CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Food support +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05067452
NCT05067452N/ACompleted

Pilot Study of the Nutrition-Supported Diabetes Education Program (NU-DSMP) Among Low-Income Adults With Type 2 Diabetes

University of California, San Francisco·interventional·Posted Oct 5, 2021·Updated Jul 29, 2025

In Brief

A clinical study evaluating Food support and Case-management for Diabetes Mellitus, Type 2. Completed, enrolled 36 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedOct 5, 2021
Enrollment StartNov 8, 2021
Primary CompletionMay 18, 2023
Study CompletionAug 16, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.7 years ago

Interventions

Food supportother

Diabetes-tailored food support. Project Open Hand (POH) will provide intervention participants twelve weeks of supplemental food support. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian. All food support will be home delivered.

Case-managementother

Project Open Hand client services staff will conduct three case management sessions with the participant. The first session will initiate food services and ensure orientation to the intervention and set up delivery; the second session will support the participant with any issues related to the intervention (logistical or nutrition-related, with referral to the POH registered dietitian as needed); the third session will provide transition from the intervention, connect the participant with local food resources, and ensure a "warm hand-off" to nutrition