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

NCT ID: NCT06389656

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-08

Study Completion Date

2025-02-15

Brief Summary

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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

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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.

Conditions

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Body Weight Weight Bias Weight Stigma Weight

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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WBI+BWM

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.

Group Type EXPERIMENTAL

Behavioral Weight Management

Intervention Type BEHAVIORAL

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

Weight Bias Internalization

Intervention Type 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.

Interventions

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Behavioral Weight Management

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

Intervention Type BEHAVIORAL

Weight Bias Internalization

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* speak English
* 13-17 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

Exclusion Criteria

* 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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine Darling, PhD

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital

Locations

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The Miriam Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1K23DK135791-01

Identifier Type: NIH

Identifier Source: org_study_id

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