BridgeMD
New treatment option 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
- 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.
- Which group you join is decided by chance.
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
- 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...
- have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
You likely can't join if
- Adult exclusion criteria include:
- Adults who's HbA1c test is outside of the HbA1c range during screening\ (see details related to screening results)
- adults outside the specified age range of \ 59 years;
- 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...
- 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)
See the full eligibility criteria
Who can join
- 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...
- 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;
What rules you out
- Adult exclusion criteria include:
- Adults who's HbA1c test is outside of the HbA1c range during screening\ (see details related to screening results)
- adults outside the specified age range of \ 59 years;
- 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...
- 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;
- 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:
- children/adolescents outside the specified age range of \ 18 years;
- children/adolescents whose body mass index is \<5th percentile for age and gender on standardized CDC growth curves;
- children/adolescents who do not have an eligible index parent participating in the study;
- children who do not have parental commitment to participate consistently for 12-weeks
- children/adolescents who are not English speaking or have limited English-language proficiency;
- children/adolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
- children/adolescents who display dissenting behaviors during baseline data collection;
- children/adolescents actively participating in any type of weight loss program (medical or lifestyle);
- children/adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.