Whole Foods Diet for Prediabetes
Trial Summary
Will I have to stop taking my current medications?
The trial requires that adults not be taking medications to treat diabetes or promote weight loss. If you are on such medications, you would need to stop taking them to participate.
What data supports the effectiveness of the Whole Foods for Families treatment for prediabetes?
Research shows that eating whole grains, which are part of a whole foods diet, can lower the risk of developing type 2 diabetes and improve blood sugar control. High intake of dietary fiber, found in whole grains, fruits, and vegetables, is linked to better weight management and reduced risk of diabetes.12345
Is a whole foods diet safe for people with prediabetes?
How does the Whole Foods for Families treatment differ from other treatments for prediabetes?
The Whole Foods for Families treatment is unique because it focuses on a diet rich in whole grains and dietary fiber, which can improve glucose control and reduce the risk of developing type 2 diabetes. Unlike other treatments that may involve medication, this approach emphasizes accessible dietary changes, particularly beneficial for low-income households.12389
What is the purpose of this trial?
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.
Research Team
Nadia M Sneed, PhD, MSN
Principal Investigator
Vanderbilt University
Eligibility Criteria
This trial is for adult-child pairs where the adult has prediabetes. They should be willing to follow a whole foods diet without calorie restrictions and participate in surveys or focus groups. The study aims to keep at least 80% of participants until the end and achieve high satisfaction with the diet.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Feeding Phase
Participants undergo an intensive 2-week controlled feeding period followed by a 6-week partial feeding period focusing on a whole foods dietary pattern
Maintenance Phase
Participants enter a 4-week 'free-living' period to assess intervention feasibility without food provision or dietetic support
Follow-up
Participants are monitored for safety and effectiveness after the intervention
Treatment Details
Interventions
- Whole Foods for Families
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University
Lead Sponsor
Vanderbilt University Medical Center
Collaborator