Clinical trial for PreDiabetes
Official title Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
ClinicalTrials.gov ID: NCT06482944
What this study is testing
- What it's testing
- To see if a family‑centered, non‑calorie‑restricted whole foods diet can be followed for 12 weeks and whether it lowers adults' blood sugar (HbA1c) and improves diet quality for both adults and children.
- Who it's for
- Adults who have prediabetes and one of their children who live with them.
- What's involved
- Participants will eat a whole‑foods diet without counting calories for 12 weeks, attend study visits for blood tests and surveys, and may join focus‑group discussions about diet challenges.
- Time commitment
- The study lasts about 12 weeks and includes baseline and follow‑up visits plus periodic surveys and possible focus‑group sessions.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 59
You may be able to join if
- 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...
- 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...
- have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
- are English speaking;
You likely can't join if
- 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 \ 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...
- receiving care by a healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or...
- adults actively participating in any type of weight loss program (dietary or physical activity)
- adults with a prior history of type 2 diabetes;
See the full eligibility criteria
Who can join
- 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...
- 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 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 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
What rules you out
- 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 \ 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...
- 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;
- offspring outside the specified age range of \ 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;
- 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);
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.