NU-DSMP: Pilot Trial of the Nutrition-Supported Diabetes Education Program

Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05067452
Collaborator
Project Open Hand (Other), Contra Costa Health Services (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
72
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Food support
  • Other: Case-management
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
Double (Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Pilot Study of the Nutrition-Supported Diabetes Education Program (NU-DSMP) Among Low-Income Adults With Type 2 Diabetes
Anticipated Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

ArmIntervention/Treatment
No Intervention: Standard of care including diabetes self-management education

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.

Experimental: Diabetes-tailored food support plus diabetes self-management education

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
Diabetes-tailored food support. Project Open Hand 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

Outcome Measures

Primary Outcome Measures

  1. Change in Hemoglobin A1c (HbA1c) from baseline to twelve weeks by study arm [Baseline and twelve weeks]

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

  2. Change in food security severity from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

Secondary Outcome Measures

  1. Change in the proportion of participants with glucose control from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

  2. Change in the proportion of participants with low and very low food security from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

  3. Change in health-related quality of life (healthy days) from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

  4. Change in consumption of fruits and vegetables from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

  5. Change in consumption of added sugars from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

  6. Change in depressive symptoms from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

  7. Change in diabetes self-efficacy from baseline to twelve weeks by study arm [Baseline and twelve weeks]

    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.

Other Outcome Measures

  1. Change in HbA1c values from twelve weeks to twenty-four weeks by study arm [Twelve weeks and twenty-four weeks]

    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.

  2. Change in the proportion of participants with glycemic control from twelve weeks to twenty-four by study arm [Twelve weeks and twenty-four weeks]

    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.

  3. 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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Contra Costa Health ServicesMartinezCaliforniaUnited States94553

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Kartika Palar, PhD, University of California, San Francisco

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05067452
Other Study ID Numbers:
  • R21DK123632
  • R21DK123632
First Posted:
Oct 5, 2021
Last Update Posted:
Oct 5, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2021