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Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Enrollment target: 30 to 60
    • Primary completion date: Jun 30, 2026 to Dec 31, 2026
    • Study completion date: Jun 30, 2026 to Apr 30, 2027
    • Study description shortened, about 3 words
    v7
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Apr 30, 2025 to Mar 24, 2025
    • Site details revised
    v6
  3. Notable Primary and study completion dates: Dec 31, 2025 to Jun 30, 2026
    • Start date: Jan 31, 2025 to Apr 30, 2025
    v5
  4. Notable Start date: Nov 4, 2024 to Jan 31, 2025
    • Primary and study completion dates: Oct 30, 2025 to Dec 31, 2025
    v4
  5. Notable Start date: Sep 1, 2024 to Nov 4, 2024
    • Primary and study completion dates: Jun 30, 2025 to Oct 30, 2025
    v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
3,874 trials monitored
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This study will address the following aims: Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity. Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention. Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group. Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention. Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group. Secondary Aims: Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period. Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group. Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.
Trial Details
NCT Number NCT06464497
Lead Sponsor Vanderbilt University
Collaborators: Vanderbilt University Medical Center
Conditions
(from sponsor)
Obesity, Childhood, Diet, Healthy, Body Weight Changes
Related terms Body Weight Changes, Pediatric Obesity
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov