FIT Families Multicomponent Obesity Intervention for African American Adolescents

NCT04974554 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-06

No results posted yet for this study

Summary

Obesity is one of the most prevalent medical problems facing children and adolescents today, particularly among African American adolescents where the rate is alarmingly high. This study will test the effectiveness of FIT Families, a multicomponent family-based behavioral intervention that is culturally tailored to meet the unique needs of African American adolescents with obesity and their caregivers, against a credible attention control condition. This study has considerable public health relevance because it is delivered by Community Health Workers, maximizing the potential for the intervention to be sustained, and may reduce obesity-related health problems for a vulnerable population of adolescents.

Conditions

Interventions

BEHAVIORAL

FIT

FIT Families is a home-based intervention that works with youth and caregivers to lose weight and improve their health. The intervention lasts 6 months. Sessions are held twice a week for the first 3 months and then once a week for the second 3 months. These sessions will take place in home with a community health worker. In addition, participants will have the opportunity to earn prizes for completing certain intervention related tasks.

BEHAVIORAL

Home-Based Family Support

Home-Based Family Support Group will receive six months of weekly family counseling in the home. The weekly visits have 3 goals: 1) provide basic education in nutrition and physical recommendations for adolescent and adult obesity; 2) assess and monitor weight, physical activity, and diet via logs; and 3) offer opportunities to discuss barriers they identify to adherence to weight loss recommendations. The HBFS CHW will also address non-weight related problems such as peer or family relationship problems during the visits.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Florida State University

    collaborator OTHER
  • Wayne State University

    collaborator OTHER
  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Mohan Madisetti, Ph.D. · Medical University of South Carolina

  • Phillippe B Cunningham, PhD · UTHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04974554 on ClinicalTrials.gov