Optimizing Lifestyles Through Increased Vegetable-rich Ea... | NCT07509502

Studies
Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study

NCT07509502

Sponsor

University of South Carolina

Status

Not yet recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Type 2 Diabetes (T2DM)
Obesity & Overweight

Interventions

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

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2027Estimated

First Submitted Date

Mar 25, 2026

First Submission Date that Met QC Criteria

Mar 30, 2026

First Posted Date

Apr 3, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2026

Last Update Posted Date

Apr 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Dietary Intervention Teaching Kitchen (TK) Classes	Behavioral	Participants will attend virtual classes once per week for 4 weeks.	FiM+TK

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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].

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Taylor Duncan	Contact	803-777-1214		duncanta@mailbox.sc.edu

Overall Officials

Name	Affiliation	Role
Brie Turner-McGrievy, PhD, MS, RD	University of South Carolina	Principal Investigator

Locations

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Mar 30, 2026	Apr 6, 2026	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D009765	Obesity
D050177	Overweight

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided