Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-04 @ 8:35 AM
Study NCT ID:
NCT06864208
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Randomized Pilot Trial
Sponsor:
The Miriam Hospital
Organization:
Study Overview
Official Title:
Piloting an Intervention to Address Weight Bias Internalization to Improve Adolescent Weight Management Outcomes
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SWIFT
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: