Building on the Dietary Guidelines: 3 Dietary Pattern (DG3D) Study - Testing a Teaching Kitchens and Food is Medicine Approach for Type 2 Diabetes Prevention
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of South Carolina
- Enrollment
- 40
- Primary Endpoint
- Changes in Healthy Eating Index Score
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Assessors will be blinded to participant group.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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 \[ESP\].
Arms & Interventions
FiM only
Active control receiving weekly grocery delivery with no virtual teaching kitchen (TK) Mediterranean diet intervention
Intervention: Food is Medicine Grocery Provision (FiM) (Behavioral)
FiM+TK
Virtual teaching kitchen (TK) Mediterranean diet intervention plus weekly grocery delivery
Intervention: Dietary Intervention Teaching Kitchen (TK) Classes (Behavioral)
FiM+TK
Virtual teaching kitchen (TK) Mediterranean diet intervention plus weekly grocery delivery
Intervention: Food is Medicine Grocery Provision (FiM) (Behavioral)
Outcomes
Primary Outcomes
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)
Changes in body weight
Time Frame: 4 weeks
Changes in body weight
Secondary Outcomes
No secondary outcomes reported
Investigators
Brie Turner-McGrievy
Professor
University of South Carolina