Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study

ConditionsType 2 Diabetes (T2DM)Obesity & Overweight

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity of South Carolina

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: FiM onlyActive comparator 1 intervention

Group B: FiM+TKExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Time frame

4 weeks

Changes in body weight

Time frame

4 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Carolina

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: