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-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet. Feasibility: ≥80% participant retention and completion of study outcome measures. Acceptability: ≥75 adult diet satisfaction via survey report and/or perceived diet satisfaction via focus groups. 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/child diet quality during the 12-week intervention. Aim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes. Hypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group. Aim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group. 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 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 child or adolescent 6-18 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) 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);
• 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 6-18 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);
• are able to participate in a 12-week dietary program that includes at least dinner and snacks provided during after-school hours;