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

Summary

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.

Eligibility

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;

Conditions4

Locations1 site

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