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

NCT05483972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-03-29

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Vanderbilt University

    lead OTHER

Principal Investigators

  • Nadia M Sneed, PhD, FNP-BC · Vanderbilt University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2023-03-22
Completion
2023-03-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05483972 on ClinicalTrials.gov