Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes

ConditionsPreDiabetes Diet, Healthy Nutritional and Metabolic Diseases

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-59

SponsorVanderbilt University

About this trial

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.

Eligibility criteria

Qualifiers

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;

have a body mass index of between ≥23kg/m2 to <40kg/m2;

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);

have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;

Disqualifiers

Adults who's HbA1c test is outside of the HbA1c range during screening* (see details related to screening results)

adults outside the specified age range of <25 years or >59 years;

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);

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;

Trial design

Treatments tested in this trial

Whole Foods for Families

Treatment groups

30 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Vanderbilt University

Lead sponsor

Vanderbilt University Medical Center

Collaborator

Source ClinicalTrials.gov