Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Whole Foods for Families
BehavioralThis diet intervention will encourage the consumption of a whole foods "dietary patterns" such as a wide variety of fruits, vegetables, proteins, seafood, dairy and whole grains. During the partial feeding period (weeks 3-8), families will be asked to continue the whole foods diet with support that includes: 1) 3 weekly dinners of the families' choosing (described above), 2) rotating menus (\~3 weeks' worth) that will allow for customization (e.g., protein, vegetable, grain swaps) to support cultural/dietary preferences, and 3) dietetic support to help with customization and diet maintenance. Participants will be instructed by the registered dietitian nutritionist (RDN) on how to adhere to the diet intervention and will be provided menus and recipes. For the enrolled families in the study, the goal is to maintain complete diet adherence during the twelve-week intervention.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Whole Foods Counseling Group (Control)No intervention 0 interventions
Group B: Whole Foods Healthy Eating Group (Intervention)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
12 weeksSecondary outcomes
1
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.
Time frame
Baseline to 12-14 weeks2
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.
Time frame
Baseline to 12 weeks (assessed during study period)3
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.
Time frame
Baseline to 12 weeks4
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.
Time frame
Baseline to 12 weeksSponsors and contacts
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Vanderbilt University
Lead sponsor
Vanderbilt University Medical Center
Collaborator
Source ClinicalTrials.gov