Whole Food for Families: a family whole-foods diet program to prevent type 2 diabetes

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

This pilot randomized program will test whether a 12-week, family-centered, non-calorie-restricted whole-foods diet for parents with prediabetes and their children lowers adult HbA1c and improves family diet quality.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 6 Years to 59 Years
• Sex: All
• Sponsor: Vanderbilt University (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT06482944 on ClinicalTrials.gov

What this trial studies

This pilot randomized controlled trial will enroll adult–child pairs and randomly assign families to a 12-week, non‑calorie‑restricted whole‑foods program based on the Dietary Guidelines for Americans or to a control condition. The trial will test feasibility and acceptability by measuring enrollment, retention (target ≥80%), and adult diet satisfaction (target ≥75%). It will also test preliminary effectiveness on adult HbA1c at 12 weeks and on adult and child diet quality using the 2020 Healthy Eating Index. Eligible adults are 25–59 years old with BMI 23–<40, confirmed prediabetes, no prohibitive dietary restrictions, English-speaking, and willing to attend visits at Vanderbilt in Greater Nashville.

Who should consider this trial

Good fit: Ideal candidates are English-speaking parents aged 25–59 with BMI 23–<40 and confirmed prediabetes who have at least one child aged 6–18, no restrictive food allergies, and who can attend Vanderbilt visits in Greater Nashville.

Not a fit: People with diagnosed diabetes, major medical conditions that limit participation, restrictive diets or food allergies, non-English speakers, or those living outside the Greater Nashville area likely would not benefit or be eligible.

Why it matters

Potential benefit: If successful, the program could lower adult blood sugar (HbA1c) and improve diet quality in parents and children, reducing future risk of type 2 diabetes.

How similar studies have performed: Previous adult-focused trials of Mediterranean, DASH, and other whole-food patterns have shown improvements in glycemia, but family-based interventions using the Dietary Guidelines for Americans are novel and less tested.

Eligibility criteria

Inclusion Criteria:

For this study, eligible adults will be those that:

1. are 25 to 59 years of age at time of initial screen and identify as a parent to at least one child or adolescent 6-18 years;
2. have a body mass index of between ≥23kg/m2 to \<40kg/m2;
3. 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);
4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
5. are English speaking;
6. reside in Greater Nashville Tennessee and willing to come to Vanderbilt campus and Vanderbilt University Medical Center for required study visits;
7. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);
8. 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:

1. Are 6-18 years at time of initial screen;
2. Have an index parent with prediabetes that is actively enrolled in the program;
3. have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;
4. have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
5. have parental commitment to participate in a 12-week research study
6. are English speaking;
7. reside in the Greater Nashville Tennessee area and live at home with their index parent during the duration of 12- week study;
8. are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);
9. are able to participate in a 12-week dietary program that includes at least dinner and snacks provided during after-school hours;

Exclusion Criteria:

Adult exclusion criteria include:

1. Adults who's HbA1c test is outside of the HbA1c range during screening\* (see details related to screening results)
2. adults outside the specified age range of \<25 years or \>59 years;
3. 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);
4. 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;
5. adults actively participating in any type of weight loss program (dietary or physical activity)
6. adults with a prior history of type 2 diabetes;
7. adults who are not English speaking or have limited English-language proficiency;
8. adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
9. adults with serious mental or neurologic illness that impairs the ability to consent/participate;
10. women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;
11. adults currently taking medications to treat diabetes or to promote weight loss;
12. adults living outside Greater Nashville Tennessee or who are unwilling to travel to Vanderbilt for study visits;
13. 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:

1. children/adolescents outside the specified age range of \<6 years or \>18 years;
2. children/adolescents whose body mass index is \<5th percentile for age and gender on standardized CDC growth curves;
3. children/adolescents who do not have an eligible index parent participating in the study;
4. children who do not have parental commitment to participate consistently for 12-weeks
5. children/adolescents who are not English speaking or have limited English-language proficiency;
6. children/adolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
7. children/adolescents who display dissenting behaviors during baseline data collection;
8. children/adolescents actively participating in any type of weight loss program (medical or lifestyle);
9. children/adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;

Where this trial is running

Nashville, Tennessee

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

Study contacts

• Principal investigator: Nadia M Sneed, PhD, MSN — Vanderbilt University
• Study coordinator: Nadia M. Sneed, PhD, MSN

Conditions PreDiabetes; Diet, Healthy; Nutritional and Metabolic Diseases