Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
Vanderbilt University
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.
Description
This dietary program is based on empirical evidence showing that a diet pattern that favors minimally processed and whole foods (e.g., whole grains, fruits, vegetables, nuts) in contrast to diet patterns with greater consumption of highly refined and ultra-processed foods are attributed to greater reductions in HbA1c and fasting plasma glucose and a reduced risk for T2D. This evidence comes primarily from prospective cohort and clinical studies of 1) adult populations without diabetes (including type 2 and pre-diabetes) and 2) adult populations with active T2D. Studies of family dietary interv…