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NCT Number: NCT07509502

Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 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

Exclusion criteria

  • 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].

Treatment and study plan

Dietary Intervention Teaching Kitchen (TK) Classes

Behavioral

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

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.

Primary outcomes

  1. Changes in Healthy Eating Index Score

    Time frame: 4 weeks

    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)

  2. Changes in body weight

    Time frame: 4 weeks

    Changes in body weight

Study contacts

Contact information is provided by the study sponsor or research team.

Taylor Duncan

CONTACT

[email protected]

803-777-1214

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Registry information

Official study title

Building on the Dietary Guidelines: 3 Dietary Pattern (DG3D) Study - Testing a Teaching Kitchens and Food is Medicine Approach for Type 2 Diabetes Prevention

Acronym: OLIVE Pilot

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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