Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study (NCT07509502) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study
40 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \[ESP\].
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.