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

Completed · Not applicable

Conditions studied: PreDiabetes

In brief

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.

Key facts

Study ID

NCT05483972

Run by

Vanderbilt University

People needed

20

Starts

2022-10-04

Expected to finish

2023-03-25

Last updated by the study team

2023-03-29

Who can join

Age: 25 and older, up to 59. Sex: any. Healthy volunteers: accepted.

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;
• are English speaking;
• reside within the greater Nashville, TN area and live at home with their index parent during duration of 2- week study;
• 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 includes at least dinner and snacks provided during after-school hours;

You may not qualify if…

• Adult exclusion criteria include:
• 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;
• Offspring (child[ren] and adolescent[s]) exclusion criteria include:
• 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;
• children/adolescents who do not have an eligible index parent participating in the study;
• children who do not have parental commitment to participate consistently for two-weeks;
• children/adolescents with a current or past diagnosis of diabetes mellitus (including prediabetes and type-2);
• children/adolescents who are not English speaking;
• children/adolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
• children/adolescents who display dissenting behaviors during baseline data collection;
• children/adolescents actively participating in any type of weight loss program (medical or lifestyle);
• children/adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;

Where it is running

• Vanderbilt University School of Nursing — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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