Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study

NCT07509502 | Not Yet Recruiting

• 1 other identifier: STUDY00000687
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this pilot clinical trial is to examine how receipt of ingredients for a Mediterranean diet (with or without nutrition classes) impacts Type 2 Diabetes Mellitus risk factors among adults in the US South. The main question it aims to answer is: \- Will greater improvements in diet quality (HEI Score) and body weight be seen in the group that receives grocery delivery and nutrition classes (TK+FiM) compared to the group receiving grocery delivery only (FiM only)? Researchers will evaluate the changes in diet quality and body weight among participants in each group to see which group experiences greater improvements. Participants will:

• be randomly assigned to either receive weekly grocery deliveries and attend weekly virtual nutrition classes for 4 weeks or receive weekly grocery deliveries only.
• be asked to complete surveys/questionnaires at the baseline and 4-week timepoints in the study.
• be asked to participate in a post-study focus group to talk about their experiences during the intervention.

Conditions

Type 2 Diabetes (T2DM); Obesity & Overweight

Outcome Measures

Primary Outcomes (2)

• Changes in Healthy Eating Index Score

  Changes in dietary quality as assessed by the Healthy Eating Index (HEI-2020; scale range 0-100 where a higher score means better dietary quality)

  4 weeks

• Changes in body weight

  Changes in body weight

  4 weeks

Study Arms (2)

FiM only

ACTIVE COMPARATOR

Active control receiving weekly grocery delivery with no virtual teaching kitchen (TK) Mediterranean diet intervention

Behavioral: Food is Medicine Grocery Provision (FiM)

FiM+TK

EXPERIMENTAL

Virtual teaching kitchen (TK) Mediterranean diet intervention plus weekly grocery delivery

Behavioral: Dietary Intervention Teaching Kitchen (TK) Classes; Behavioral: Food is Medicine Grocery Provision (FiM)

Interventions

Dietary Intervention Teaching Kitchen (TK) Classes BEHAVIORAL

Participants will attend virtual classes once per week for 4 weeks.

FiM+TK

Food is Medicine Grocery Provision (FiM) BEHAVIORAL

Participants will receive a delivery of up to $25 worth of grocery ingredients that support a Mediterranean diet each week for 4 weeks.

FiM only; FiM+TK

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• BMI between 25- 49.9 kg/m2
• Live in a southern state (as classified by the US Census)
• Be able to complete all survey assessments via computer or phone
• Have a wi-fi connection at home or other site to access Zoom-delivered interventions
• Have three or more type 2 diabetes risk factors (NIDDK Risk factors for T2DM)
• Own a digital body weight scale, have regular access, or be willing to purchase one

You may not qualify if:

• Currently participating in a weight loss program or taking weight loss medications
• Has lost more than 10 pounds in the past 6 months
• Diagnosed with major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, diabetes, or pregnancy
• Pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 3 months, or currently breastfeeding
• Diagnosed with an eating disorder as screened by the Eating disorder Screen for Primary care \[ESP\].

Sponsors & Collaborators

• University of South Carolina: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Overweight

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Brie Turner-McGrievy, PhD, MS, RD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taylor Duncan

CONTACT

803-777-1214; duncanta@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to participant group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: April 3, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04