An Acceptance-Based Healthy Lifestyle Intervention for Diverse Adolescents

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Drexel University
Study ID
NCT06147973
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
14 Years - 19 Years
Healthy Volunteers
Accepted

Interventions

  • Acceptance-based Treatment (ABT) — BEHAVIORAL
    Participants will be provided with psycho-education, skill-builders, and other coaching to promote weight loss and healthy lifestyle changes.
  • Health Education (HE) Comparison — BEHAVIORAL
    Participants will be provided with psych-education and resources to promote weight loss and healthy lifestyle changes. They will not be provided with directives.

Study Details

The goal of this clinical trial is to learn about cardiovascular disease risk among adolescent girls with overweight/obesity. The main questions this trial aims to answer are: 1. Does an acceptance-based healthy lifestyle intervention demonstrate more weight loss than a health education intervention? 2. Does an acceptance-based healthy lifestyle intervention show more improvements in participants' physiological, health-related, and psychological factors compared to a health education intervention? Participants in this trial will: 1. Engage in treatment for 6-months, comprising of a mixture of in-person and remote group sessions, occurring at Drexel University or over a video-conferencing platform. 2. Complete various assessments. These include self-reported questionnaires, measures of weight, height, body composition, blood pressure, and blood lipids, and wearing of smart watches to measure sleep and physical activity. Researchers will compare the acceptance-based and health education intervention groups to see if the acceptance-based treatment will indeed be effective in improving participants' health outcomes.

Key Dates

Start date
Feb 14, 2024
Status verified
Apr 2024
Primary completion
Jan 1, 2028
Completion
Jan 1, 2028

Study Design

Enrollment
148 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acceptance-based Treatment (ABT)
    ABT will consist of 18, 90-minute group sessions over 6 months.
  • Sham Comparator: Health Education (HE) Comparison
    HE will include nine, 75-minute group health education sessions handouts over 6 months.

Primary Outcome Measure

BMI z-score change [ Time Frame: Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Drexel UniversityPhiladelphiaPennsylvania19104
Stephanie Manasse, PhD
[email protected]
215-553-7157

Find similar trials in Philadelphia, PA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Drexel University· Philadelphia, PA

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