Clinical trial NCT05067452: Pilot Trial of the Nutrition-Supported Diabetes Education Program
Official title: Pilot Study of the Nutrition-Supported Diabetes Education Program (NU-DSMP) Among Low-Income Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: food security
nutrition
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Project Open Hand
name: Contra Costa Health Services
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-10-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Together with Contra Costa Health Services, a safety-net county health system, and Project Open Hand, a non-profit organization with extensive experience providing nutrition services to low-income, chronically ill individuals in the San Francisco Bay Area, the investigators will conduct the Nutrition-Supported Diabetes Education Program (NU-DSMP) Pilot Study. The goal for this pragmatic, pilot randomized trial is to test the feasibility, acceptability and preliminary impact of providing 12 weeks of diabetes-healthy food support (i.e. medically tailored meals and groceries) supported by individualized case-management to low-income individuals with type 2 diabetes mellitus (T2DM) participating in the evidence-based Diabetes Self- Management Program (DSMP), compared to DSMP participation alone.

The study will randomize 72 individuals 1:1 to intervention and control arms, following them at 0, 12 and 24 weeks with surveys and medical record review (with an interim brief 6 week assessment with the survey only), to understand the impact on diabetes health. Data from this pilot study will inform the planning of a full-size randomized trial to test the efficacy of the NU-DSMP model, with a long-term goal to inform policy debates about the value of implementing medically tailored food interventions as part of healthcare.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Hemoglobin A1c (HbA1c) from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
measure: Change in food security severity from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
Secondary outcomes:
measure: Change in the proportion of participants with glucose control from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
measure: Change in the proportion of participants with low and very low food security from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
measure: Change in health-related quality of life (healthy days) from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
measure: Change in consumption of fruits and vegetables from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
measure: Change in consumption of added sugars from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
measure: Change in depressive symptoms from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
measure: Change in diabetes self-efficacy from baseline to twelve weeks by study arm
timeFrame: Baseline and twelve weeks
Other outcomes:
measure: Change in HbA1c values from twelve weeks to twenty-four weeks by study arm
timeFrame: Twelve weeks and twenty-four weeks
measure: Change in the proportion of participants with glycemic control from twelve weeks to twenty-four by study arm
timeFrame: Twelve weeks and twenty-four weeks
measure: Change in health-related quality of life (healthy days) from twelve weeks to twenty-four weeks by study arm
timeFrame: Twelve weeks and twenty-four weeks
Locations:
city: Martinez
country: United States
facility: Contra Costa Health Services
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kartika Palar, PhD
role: PRINCIPAL_INVESTIGATOR
References: