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

Lifespan

Status: Enrolling

Conditions: Physiological Stress; Weight Bias; Weight Stigma; Biological Markers of Inflammation; Body Weight; Eating Behaviors; Weight; Biological Markers of Stress

Treatments: Behavioral: Behavioral Weight Management; Behavioral: Weight Bias Internalization

Study type: Interventional

Funder types: Other

Identifiers

NCT06864208

1K23DK135791-02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 64 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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;
• Current use of glucagon-like peptide-1 (GLP-1) receptor agonists;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Weight Bias Internalization + Behavioral Weight Management Intervention (WBI + BWM)

Experimental group

Description:

WBI+BWM is 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.

Treatment:

Behavioral: Weight Bias Internalization

Behavioral: Behavioral Weight Management

Health Information Control + Behavioral Weight Management Intervention (HIC + BWM)

Active Comparator group

Description:

The first four sessions (weeks 1-4) of the HIC+BWM group will focus on health promotion for adolescent health concerns other than weight management (e.g., skin cancer prevention, smoking cessation). This health information control will allow for testing of the initial 4- week WBI intervention as compared to a contact-matched control. Following the four-week health education control, the remaining 16 sessions will focus on evidence-based weight management strategies. Caregivers attend 4 of the 20 weekly groups with their teens.

Treatment:

Behavioral: Behavioral Weight Management