Family diet study aims to stop diabetes before it starts
NCT ID NCT06482944
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether a 12-week family-centered, non-calorie restricted whole foods diet can help prevent type 2 diabetes in adults with prediabetes. About 30 adult-child pairs will participate, with adults having prediabetes and children aged 6-18. The study measures feasibility, diet satisfaction, and changes in blood sugar levels.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 59 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Vanderbilt University School of Nursing
RECRUITINGNashville, Tennessee, 37240, United States
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