Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Open Trial

NCT06389656 | Completed

• 1 other identifier: 1K23DK135791-01
• Study Type: interventional
• Target: 17
• 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 intervention for weight stigma and WBI in conjunction with an evidence-based adolescent weight management program. Adolescents (ages 13-17) will participate in a 20-week program tailored to improve WBI and weight-related health behaviors in tandem. Primary outcomes are feasibility and acceptability of the developed intervention, assessed following the 20-week intervention.

Conditions

Body Weight; Weight Bias; Weight; Weight Stigma

Outcome Measures

Primary Outcomes (4)

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

  Intervention acceptability refers to the extent to which the WBI+BWC intervention is agreeable, palatable, or satisfactory to adolescents engaging in the treatment. We adapted the validated Acceptability of Intervention Measure (AIM) to assess adolescent acceptance related to treatment components following each intervention session. Total scores range from 10-50, with higher scores indicative of higher levels of intervention acceptability.

  Post-Treatment (5 months)

• In depth qualitative feedback from teens regarding intervention acceptability and feasibility

  Intervention acceptability refers to the extent to which the WBI+BWC intervention is agreeable, palatable, or satisfactory to adolescents engaging in the treatment. Adolescents will participate in individual qualitative interviews to gather in depth information concerning acceptability and feasibility. Findings will be used to tailor treatment delivery and content to optimize acceptability and appropriateness of the treatment for adolescents.

  Post-Treatment (5 months)

• Attendance rates at intervention sessions

  Feasibility includes the extent to which adolescents are able to utilize the intervention components offered. Attendance at group sessions will be used to measure feasibility, with the minimal benchmark set at 75%.

  Post-Treatment (5 months)

• Retention rate for intervention sessions

  Feasibility includes the extent to which adolescents are able to utilize the intervention components offered. Retention, as measured by the drop-out rate for the intervention program, will be used to measure feasibility, with the minimal benchmark set at 80%.

  Post-Treatment (5 months)

Secondary Outcomes (5)

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

  Baseline, Post-Treatment (5 months)

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

  Baseline, Post-Treatment (5 months)

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

  Baseline, Post-Treatment (5 months)

• Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS)

  Baseline, Post-Treatment (5 months)

• Anthropometrics

  Baseline, Post-Treatment (5 months)

Study Arms (1)

WBI+BWM

EXPERIMENTAL

WBI+BWM will be 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

Interventions

Behavioral Weight Management BEHAVIORAL

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

WBI+BWM

Weight Bias Internalization BEHAVIORAL

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

WBI+BWM

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• 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

Sponsors & Collaborators

• The Miriam Hospital: lead

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Body Weight; Weight Prejudice

Condition Hierarchy (Ancestors)

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

Study Officials

• Katherine Darling, PhD

  The Miriam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open trial

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 29, 2024
• Study Start: April 8, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 15, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)