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Behavioral Intervention
Behavioral Program for Obesity (SWIFT Trial)
N/A
Recruiting
Led By Katherine Darling, PhD
Research Sponsored by The Miriam Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must be 13-17 years of age
BMI at or above >95th percentile for age and sex
Must not have
Cognitive impairment or developmental delay impairing participation in a group setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-treatment (5 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test an intervention program for weight stigma and weight bias internalization in adolescents with higher weight statuses. The program will run for 20 weeks and is designed to improve mental and physical health
Who is the study for?
This trial is for adolescents aged 13-17 who experience weight discrimination and have a higher weight status. The focus is on those willing to participate in a 20-week program designed to address weight bias internalization (WBI) and improve health behaviors.
What is being tested?
The study tests an intervention aimed at reducing the negative effects of WBI while participating in an established adolescent weight management program. Success will be measured by how feasible and acceptable participants find this combined approach after the program ends.
What are the potential side effects?
Since this trial involves behavioral interventions, there may not be physical side effects like with medication. However, participants might experience emotional discomfort or stress as they confront issues related to weight bias.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 13 and 17 years old.
Select...
My BMI is in the top 5% for my age and gender.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have cognitive issues that make group activities challenging.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-treatment (5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-treatment (5 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Attendance rates at intervention sessions
In depth qualitative feedback from teens regarding intervention acceptability and feasibility
Retention rate for intervention sessions
+1 moreSecondary study objectives
Anthropometrics
Total score on the Modified Weight Bias Internalization Scale (WBIS-M)
Total score on the Weight Self-Stigma Questionnaire (WSSQ)
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: WBI+BWMExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
The Miriam HospitalLead Sponsor
244 Previous Clinical Trials
37,848 Total Patients Enrolled
76 Trials studying Obesity
15,096 Patients Enrolled for Obesity
Katherine Darling, PhDPrincipal InvestigatorThe Miriam Hospital
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