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

Phase

N/A

Condition

Inflammation

Stress

Treatment

Weight Bias Internalization

Behavioral Weight Management

Clinical Study ID

NCT06864208

1K23DK135791-02

1K23DK135791

Ages 13-17
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Speak English; 2) 13-17 years of age; 3) BMI at or above >95th%ile for age and sex;
Have at least one caregiver available to provide consent and participate insessions; 5) Agree to study participation

Exclusion

Exclusion Criteria:

Cognitive impairment or developmental delay impairing participation in a groupsetting; 2) Current participation in a weight management program or recent weightloss of 5% of body weight or more; 3) Medical condition known to impact weight orthat would otherwise prevent participation; 4) Current use of glucagon-likepeptide-1 (GLP-1) receptor agonists

Study Design

Weight Bias Internalization

March 01, 2025

February 28, 2027

Study Description

The overall goal of this project is to examine the impact of intervening on weight bias internalization (WBI) in conjunction with evidence-based adolescent behavioral weight management (BWM) and to assess reduction in key mechanisms of stress resulting from weight stigma (i.e., biological markers of stress and inflammation, dysregulated eating behaviors) and subsequent impact on weight loss interference resulting from WBI.

An open trial was previously conducted to test initial acceptability and feasibility of a newly developed 20-week WBI+BWM intervention (ClinicalTrials.gov ID: NCT06389656). The intervention consisted of 4 weeks of WBI followed by a 16-week BWM intervention with integrated WBI and weight stigma content. Quantitative and qualitative feedback concerning acceptability and feasibility were solicited to refine the intervention. The current study is a randomized trial that will compare the 20-week WBI+BWM intervention developed in the open trial to a Health Information Control (HIC) + BWM condition. The HIC+BWM intervention consists of a 4-week health information control (consisting of non-weight-related health promotion topics such as smoking and skin cancer) followed by the same 16-week BMI, but without WBI and weight stigma content.

Primary and secondary outcomes will be assessed at the 4- and 20-week (post-treatment) timepoints. This study will evaluate the impact of the interventions on WBI, biological markers of stress and inflammation (cortisol, CRP, IL-6), and dysregulated eating behaviors. Changes in weight status will also be examined. Feasibility and acceptability will be measured during the pilot RCT to ensure ongoing fit of the intervention to the adolescent population. Data will provide effect size estimates of the impact on adolescent BMI for a large-scale randomized controlled trial (RCT).

Connect with a study center

The Miriam Hospital
Providence, Rhode Island 02903
United States
Active - Recruiting

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