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Pilot Trial of the Nutrition-Supported Diabetes Education Program

NCT05067452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-07-29

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Food support

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.

OTHER

Case-management

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

Sponsors & Collaborators

  • Project Open Hand

    collaborator OTHER

  • Contra Costa Health Services

    collaborator OTHER_GOV

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Kartika Palar, PhD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-08
Primary Completion
2023-05-18
Completion
2023-08-16

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05067452 on ClinicalTrials.gov