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

NCT06482944 | Recruiting DMC

• 1 other identifier: 240761
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PreDiabetes; Diet, Healthy; Nutritional and Metabolic Diseases

Outcome Measures

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).

  12 weeks

Secondary Outcomes (10)

• Changes in adult Hemoglobin A1c (HbA1c) levels

  Baseline to 12-14 weeks

• Changes in adult and offspring diet quality

  Baseline to 12 weeks (assessed during study period)

• Change in Adult Body Mass Index (BMI)

  Baseline to 12 weeks

• Change in Offspring Body Mass Index (BMI) percentiles

  Baseline to 12 weeks

• Change in Offspring Body Mass Index (BMI) Z Scores

  Baseline to 12 weeks

Study Arms (2)

Whole Foods Counseling Group (Control)

NO INTERVENTION

Participants randomized to the control group will receive dietetic counseling sessions (weeks 1-2) on the 2020-2025 Dietary Guidelines for Americans (DGA) which is considered a healthy diet pattern for prediabetes. Diet adherence will be assessed with 3-day food diary in weeks 1-12. Study personnel and/or the study RDN will follow up with the participants during the study to review the food diaries.

Whole Foods Healthy Eating Group (Intervention)

EXPERIMENTAL

The 12-week whole foods intervention consists of 2 phases. The feeding phase (weeks 1-8) is comprised of an intensive 2-week controlled feeding period followed by a 6-week partial feeding period. This diet intervention will encourage the consumption of a whole foods "dietary pattern". The maintenance phase (weeks 9-12) is a 4-week "free-living" period to assess intervention feasibility without food provision or dietetic support.

Behavioral: Whole Foods for Families

Interventions

Whole Foods for Families BEHAVIORAL

This 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.

Whole Foods Healthy Eating Group (Intervention)

Eligibility Criteria

• Age: 6 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• For this study, eligible adults will be those that:
• 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;
• are English speaking;
• reside in Greater Nashville Tennessee and willing to come to Vanderbilt campus and Vanderbilt University Medical Center for required study visits;
• are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);
• are able to participate in a 12-week dietary program that requires home preparation/cooking for meals and snacks;
• For this study, eligible offspring will be those that:
• Are 6-18 years at time of initial screen;
• Have an index parent with prediabetes that is actively enrolled in the program;
• have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;
• have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
• have parental commitment to participate in a 12-week research study

You may not qualify if:

• 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;
• adults actively participating in any type of weight loss program (dietary or physical activity)
• adults with a prior history of type 2 diabetes;
• adults who are not English speaking or have limited English-language proficiency;
• adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
• adults with serious mental or neurologic illness that impairs the ability to consent/participate;
• women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;
• adults currently taking medications to treat diabetes or to promote weight loss;
• adults living outside Greater Nashville Tennessee or who are unwilling to travel to Vanderbilt for study visits;
• adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
• children/adolescents outside the specified age range of \<6 years or \>18 years;
• children/adolescents whose body mass index is \<5th percentile for age and gender on standardized CDC growth curves;

Sponsors & Collaborators

• Vanderbilt University: lead
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

Vanderbilt University School of Nursing

Nashville, Tennessee, 37240, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Nutritional and Metabolic Diseases

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nadia M Sneed, PhD, MSN

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia M. Sneed, PhD, MSN

CONTACT

615-343-1542; nadia.sneed@vanderbilt.edu

Kylee Vecchi, MS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study arms are, BY DESIGN, not able to be totally blinded. Investigators/data collection staff are blinded as to arm of an individual participant (collection staff will be blinded to the extent possible). Main outcome assessors are blinded as to the intervention the individual participant is receiving to the extent possible.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 1, 2024
• Study Start: October 13, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)