Viewing Study NCT06389656


Ignite Creation Date: 2025-12-24 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
Study NCT ID: NCT06389656
Status: COMPLETED
Last Update Posted: 2025-12-22
First Post: 2024-04-17
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Open 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: COMPLETED
Status Verified Date: 2025-12
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 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.
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 with 16 adolescents (2 cohorts; 8/group) will be conducted to test initial acceptability and feasibility of the 20-week WBI+BWM intervention in an open trial. Quantitative and qualitative feedback concerning acceptability and feasibility will be solicited to refine the intervention. Participants are adolescents (ages 13-17 years old) at higher weight status (BMI percentile at or equal to the 95th percentile) will participate in a 20-session weekly intervention focused on weight bias internalization and healthy weight management strategies.

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?: None
Is an FDA AA801 Violation?: