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

NCT05483972 | Completed

• 1 other identifier: 220475
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes

Outcome Measures

Primary Outcomes (6)

• Adult and offspring adherence to the diet program

  Adherence will be assessed by the number of days the National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) is completed to record dietary intake. The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool. ASA24 enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries.

  2 weeks

• Change in offspring diet quality pre-post intervention

  The Healthy Eating Index-2015 scale was calculated from collected 24-hour dietary recall data collected using the ASA24 (Automated-Self Administered Recall System) a computerized dietary assessment tool. Data was collected through Automated Self-Administered 24-hour dietary recall to calculate HEI-2015 scores. The scores range from 0 to 100, with higher scores reflecting greater adherence with dietary recommendations from the Dietary Guidelines for Americans. A score of 100 reflects high adherence and a score of 0 reflects no adherence.

  Baseline to two weeks

• Change in Adult Body Mass Index (BMI)

  Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese.

  Baseline to two weeks

• Change in Offspring Body Mass Index (BMI) percentiles

  Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI percentiles.

  Baseline to two weeks

• Change in Offspring Body Mass Index (BMI) Z Scores

  Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI z-scores.

  Baseline to two weeks

• Change in Adult and Offspring Waist Measurements

  Waist circumference will be measured in centimeters.

  Baseline to two weeks

Study Arms (1)

Whole Prediabetes Diet Intervention

EXPERIMENTAL

The diet intervention will consist of weekly food deliveries for a total of 2-weeks. The intervention will consist of a weekly individual counseling sessions led by the team's registered dietitian nutritionist (RDN). Prior to beginning the intervention, an initial individual and/or family meeting with the RDN will be scheduled. The focus of the meeting will be for the RDN to provide information about diet instruction, meal preparation/planning, and individual and family goal setting. Meetings can occur in person, via a secure zoom videoconference, or via telephone (per participant preference) and must take place with the index parent present, as they will be responsible for taking the lead of the diet intervention or relaying the information to the primary caregiver/spouse/partner in the household who is responsible for meal preparation/cooking. Child/adolescent participants will be instructed by the RDN on how to record their dietary intake (as age-appropriate) using a food diary.

Behavioral: Whole Prediabetes Diet Intervention

Interventions

Whole Prediabetes Diet Intervention BEHAVIORAL

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.

Whole Prediabetes Diet Intervention

Eligibility Criteria

• Age: 25 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For this study, eligible adults will be those that:
• are 25 to 59 years of age at time of initial screen and identify as a parent to at least one (two max) biological child or adolescent 6-17 years;
• have a body mass index of between ≥23kg/m2 to \<40kg/m2;
• have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg/dL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose during 75-g oral glucose tolerance test \[OGTT\] 140 mg/dL to 199 mg/dL) reported within the last 6 months and confirmed by the participants medical records;
• have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
• are English speaking;
• reside within the greater Nashville, TN area;
• are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);
• are able to participate in a two-week dietary program that requires home preparation/cooking for all meals and snacks;
• For this study, eligible offspring (child(ren)/ adolescent(s)) will be those that:
• Are 6-17 years at time of initial screen;
• Have an index parent with prediabetes that is actively enrolled in the program;
• have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;
• have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
• have parental commitment to participate in a two-week research study;

You may not qualify if:

• adults outside the specified age range of \<25 years or \>59 years;
• adults whose body mass index is \<23kg/m2 or those with a body mass index ≥40kg/m2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss);
• are not currently undergoing routine medical supervision by a licensed healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or frequent healthcare visits for management/treatment;
• adults actively participating in any type of weight loss program (dietary or physical activity) or those who participate in regular (≥120 minutes per week) moderate to vigorous physical activity (as requirements of the program include assessing weight change as a result of the diet);
• adults with a prior history of type 2 diabetes;
• adults who are not English speaking;
• adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
• adults with serious mental or neurologic illness that impairs ability to consent/participate;
• women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;
• adults currently taking medications to treat diabetes or to promote weight loss;
• adults living outside the greater Nashville, TN area;
• adults with poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener);
• adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
• children/adolescents outside the specified age range of \<6 years or \>17 years;
• children/adolescents whose body mass index is \<5th percentile for age and gender on standardized CDC growth curves;

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37240, United States

Location

Related Publications (1)

• Sneed NM, Kelley R, Turner H, Piano MR, Dagostino C, Sellers A, Bonnet K, Schlundt D, Adams LE, Heerman WJ. The development and testing of a single-arm feasibility and acceptability study of a whole foods diet intervention for adults with prediabetes and their offspring. Pilot Feasibility Stud. 2024 Oct 23;10(1):130. doi: 10.1186/s40814-024-01554-9.

  PMID: 39444044 DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nadia M Sneed, PhD, FNP-BC

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: August 2, 2022
• Study Start: October 4, 2022
• Primary Completion: March 22, 2023
• Study Completion: March 25, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)