Optimizing Lifestyles Through Increased Vegetable-rich Eating Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dietary Intervention Teaching Kitchen (TK) Classes, Food is Medicine Grocery Provision (FiM).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes (T2DM), Obesity & Overweight. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
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
- Behavioral Dietary Intervention Teaching Kitchen (TK) Classes
Participants will attend virtual classes once per week for 4 weeks. - Behavioral Food 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.
Primary outcome measures
- Changes in Healthy Eating Index Score [Time frame: 4 weeks]
- Changes in body weight [Time frame: 4 weeks]
Eligibility 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 \[ESP\].
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07509502 · STUDY00000687