6; IL-6; Eating behaviors; Behavioral weight management; Weight bias; Weight stigma

Outcome Measures

Primary Outcomes (7)

• Total score on the Modified Weight Bias Internalization Scale (WBIS-M)

  The validated Modified Weight Bias Internalization Scale (WBIS-M) assesses the degree to which people apply negative weight-based stereotypes to themselves and judge themselves negatively due to their weight. Total scores range from 1 to 77, with higher scores indicating a greater degree of WBI.

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

• Total score on the Weight Self-Stigma Questionnaire (WSSQ)

  The Weight Self-Stigma Questionnaire (WSSQ) measures weight-related self-devaluation and fear of enacted stigma. Total scores range from 12 to 60, with higher scores indicating a greater degree of internalized stigma.

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

• Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS)

  The validated Perception of Teasing Scale (POTS) will be used to measure adolescents' experiences of weight based stigma separate from WBI. The scale has two sub-scales: a weight-related teasing sub-scale and a competency-related teasing subscale. Total scores on the weight-related teasing sub-scale range from 6-30, with higher scores indicating a higher frequency of historical weight-based teasing.

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

• Average (AUC) for diurnal cortisol

  Samples will be collected by teens at home over the course of 2 consecutive days following each assessment timepoint. A total of six samples will be collected with three samples each day: a sample immediately upon waking, another 30-60 minutes after waking, and a final sample at bedtime. Area under the curve (AUC) will be calculated for diurnal cortisol. The average AUC over the course of two days at each assessment timepoint will be used in analyses.

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

• Concentration of c-reactive protein (CRP)

  Circulating concentration of CRP will be determined using a high-sensitivity assay based on particle enhanced immunonephelometry.

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

• Concentration of interleukin-6 (IL-6)

  IL-6 concentration will be determined by specific enzyme-linked immunosorbent assay.

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

• Dysregulated Eating Behaviors

  Disordered eating will be measured using the 36-item Eating Disordered Examination Questionnaire.

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

Secondary Outcomes (3)

• Attendance rates at intervention sessions

  Post-Treatment (5 months)

• Retention rate for intervention sessions

  Post-Treatment (5 months)

• Total score on an adapted version of the Acceptability of Intervention Measure (AIM)

  Data collected after each intervention session (20 sessions, 20 weeks)

Other Outcomes (1)

• Anthropometrics

  Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)

Study Arms (2)

Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM)

EXPERIMENTAL

WBI+BWM is a multicomponent behavioral weight loss intervention designed to address both weight bias internalization and weight status in adolescents. The first four sessions of the intervention will be focused on targeted WBI/weight stigma content, followed by 16 sessions addressing both weight stigma/WBI and evidence-based weight management strategies. Weekly meetings are scheduled for 75 minutes and are facilitated by a behavioral expert (e.g., PhD in clinical psychology). Caregivers attend 4 of the 20 weekly groups with their teens.

Behavioral: Behavioral Weight Management; Behavioral: Weight Bias Internalization

Health Information Control + Behavioral Weight Management Intervention (HIC + BWM)

ACTIVE COMPARATOR

The first four sessions (weeks 1-4) of the HIC+BWM group will focus on health promotion for adolescent health concerns other than weight management (e.g., skin cancer prevention, smoking cessation). This health information control will allow for testing of the initial 4- week WBI intervention as compared to a contact-matched control. Following the four-week health education control, the remaining 16 sessions will focus on evidence-based weight management strategies. Caregivers attend 4 of the 20 weekly groups with their teens.

Behavioral: Behavioral Weight Management

Interventions

Behavioral Weight Management BEHAVIORAL

Prescription of diet and physical activity strategies paired with behavioral strategies for weight management

Health Information Control + Behavioral Weight Management Intervention (HIC + BWM); Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM)

Weight Bias Internalization BEHAVIORAL

Addressing weight stigma and improving weight-related self-perception through challenging weight-related stereotypes, practicing self-compassion, reducing self-criticism, and coping with weight stigma

Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Speak English;
• years of age;
• BMI at or above \>95th%ile for age and sex;
• Have at least one caregiver available to provide consent and participate in sessions;
• Agree to study participation;

You may not qualify if:

• Cognitive impairment or developmental delay impairing participation in a group setting;
• Current participation in a weight management program or recent weight loss of 5% of body weight or more;
• Medical condition known to impact weight or that would otherwise prevent participation;
• Current use of glucagon-like peptide-1 (GLP-1) receptor agonists;

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Body Weight; Weight Prejudice; Feeding Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Prejudice; Social Behavior; Behavior; Behavior, Animal

Study Officials

• Katherine Darling, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Darling, PhD

CONTACT

401-793-8688; katherine_darling@brown.edu

Andrea M Grenga, BA

CONTACT

401-793-8997; agrenga@brownhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized pilot trial with active comparator

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 7, 2025
• Study Start: March 25, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (1)