Clinical trial NCT06389656: Addressing Weight Bias Internalization to Improve Adolescent Weight Management Outcomes: Open Trial
Official title: Piloting an Intervention to Address Weight Bias Internalization to Improve Adolescent Weight Management Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Body Weight
Weight Bias
Weight Stigma
Weight
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 17
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open trial
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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total score on an adapted version of the Acceptability of Intervention Measure (AIM)
timeFrame: Post-Treatment (5 months)
measure: In depth qualitative feedback from teens regarding intervention acceptability and feasibility
timeFrame: Post-Treatment (5 months)
measure: Attendance rates at intervention sessions
timeFrame: Post-Treatment (5 months)
measure: Retention rate for intervention sessions
timeFrame: Post-Treatment (5 months)
Secondary outcomes:
measure: Total score on the Modified Weight Bias Internalization Scale (WBIS-M)
timeFrame: Baseline, Post-Treatment (5 months)
measure: Total score on the Weight Self-Stigma Questionnaire (WSSQ)
timeFrame: Baseline, Post-Treatment (5 months)
measure: Total score on the weight-related teasing sub-scale of the Perception of Teasing Scale (POTS)
timeFrame: Baseline, Post-Treatment (5 months)
measure: Total score on the competency-related teasing subscale of the Perception of Teasing Scale (POTS)
timeFrame: Baseline, Post-Treatment (5 months)
measure: Anthropometrics
timeFrame: Baseline, Post-Treatment (5 months)
Other outcomes:
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: