Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Years to 59 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Acceptability: ≥75 adult diet satisfaction via survey report and/or perceived diet satisfaction via focus groups."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This 12-week study tests a family whole-food eating plan with no calorie limit for parents with prediabetes and their children. Prediabetes means blood sugar is higher than normal but not in the diabetes range. The study checks whether families can follow and like the plan, whether parents’ blood sugar improves, and whether families eat healthier.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Parents must be ages 25–59 and join with a child ages 6–18.
- Parents must have a BMI from 23 to less than 40. BMI is a measure of weight compared with height.
- Parents must have prediabetes shown by lab tests from the past 6–12 months and confirmed by a blood sugar test before joining.
- Children must have a BMI at or above the 5th percentile on growth charts for their age and sex.
- Parents and children must speak English and live in Greater Nashville, Tennessee. Parents must be willing to travel to Vanderbilt for study visits.
- Children must live with their enrolled parent during the study and have a parent committed to taking part for all 12 weeks.
- Families must be able to follow the 12-week food plan, including cooking meals and snacks at home. Children must be able to take part in at least dinner and after-school snacks.
- Parents and children must be able to eat a variety of foods and drinks, without food restrictions, allergies, or health problems that prevent taking part.
Who can't join
- Parents whose screening HbA1c is outside the required range. HbA1c is a blood test that measures average blood sugar.
- Parents with past type 2 diabetes or prediabetes that needs regular blood sugar checks or frequent medical visits.
- Parents taking medicine to treat diabetes or help with weight loss.
- Parents or children who are taking part in a weight-loss program.
- Parents who are pregnant or breastfeeding.
- Parents with a serious mental health or brain or nerve illness that limits their ability to agree to or take part in the study.
- Children who show that they do not want to take part during the first study measurements.
- Parents or children who do not meet the other age, BMI, language, location, health, or participation rules.
Simplified for readability. The official criteria below are what the study team uses.
Official 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;
Study sites (1)
TN
- Vanderbilt University School of Nursing · Nashville, TN 37240Bryn Evans, MMHC, PMP · Study contact · 615-343-3290 · bryn.evans@vanderbilt.eduGay Nell Krauss, MPA, CRA · Study contact · 615-343 6070 · gaynell.krauss@Vanderbilt.EduMore trials in Nashville