Clinical trial

Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07509502

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionType 2 Diabetes (T2DM), Obesity & Overweight

Full registry 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 \[ESP\].

Treatments and study arms

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

Changes in Healthy Eating Index Score4 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)

Changes in body weight4 weeks

Changes in body weight

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of South Carolina🇺🇸 Columbia, South Carolina, United States

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