30 Participants Needed

Whole Foods Diet for Prediabetes

NM
DS
Overseen ByDaien Sanchez, MA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Research suggests that consuming whole grains and fiber-rich foods is generally safe and may even offer health benefits, such as improved glucose control and reduced risk of developing type 2 diabetes.12567

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

NM

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

I have been diagnosed with prediabetes based on recent lab tests.
I can follow a 12-week diet plan that involves cooking at home.
My child can join a 12-week diet program with meals provided.
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Exclusion Criteria

Adults with serious mental or neurologic illness, pregnant or nursing, taking specific medications, or living outside Greater Nashville Tennessee
I am an adult managing prediabetes, participating in a weight loss program, or have a history of type 2 diabetes.
I am not between the ages of 25 and 59.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

8 weeks
Weekly check-ins (virtual or in-person)

Maintenance Phase

Participants enter a 4-week 'free-living' period to assess intervention feasibility without food provision or dietetic support

4 weeks
Bi-weekly follow-ups (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

  • Whole Foods for Families
Trial Overview The trial tests if a family-centered, non-calorie restricted whole foods diet can improve adults' HbA1c levels (a diabetes indicator) and enhance overall diet quality for both adults and children over 12 weeks compared to those not following this specific diet.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Whole Foods Healthy Eating Group (Intervention)Experimental Treatment1 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.
Group II: Whole Foods Counseling Group (Control)Active Control1 Intervention
Participants randomized to the control group will receive a single dietetic counseling session (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 a 7-day food diary in the first week and then a 3-day food diary in weeks 2-12. Study personnel and/or the study RDN will follow up with the participants during the study to review the food diaries.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University

Lead Sponsor

Trials
714
Recruited
6,143,000+

Vanderbilt University Medical Center

Collaborator

Trials
922
Recruited
939,000+

Findings from Research

Over half of the participants in a dietary survey in France reported never consuming whole grains, with those who did consuming very low amounts (9.1 g/d in children and 14.4 g/d in adults).
Whole grain consumers had higher intakes of fiber, vitamins, and minerals, and in adults, increased whole grain consumption was linked to a significant decrease in the odds of being overweight or obese.
Consumption of whole grains in French children, adolescents and adults.Bellisle, F., Hébel, P., Colin, J., et al.[2021]

References

Fiber-rich foods delivered to Low-Income Households: A feasibility study of children with prediabetes and spillover effect on their caregivers. [2022]
Epidemiological support for the protection of whole grains against diabetes. [2019]
The importance and effect of dietary fiber in diabetes prevention with particular consideration of whole grain products. [2022]
Glucose and insulin responses to whole grain breakfasts varying in soluble fiber, beta-glucan: a dose response study in obese women with increased risk for insulin resistance. [2021]
Consumption of whole grain reduces risk of deteriorating glucose tolerance, including progression to prediabetes. [2023]
Intake and sources of dietary fibre and dietary fibre fractions in Finnish children. [2023]
Consumption of whole grains in French children, adolescents and adults. [2021]
Dietary recommendations for children and adolescents with diabetes: an implementation paper. British Diabetic Association's Professional Advisory Committee. [2021]
A Narrative Review on Strategies for the Reversion of Prediabetes to Normoglycemia: Food Pyramid, Physical Activity, and Self-Monitoring Innovative Glucose Devices. [2023]
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