NCT05483972

Whole Prediabetes: A Family-Centered Whole Foods Diet in Adults With Prediabetes and Their Offspring

Whole Prediabetes: A Precision Nutrition Approach to Test the Feasibility of Delivering a Family-Centered Whole Foods Diet in Adults With Prediabetes and Their Offspring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 25 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study will address the following aims: Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring (6-17 years). Aim 2: Test the feasibility, acceptability, enrollment, retention, and completion rates of a 2-week family-centered whole foods-based diet for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring 6-17 years. Aim 3: Estimate and compare differences in baseline and 2-week body mass change (e.g., BMI, BMI percentiles and Z-scores, waist circumference) and diet quality for the index parent and their enrolled biological offspring.

Detailed description

This dietary program is based on empirical evidence showing that a diet pattern that favors minimally processed and whole foods (e.g., whole grains, fruits, vegetables, nuts) in contrast to diet patterns with greater consumption of highly refined and ultra-processed foods are attributed to greater reductions in HbA1c and fasting plasma glucose and a reduced risk for T2D. This evidence comes primarily from prospective cohort and clinical studies of 1) adult populations without diabetes (including type 2 and pre-diabetes) and 2) adult populations with active T2D. Studies of family dietary interventions for transgenerational T2D prevention are lacking. Studies have focused primarily on structured diet patterns such as the Mediterranean style, Vegetarian or Vegan, Dietary Approaches to Stop Hypertension (DASH), carbohydrate-restricted, and low-fat. Evidence supports that the diet patterns most effective for T2D risk reduction focused on primarily whole food consumption (e.g., Mediterranean-style, Vegetarian, and DASH). Yet, less attention has been given to studying the effectiveness of the Dietary Guidelines for American's (DGA) diet pattern which forms the basis of nutrition advice in the U.S. and is the guiding nutrition framework used for federal nutrition policy. Moreover, a benefit of the recent DGA is its customizable approach to diet. Recognizing the importance of a whole foods structured diet and the recent shift of the Dietary Guidelines for American's DGA diet pattern towards a customizable, family-centered, whole foods approach, studies that test the effectiveness of a DGA-structured diet for T2D risk reduction should be prioritized. Before conducting efficacy and effectiveness trails, pilot data is needed to determine the feasibility and acceptability of using this family-centered diet approach in a population at "high risk" for T2D. Applying a family-lens where a transgenerational approach can be used to prevent T2D is necessary. Therefore, this program aims are to design and test the feasibility of delivering a whole foods diet pattern using a family centered approach in a population at risk for T2D- adults with prediabetes and their "at-risk" biological offspring.

Conditions

• PreDiabetes

Interventions

Type	Name	Description
BEHAVIORAL	Whole Prediabetes Diet Intervention	Participants will be instructed by RDN on how to adhere to the diet intervention and will be provided menus and recipes. For the enrolled adults in the study, the goal is to maintain complete diet adherence during the two-week intervention. The focus for children/adolescents will be on encouragement and exposure of the diet by the index parent and any additional household parent/guardian/caregiver. Participants will receive groceries that are tailored specifically to the prescribed diet menus/recipes for each week. Foods will be distributed using either a grocery delivery service or via participant pick-up. Each household will receive enough groceries to feed a household of four-persons for each week of the intervention.

Timeline

• Start date: 2022-10-04
• Primary completion: 2023-03-22
• Completion: 2023-03-25
• First posted: 2022-08-02
• Last updated: 2023-03-29

Locations

1 site across 1 country: United States