- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07509502
Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study (OLIVE Pilot)
Building on the Dietary Guidelines: 3 Dietary Pattern (DG3D) Study - Testing a Teaching Kitchens and Food is Medicine Approach for Type 2 Diabetes Prevention
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Taylor Duncan
- Phone Number: 803-777-1214
- Email: duncanta@mailbox.sc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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].
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: FiM only
Active control receiving weekly grocery delivery with no virtual teaching kitchen (TK) Mediterranean diet intervention
|
Participants will receive a delivery of up to $25 worth of grocery ingredients that support a Mediterranean diet each week for 4 weeks.
|
|
Experimental: FiM+TK
Virtual teaching kitchen (TK) Mediterranean diet intervention plus weekly grocery delivery
|
Participants will receive a delivery of up to $25 worth of grocery ingredients that support a Mediterranean diet each week for 4 weeks.
Participants will attend virtual classes once per week for 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Healthy Eating Index Score
Time Frame: 4 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)
|
4 weeks
|
|
Changes in body weight
Time Frame: 4 weeks
|
Changes in body weight
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Brie Turner-McGrievy, PhD, MS, RD, University of South Carolina
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000687
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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