RecruitingNot ApplicableNCT06482944

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

Sponsor

Vanderbilt University

Enrollment

30 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

Diet, Healthy Prediabetes Nutritional and Metabolic Diseases

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.

Eligibility

Min Age: 6 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a whole-food, diet-based intervention to prevent Type 2 diabetes in parents who have prediabetes. The program is family-based — it also includes healthy eating resources for their children — and is designed around the USDA Dietary Guidelines. **You may be eligible if...** - You are 25–59 years old and are a parent of at least one child aged 6–18 - Your BMI is between 23 and 40 - You have prediabetes confirmed by recent lab results (elevated blood sugar or HbA1c in the range of 5.7–6.4%) - You speak English - You have no major food allergies or dietary restrictions **You may NOT be eligible if...** - You already have Type 2 diabetes - You are pregnant - You have a serious medical condition that prevents dietary changes - You live more than a certain distance from the study site Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALWhole Foods for Families

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.