Obesity & Overweight, Type 2 Diabetes (T2DM)
Conditions
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.
Interventions
BEHAVIORALDietary Intervention Teaching Kitchen (TK) Classes
Participants will attend virtual classes once per week for 4 weeks.
BEHAVIORALFood is Medicine Grocery Provision (FiM)
Participants will receive a delivery of up to $25 worth of grocery ingredients that support a Mediterranean diet each week for 4 weeks.
Sponsors
University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessors will be blinded to participant group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 \[ESP\].
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Healthy Eating Index Score | 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 | 4 weeks | Changes in body weight |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrie Turner-McGrievy, PhD, MS, RD
University of South Carolina
Outcome results
None listed