Clinical trial NCT06864208: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Randomized Pilot Trial
Official title: Piloting an Intervention to Address Weight Bias Internalization to Improve Adolescent Weight Management Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 64
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized pilot trial with active comparator
Primary purpose: TREATMENT

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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

1) Speak English; 2) 13-17 years of age; 3) BMI at or above \>95th%ile for age and sex; 4) Have at least one caregiver available to provide consent and participate in sessions; 5) Agree to study participation

Exclusion Criteria:

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

Primary outcomes:
measure: Total score on the Modified Weight Bias Internalization Scale (WBIS-M)
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
measure: Total score on the Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
measure: Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS)
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
measure: Average (AUC) for diurnal cortisol
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
measure: Concentration of c-reactive protein (CRP)
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
measure: Concentration of interleukin-6 (IL-6)
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
measure: Dysregulated Eating Behaviors
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Secondary outcomes:
measure: Attendance rates at intervention sessions
timeFrame: Post-Treatment (5 months)
measure: Retention rate for intervention sessions
timeFrame: Post-Treatment (5 months)
measure: Total score on an adapted version of the Acceptability of Intervention Measure (AIM)
timeFrame: Data collected after each intervention session (20 sessions, 20 weeks)
Other outcomes:
measure: Anthropometrics
timeFrame: Baseline, 4-weeks post-intervention start, Post-Treatment (20 weeks)
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Katherine Darling, PhD
role: PRINCIPAL_INVESTIGATOR
References: