Diabetes Mellitus, Type 2 Clinical Trial
— NU-DSMPOfficial title:
Pilot Study of the Nutrition-Supported Diabetes Education Program (NU-DSMP) Among Low-Income Adults With Type 2 Diabetes
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | August 15, 2023 |
Est. primary completion date | May 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Contra Costa Health Services | Martinez | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Contra Costa Health Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Project Open Hand |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in HbA1c values from twelve weeks to twenty-four weeks by study arm | To evaluate durability of changes, if any, in HbA1c after the intervention ended, the change in HbA1c levels (%) from 12 weeks to 24 weeks by study arm will be reported. | Twelve weeks and twenty-four weeks | |
Other | Change in the proportion of participants with glycemic control from twelve weeks to twenty-four by study arm | To evaluate durability of changes, if any, in glycemic control after the intervention ended, the change in the percent of participants with HbA1c levels less than 9% from 12 weeks to 24 weeks by study arm will be reported. | Twelve weeks and twenty-four weeks | |
Other | Change in health-related quality of life (healthy days) from twelve weeks to twenty-four weeks by study arm | Health-related quality of life will be measured using the Summary Index of Unhealthy Days collected via the 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. To evaluate the durability of changes, if any, in health-related quality of life, the change in healthy days from 12 weeks to 24 weeks by study arm will be reported. | Twelve weeks and twenty-four weeks | |
Primary | 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 | |
Primary | 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 | Change in the proportion 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 proportion of participants with glucose control will be reported. | Baseline and twelve weeks | |
Secondary | Change in the proportion 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 proportion of participants with low or very low food security, from baseline to twelve weeks by intervention arms will be reported. | Baseline and twelve weeks | |
Secondary | 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 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. | Baseline and twelve weeks | |
Secondary | 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. | Baseline and twelve weeks | |
Secondary | 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. | Baseline and twelve weeks | |
Secondary | 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. | Baseline and twelve weeks | |
Secondary | 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. | Baseline and twelve weeks |
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