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NCT06482944 · ClinicalTrials.gov registry record · NA
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
A NA study of PreDiabetes and Diet, Healthy, sponsored by Vanderbilt University.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06482944: Recruiting NA study of PreDiabetes and Diet, Healthy, sponsored by Vanderbilt University.
NCT06482944 is a NA study of PreDiabetes and Diet, Healthy that is actively recruiting participants, run by Vanderbilt University. The registered enrollment target is 30 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06482944, a NA study of PreDiabetes and Diet, Healthy, is actively recruiting participants, sponsored by Vanderbilt University.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will address the following aims: Aim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet. Feasibility: ≥80% participant retention and completion of study outcome measures. Acceptability: ≥75 adult diet satisfaction via survey report and/or perceived diet satisfaction via focus groups. Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult/child diet quality during the 12-week intervention. Aim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes. Hypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group. Aim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group. Aim 3: Conduct family focus groups to understand how SDOH and individual/family needs and preferences may be perceived barriers or facilitators of diet adherence.
Primary Outcome
Feasibility will be based on ≥80% participant retention and completion of outcome measures (e.g., HbA1c testing, anthropometry, surveys, diet checklists/recalls). Diet acceptability will be based on ≥75% adult diet satisfaction via survey report (using the acceptability measure).
Conditions Studied
Interventions
- BEHAVIORAL Whole Foods for Families
Study Locations (1)
Tennessee
- Vanderbilt University School of Nursing - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-10-13 |
| Est. Completion | 2027-06-30 |
| Phase | NA |
What NCT06482944 shows while recruiting
NCT06482944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with PreDiabetes appearing as the primary indexed condition, and to 1 intervention - of which Whole Foods for Families is the first listed.
NCT06482944 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT06482944 about?
NCT06482944 is a clinical study titled "Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes". This study will address the following aims: Aim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet. Feasibility: ≥80% participant retention and co...
What is the current status of trial NCT06482944?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2025-10-13. Estimated completion is 2027-06-30.
What conditions does trial NCT06482944 study?
This clinical trial studies the following conditions: PreDiabetes, Diet, Healthy, Nutritional and Metabolic Diseases.
What interventions are being tested in trial NCT06482944?
The interventions under investigation include: Whole Foods for Families (BEHAVIORAL).
Who is sponsoring clinical trial NCT06482944?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06482944 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 NCT06482944's enrollment target sits among peer trials
30 118th of 149 higher than 23 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes 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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