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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
36
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.
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
Contra Costa Health Services
Martinez, California, United States
Change in Hemoglobin A1c (HbA1c) From Baseline to Twelve Weeks by Study Arm
Change HbA1c levels (%) from baseline to twelve weeks by study arms
Time frame: 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.
Time frame: Baseline and twelve weeks
Change in the Percentage of Participants With Glucose Control From Baseline to Twelve Weeks by Study Arm
Glucose control will be defined as HbA1c lower than 9%. The change from baseline to twelve weeks, in the percentage of participants with glucose control will be reported.
Time frame: 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
Low and very low food security will be defined as 3 or more items answered affirmatively in the USDA's US household food security survey module. Change in the percentage of participants with low or very low food security, from baseline to twelve weeks by intervention arms will be reported.
Time frame: Baseline and twelve weeks
Change in Health-related Quality of Life (Healthy Days) From Baseline to Twelve Weeks by Study Arm
Health-related quality of life will be measured using the Summary Index of Unhealthy Days collected via the Centers for Disease Control (CDC) Healthy Days scale. This scale asks the number of days in the past 30 days the person felt physically or mentally unwell. The summary index then estimates the number of recent days when a person's physical and mental health was good (or better) and is calculated by subtracting the number of unhealthy days from 30 days. The change in healthy days from baseline to twelve weeks by study arm will be reported.
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Time frame: Baseline and twelve weeks
Change in Consumption of Fruits and Vegetables From Baseline to Twelve Weeks by Study Arm
Dietary information using the Dietary Screener Questionnaire (DSQ) will be collected. The DSQ obtains information on the frequency of consumption of fruits and vegetables. These responses are then converted to cup equivalents per day using a scoring algorithm based on the NHANES 24-hour recall. Fruit and vegetable consumption from baseline to twelve weeks by study arm will be reported.
Time frame: Baseline and twelve weeks
Change in Consumption of Added Sugars From Baseline to Twelve Weeks by Study Arm
Dietary information using the Dietary Screener Questionnaire (DSQ) will be collected. The DSQ obtains information on the frequency of consumption of added sugars. These responses are then converted to teaspoon equivalents per day using a scoring algorithm based on the NHANES 24-hour recall. Added sugars consumption (teaspoon equivalents per day) from baseline to twelve weeks by study arm will be reported.
Time frame: Baseline and twelve weeks
Change in Depressive Symptoms From Baseline to Twelve Weeks by Study Arm
The 8-item Patient Health Questionnaire (PHQ-8) will be used to evaluate depressive symptoms. The PHQ-8 score ranges from 0 to 24, with higher scores indicating higher levels of depression. The change in PHQ-8 scores from baseline to twelve weeks by study arm will be reported.
Time frame: Baseline and twelve weeks
Change in Diabetes Self-efficacy From Baseline to Twelve Weeks by Study Arm
The 8-item Diabetes Self-Efficacy scale will be used to assess confidence in one's ability to manage numerous self-care behaviors. The scores ranges from 8 to 40, with higher scores indicating more confidence in self-managing their diabetes. The changes in the scores from baseline to twelve weeks by study arm will be reported.
Time frame: Baseline and twelve weeks