FIT Families Multicomponent Obesity Intervention for African American Adolescents

StatusActive, Not Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 30, 2026 → Nov 30, 2026
See other at-risk trials from Medical University of South Carolina

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 30, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 33 of 51 entries
    • Publications: details revised at 2 of 2 entries
  2. Primary completion pushed from Apr 30, 2026 to Sep 30, 2026v11
  3. Re-verified, no change to tracked fieldsv10
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v9
  5. Primary endpoints revised (12)
    • Secondary endpoints revised (51)
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Publications: 1 to 2v7
  2. 2 versions Re-verified since May 3, 2022, no change to tracked fieldsv5-v6
  3. Primary completion date: Jan 1, 2022 to Apr 30, 2026
    • Study completion date: Apr 30, 2022 to Nov 30, 2026
    • Start date: Oct 4, 2021 to May 1, 2021
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Oct 1, 2021 to Oct 4, 2021
    • Site details revised
    v3
  5. Start date: Aug 1, 2021 to Oct 1, 2021v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04974554
Lead Sponsor Medical University of South Carolina
Collaborators: National Heart, Lung, and Blood Institute (NHLBI), Florida State University, Wayne State University
Conditions
(from sponsor)		 Obesity, Childhood, Metabolic Syndrome
Related terms Metabolic Syndrome, Obesity, Pediatric Obesity
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov