Dietary Intervention Teaching Kitchen (TK) Classes / Obesity & Overweight / Food is Medicine Grocery Provision (FiM) · Interventional Study

Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study

ClinicalTrials.gov · August 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned pilot RCT comparing a combined intervention (grocery provision plus nutrition classes) to grocery provision alone over 4 weeks in adults with type 2 diabetes or obesity in the US South. No results have been reported in this registry record; the study is registered but outcomes are not yet available.

What was studied

Interventional, Randomized, Parallel, Single masking, Prevention purpose. Type 2 Diabetes (T2DM), Obesity & Overweight; age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: FiM+TK. Compared with: FiM only — Active Comparator. n = 40. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

If completed as registered, this pilot will provide preliminary evidence on whether adding nutrition education to food provision improves diet quality and weight outcomes in southern US populations with metabolic disease. Results remain unavailable and should not be anticipated from this registry entry.

Plain-language summary

This is a pilot RCT with planned enrollment of 40 participants and a 4-week follow-up examining surrogate endpoints (diet quality and body weight); results are not yet reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Changes in Healthy Eating Index Score (assessed at 4 weeks); Changes in body weight (assessed at 4 weeks)

DesignInterventional, Randomized, Parallel, Single masking, Prevention purpose

PopulationType 2 Diabetes (T2DM), Obesity & Overweight; age from 18 Years; to 65 Years; accepts healthy volunteers

Sample size40

InterventionFiM+TK

ComparatorFiM only — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment40

Study duration4 weeks

Primary outcome measure 1Changes in Healthy Eating Index Score

Primary outcome measure 2Changes in body weight

Clinical bottom line

Caveats

No results are reported in this registry record; study is registered but outcome data have not been posted.
Pilot design with small planned sample (40) limits power to detect clinically meaningful differences.
Follow-up limited to 4 weeks; longer-term sustainability of dietary and weight changes unknown.
Blinding, randomization method, and detailed eligibility criteria not described in registry summary.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized controlled trial design with two arms, but pilot-phase with small planned sample.

Directness

moderate

Surrogate endpoints (HEI score, body weight) rather than clinical hard outcomes in T2DM.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Randomization method, blinding status, and outcome assessment details not described in registry.

Sample adequacy

limited

Estimated enrollment 40 participants; pilot study not powered for definitive conclusions.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07509502). This is a study registration, not published results. Lead sponsor: University of South Carolina. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Type 2 Diabetes (T2DM), Obesity & Overweight. Interventions: BEHAVIORAL: Dietary Intervention Teaching Kitchen (TK) Classes; BEHAVIORAL: Food is Medicine Grocery Provision (FiM). Primary outcome measures: Changes in Healthy Eating Index Score , 4 weeks; Changes in body weight , 4 weeks. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Dietary Intervention Teaching Kitchen (TK) ClassesObesity & OverweightFood is Medicine Grocery Provision (FiM)Type 2 Diabetes (T2DM)NCT07509502University of South Carolina