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

Launched by VANDERBILT UNIVERSITY · Jun 25, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Whole Food for Families," is looking at how a healthy, whole foods diet can help prevent type 2 diabetes, especially in families. The study will include adult-child pairs, where the adult has prediabetes, and they will follow a 12-week eating plan that focuses on whole foods without counting calories. The researchers want to see if this diet is acceptable to participants and whether it can improve health markers like blood sugar levels in adults and overall diet quality for both adults and children.

To be eligible, adults need to be between 25 and 59 years old, live with at least one child aged 6 to 18, and have a body mass index (BMI) between 23 and 40. They should also have prediabetes and be able to prepare meals at home. Children must be within the age range, have a parent participating in the study, and have a healthy BMI. Participants will come to Vanderbilt University Medical Center for study visits, and they can expect to learn more about healthy eating while working together as a family. This trial is not yet recruiting, but it aims to create a supportive environment for families to improve their health.

Gender

ALL

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;