Pilot Trial of the Nutrition-Supported Diabetes Education Program

NCT05067452 | Completed Results DMC

• 1 other identifier: R21DK123632
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

food security; nutrition

Outcome Measures

Primary Outcomes (2)

• Change in Hemoglobin A1c (HbA1c) From Baseline to Twelve Weeks by Study Arm

  Change HbA1c levels (%) from baseline to twelve weeks by study arms

  Baseline and twelve weeks

• Change in Food Security Severity From Baseline to Twelve Weeks by Study Arm

  The US household food security survey module (adult version) from the US Department of Agriculture (USDA) will be used to assess the change in the food security scores from baseline to twelve weeks. The score ranges from 0 to 10. Higher score indicates higher severity of food insecurity.

  Baseline and twelve weeks

Secondary Outcomes (7)

• Change in the Percentage of Participants With Glucose Control From Baseline to Twelve Weeks by Study Arm

  Baseline and twelve weeks

• Change in the Percentage of Participants With Low and Very Low Food Security From Baseline to Twelve Weeks by Study Arm

  Baseline and twelve weeks

• Change in Health-related Quality of Life (Healthy Days) From Baseline to Twelve Weeks by Study Arm

  Baseline and twelve weeks

• Change in Consumption of Fruits and Vegetables From Baseline to Twelve Weeks by Study Arm

  Baseline and twelve weeks

• Change in Consumption of Added Sugars From Baseline to Twelve Weeks by Study Arm

  Baseline and twelve weeks

Other Outcomes (3)

• Change in HbA1c Values From Twelve Weeks to Twenty-four Weeks by Study Arm

  Twelve weeks and twenty-four weeks

• Change in the Proportion of Participants With Glycemic Control From Twelve Weeks to Twenty-four by Study Arm

  Twelve weeks and twenty-four weeks

• Change in Health-related Quality of Life (Healthy Days) From Twelve Weeks to Twenty-four Weeks by Study Arm

  Twelve weeks and twenty-four weeks

Study Arms (2)

Standard of care including diabetes self-management education

NO INTERVENTION

Control participants will receive standard of care as offered by clinical partners to all T2DM patients, including referral to nutritional counseling, T2DM support groups, and participation in local diabetes self-management programs. Control participants are also often provided referral information for locally available food support services in the region that provide diabetes-appropriate foods. Control participants will participate in the Diabetes Self-Management Program, an evidence-based program that takes place over 6 weeks that meets the standard of care for diabetes education. At the end of follow up, the control arm will receive three months diabetes-tailored food support consisting of diabetes-tailored grocery boxes and nutrition case-management.

Diabetes-tailored food support plus diabetes self-management education

EXPERIMENTAL

The intervention has two components: 1) diabetes-tailored food support that consists of weekly, home-delivered medically tailored meals, and monthly home-delivered healthy groceries, from baseline to 24 weeks, and 2) three case-management sessions with client services staff from the partnering nutrition agency over the 12 weeks of intervention. The intervention will be delivered in addition to a base condition consisting of remote participation in the Diabetes Self-Management Program, an evidence-based diabetes education program that takes place over 6 weeks also received by the control group as part of the standard of care.

Other: Food support; Other: Case-management

Interventions

Food support OTHER

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.

Diabetes-tailored food support plus diabetes self-management education

Case-management OTHER

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

Diabetes-tailored food support plus diabetes self-management education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Project Open Hand: collaborator
• Contra Costa Health Services: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Contra Costa Health Services

Martinez, California, 94553, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Case Management

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Dr. Kartika Palar
• Organization: University of California San Francisco

kartika.palar@ucsf.edu

415-502-8492

Study Officials

• Kartika Palar, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The analyst(s) and investigator(s) conducting and reviewing the analyses of the data will be masked to whether participants were in the intervention or control arm.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants (n=72) will be randomized to the intervention (n=36) or control (n=36) arms. The intervention consists of providing diabetes-tailored food support and individualized case management over 12 weeks to patients with type 2 diabetes.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 5, 2021
• Study Start: November 8, 2021
• Primary Completion: May 18, 2023
• Study Completion: August 16, 2023
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)