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NCT06464497 · ClinicalTrials.gov registry record · NA
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
A NA study of Obesity, Childhood and Diet, Healthy, sponsored by Vanderbilt University.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06464497: Recruiting NA study of Obesity, Childhood and Diet, Healthy, sponsored by Vanderbilt University.
NCT06464497 is a NA study of Obesity, Childhood and Diet, Healthy that is actively recruiting participants, run by Vanderbilt University. The registered enrollment target is 60 participants, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06464497, a NA study of Obesity, Childhood and Diet, Healthy, is actively recruiting participants, sponsored by Vanderbilt University.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Body adiposity will be measured using DXA at the VUIIS with a Hologic Horizon series W scanner (Marlborough, MA). Total body fat mass (primary outcome), trunk fat mass, lean body mass (LBM) in kg, and total body %fat will be recorded.
Conditions Studied
Interventions
- BEHAVIORAL Whole Foods MyPlate Group
Study Locations (1)
Tennessee
- Vanderbilt University School of Nursing - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-03-24 |
| Est. Completion | 2027-04-30 |
| Phase | NA |
What NCT06464497 shows while recruiting
NCT06464497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 343-participant average among 53 other Obesity, Childhood trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with Obesity, Childhood appearing as the primary indexed condition, and to 1 intervention - of which Whole Foods MyPlate Group is the first listed.
NCT06464497 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06464497 about?
NCT06464497 is a clinical study titled "Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity". 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. Hypoth...
What is the current status of trial NCT06464497?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-03-24. Estimated completion is 2027-04-30.
What conditions does trial NCT06464497 study?
This clinical trial studies the following conditions: Obesity, Childhood, Diet, Healthy, Body Weight Changes.
What interventions are being tested in trial NCT06464497?
The interventions under investigation include: Whole Foods MyPlate Group (BEHAVIORAL).
Who is sponsoring clinical trial NCT06464497?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06464497 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06464497's enrollment target sits among peer trials
60 40th of 53 higher than 10 of 53 other Obesity, Childhood trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity, Childhood trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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