Whole foods diet for families to help prevent type 2 diabetes

Trial details

Who runs it

Vanderbilt University

Trial code

NCT06482944

Record updated

2 November 2026

Original description

This study will address the following aims:Read full original descriptionShow less

Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes

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-offspring pairs or adult-spouse/significant other pairs after a 12-week family-centered, non-calorie restricted whole foods diet.

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/offspring or adult/spouse or significant other diet quality during the 12-week intervention.

Aim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes.

Aim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and offspring.

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.

For this study, eligible adults with prediabetes 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 offspring 6-26 years or identify as a spouse/partner to an adult 25-64 years; have a body mass index of between ≥23kg/m2 to ≤45kg/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) with recent lab values reported within the prior 6-12 months and confirmed by an HbA1c A1cNow+ collected prior to enrollment (*see comment below); have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages; are English speaking; reside in Greater Nashville Tennessee and willing to come to Vanderbilt campus and Vanderbilt University Medical Center for required study visits; are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis; history of or active eating disorder); are able to participate in a 12-week dietary program that requires home preparation/cooking for meals and snacks; For this study, eligible offspring will be those that:; Are 6-26 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 12-week research study; are English speaking; reside in the Greater Nashville Tennessee area and live at home with their index parent during the duration of 12- 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, history or active eating disorder); are able to participate in a 12-week dietary program that includes at least dinner and snacks provided during after-school hours; For this study, eligible spouse/partner will be those that:; Are 25-64 years at time of initial screen; Be considered a spouse/partner of an adult with prediabetes that is actively enrolled in the program; have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages; are English speaking; reside in the Greater Nashville Tennessee area and live in the home of the enrolled adult with prediabetes during the duration of 12- 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, history or active eating disorder); Adult with prediabetes exclusion criteria include:; Adults whose HbA1c test is outside of the HbA1c range during screening* (see details related to screening results); adults outside the specified age range of <25 years or >64 years; adults whose body mass index is <23kg/m2 or those with a body mass index ≥46kg/m2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss); receiving care by a 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); adults with a prior history of type 2 diabetes; adults who are not English speaking or have limited English-language proficiency; 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 the 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 Greater Nashville Tennessee or who are unwilling to travel to Vanderbilt for study visits; adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen; Offspring exclusion criteria include:; offspring outside the specified age range of <6 years or >26 years; offspring (under 18 years) whose body mass index is <5th percentile for age and gender on standardized CDC growth curves; offspring who do not have an eligible index parent participating in the study; children (under 18 years) who do not have parental commitment to participate consistently for 12-weeks; offspring who are not English speaking or have limited English-language proficiency; offspring with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study; offspring with active or history of eating disorder; children/adolescents (under 18 years) who display dissenting behaviors during baseline data collection; offspring who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen; Spouse/partner exclusion criteria include:; Spouse/partner outside the specified age range <25 year or ≥65 years; Does not identify as a spouse/partner of the adult with prediabetes that plans to be enrolled in the program; Spouse/partner with special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages; Spouse/partner who are not English speaking or have limited English-language proficiency; Spouse/partner who does not reside in the Greater Nashville Tennessee area and/or does not live in the home of the enrolled adult with prediabetes during the duration of 12- week study; Spouse/partner with medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis, history or active eating disorder).

ClinicalTrials.gov NCT06482944