Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University
Study ID
NCT06482944
Status
Recruiting
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Conditions

  • Diet, Healthy
  • Nutritional and Metabolic Diseases
  • PreDiabetes

Eligibility Criteria

Sex
ALL
Age
6 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • Whole Foods for Families — BEHAVIORAL
    This diet intervention will encourage the consumption of a whole foods "dietary patterns" such as a wide variety of fruits, vegetables, proteins, seafood, dairy and whole grains. During the partial feeding period (weeks 3-8), families will be asked to continue the whole foods diet with support that includes: 1) 3 weekly dinners of the families' choosing (described above), 2) rotating menus (\~3 weeks' worth) that will allow for customization (e.g., protein, vegetable, grain swaps) to support cultural/dietary preferences, and 3) dietetic support to help with customization and diet maintenance. Participants will be instructed by the registered dietitian nutritionist (RDN) on how to adhere to the diet intervention and will be provided menus and recipes. For the enrolled families in the study, the goal is to maintain complete diet adherence during the twelve-week intervention.

Study Details

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.

Key Dates

Start date
Oct 13, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Whole Foods Counseling Group (Control)
    Participants randomized to the control group will receive dietetic counseling sessions (weeks 1-2) on the 2020-2025 Dietary Guidelines for Americans (DGA) which is considered a healthy diet pattern for prediabetes. Diet adherence will be assessed with 3-day food diary in weeks 1-12. Study personnel and/or the study RDN will follow up with the participants during the study to review the food diaries.
  • Experimental: Whole Foods Healthy Eating Group (Intervention)
    The 12-week whole foods intervention consists of 2 phases. The feeding phase (weeks 1-8) is comprised of an intensive 2-week controlled feeding period followed by a 6-week partial feeding period. This diet intervention will encourage the consumption of a whole foods "dietary pattern". The maintenance phase (weeks 9-12) is a 4-week "free-living" period to assess intervention feasibility without food provision or dietetic support.

Primary Outcome Measure

Feasibility and acceptability [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University School of NursingNashvilleTennessee37240
Bryn Evans, MMHC, PMP
[email protected]
615-343-3290
Gay Nell Krauss, MPA, CRA
[email protected]
615-343 6070

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By research site
Vanderbilt University School of Nursing· Nashville, TN

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