Actively Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
Led by Vanderbilt University · Updated on 2026-03-06
30
Participants Needed
1
Research Sites
89 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University
Lead Sponsor
V
Vanderbilt University Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 25 to 59 years who are parents of a child or adolescent aged 6 to 18 years
- Adults with a body mass index between 23 kg/m2 and less than 40 kg/m2
- Adults with prediabetes confirmed by recent lab values and HbA1c test before enrollment
- Adults without special dietary restrictions or food allergies prohibiting varied food consumption
- Adults who speak English
- Adults residing in Greater Nashville Tennessee and willing to attend Vanderbilt study visits
- Adults without medical conditions limiting diet-related study participation (e.g., tube feeding, severe food allergy)
- Adults able to participate in a 12-week home meal preparation and cooking program
- Children aged 6 to 18 years at initial screening
- Children with an index parent enrolled in the program
- Children with body mass index at or above the 5th percentile for age and gender
- Children without special dietary restrictions or food allergies prohibiting varied food consumption
- Children with parental commitment to participate for 12 weeks
- Children who speak English
- Children residing in Greater Nashville Tennessee and living at home with the enrolled parent
- Children without medical conditions limiting diet-related study participation
- Children able to participate in a 12-week dietary program including provided dinners and snacks
You will not qualify if you...
- Adults with HbA1c test results outside the specified range during screening
- Adults younger than 25 years or older than 59 years
- Adults with body mass index less than 23 kg/m2 or 40 kg/m2 and above
- Adults receiving care for complicated prediabetes requiring frequent monitoring
- Adults currently in any weight loss program
- Adults with a prior diagnosis of type 2 diabetes
- Adults who do not speak English or have limited English proficiency
- Adults with dietary restrictions, food allergies, or medical conditions prohibiting diet study participation
- Adults with serious mental or neurological illness affecting consent or participation
- Pregnant or nursing women
- Adults taking medications for diabetes or weight loss
- Adults living outside Greater Nashville Tennessee or unwilling to travel for visits
- Adults not meeting other eligibility criteria as determined by pre-screen
- Children younger than 6 years or older than 18 years
- Children with body mass index below the 5th percentile for age and gender
- Children without an eligible enrolled parent
- Children without parental commitment to participate
- Children who do not speak English or have limited English proficiency
- Children with dietary restrictions, food allergies, or medical conditions prohibiting diet study participation
- Children showing dissenting behaviors during baseline data collection
- Children actively participating in any weight loss program
- Children not meeting other eligibility criteria as determined by pre-screen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University School of Nursing
Nashville, Tennessee, United States, 37240
Actively Recruiting
Research Team
N
Nadia M. Sneed, PhD, MSN
CONTACT
K
Kylee Vecchi, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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