Pilot Trial of the Nutrition-Supported Diabetes Education Program
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
This is a pragmatic, pilot randomized controlled trial (RCT) of the Nutrition-Supported Diabetes Education Program (NU-DSMP). This study will test the feasibility and preliminary impact of providing diabetes-tailored food support and individualized case-management on glycemic control and other intermediate outcomes including food security, diet, mental health, and health care behaviors, among Medicaid-enrolled patients with type 2 diabetes in a safety-net county health system.
Key facts
- Study ID
- NCT05067452
- Run by
- University of California, San Francisco
- People needed
- 36
- Starts
- 2021-11-08
- Expected to finish
- 2023-08-16
- Last updated by the study team
- 2025-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of type 2 diabetes mellitus (T2DM) in the medical record
- Most recent HbA1c (within 1 year) ≥ 7%
- Receives primary care for diabetes from Contra Costa Health Services
- Is a current member of Contra Costa Health Plan
- Age ≥18 years
- Has an HbA1c test in the medical record in the last month; OR their doctor has an active order for an HbA1c test for the potential participant; OR the participant is eligible to have a test ordered as part of usual care
- Speaks English or Spanish
- Adequate cognitive and hearing capacity to complete study measures
- Willing to participate in the online or telephone DSMP education, and if randomized to the intervention, to receive home-delivered meals and groceries
- Has the ability to engage with simple reading materials (e.g. directions to join the education session by phone or Zoom) on their own or with the support of a family member or friend
- Has access to a device (telephone, tablet, and/or computer) that can be used to receive remote DSMP education (possible via phone, computer or tablet) and complete study assessments (phone only; or tablet or computer with phone capabilities) (does not need to be participant's own device)
You may not qualify if…
- Currently pregnant at baseline, currently breastfeeding, up to 6 months postpartum, or plans to become pregnant during the course of the study. If participant becomes pregnant during the study, services provided as part of the study won't stop, however, data will not be used in the main analysis
- Has confirmed Type 1 DM
- Has confirmed stage 5 chronic kidney disease, end stage renal disease or is on dialysis or expected to start dialysis in the next 6 months
- Does not have access to facilities to receive delivery of, store, and heat or prepare intervention food
- Has a food allergy, intolerance or preferred diet that POH cannot accommodate with meal delivery (e.g. vegan diet). POH can accommodate many but not all diet restrictions.
- Does not live in Contra Costa County or plans to move out of the county in the next 6 months
- Another household member is already enrolled in the NU-DSMP study
Where it is running
- Contra Costa Health Services — Martinez, California, United States
Full record on ClinicalTrials.gov
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