Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
NCT Number: NCT06482944
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: PreDiabetes|Diet, Healthy|Nutritional and Metabolic Diseases
Interventions: BEHAVIORAL: Whole Foods for Families
Sponsor: Vanderbilt University
Collaborators: Vanderbilt University Medical Center
Sex: ALL
Age: CHILD, ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-01
Completion Date: 2027-06-30
Locations: Vanderbilt University School of Nursing, Nashville, Tennessee, 37240, United States

Summary:
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.

Primary Outcome Measures: Feasibility and acceptability, Feasibility will be based on ≥80% participant retention and completion of outcome measures (e.g., HbA1c testing, anthropometry, surveys, diet checklists/recalls). Diet acceptability will be based on ≥75% adult diet satisfaction via survey report (using the acceptability measure)., 12 weeks
Secondary Outcome Measures: Changes in adult Hemoglobin A1c (HbA1c) levels, HbA1c will be collected in enrolled adults at baseline and 12-14 weeks by trained personnel at the VUSN laboratory using an HbA1c kit analyzed by A1c Now+ (PTS Diagnostics) which has been validated against venipuncture. This method will allow us to establish a clinically meaningful change in prediabetes status across 12 weeks using a minimally invasive alternative to laboratory-collected HbA1c or repeated glucose measures. HbA1c levels will need to be between 5.7%-6.4% per American Diabetes Association Classification Guidelines., Baseline to 12-14 weeks|Changes in adult and offspring diet quality, The 2020 Healthy Eating Index (HEI) will be used to estimate adult-offspring diet quality scores during the intervention. Scores will be calculated from 3-day food diaries imputed into NDSR software. The HEI uses a scoring system of 0-100 to determine how well an individual's diet (ages ≥2 years) aligns with major DGA recommendations with a higher diet quality score indicating a healthier diet. Dietary information from 3-day food diaries will be used to estimate the baseline diet quality score., Baseline to 12 weeks (assessed during study period)|Change in Adult Body Mass Index (BMI), Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese., Baseline to 12 weeks|Change in Offspring Body Mass Index (BMI) percentiles, Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI percentiles., Baseline to 12 weeks|Change in Offspring Body Mass Index (BMI) Z Scores, Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI z-scores., Baseline to 12 weeks|Change in Adult and Offspring Waist Measurements, Waist circumference will be measured in centimeters., Baseline to 12 weeks|Change in Diet adherence in adults and offspring, ≥80% compliance with the diet will be considered "adherent" and will be estimated qualitatively from food diaries in the intensive and maintenance phases. The dietitian will review food checklists/diaries to assess adherence and to modify diets or support compliance., Baseline to 12 weeks|Change in Offspring Weight, Weight will be measure in kilograms and will also be included in calculations to estimate BMI measures in kg/m\^2., Baseline to 12 weeks|Change in Adult Weight, Weight will be measure in kilograms and will also be included in calculations to estimate BMI measure kg/m\^2., Baseline to 8 weeks and 12 weeks|Change in Adult and Offspring Height, Height will be measured in meters and will also be included in calculations to estimate BMI measures kg/m\^2., Baseline to 12 weeks