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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Food support
Case-management
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring food security, nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Contra Costa Health ServicesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of care including diabetes self-management education

Diabetes-tailored food support plus diabetes self-management education

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c (HbA1c) from baseline to twelve weeks by study arm
Change HbA1c levels (%) from baseline to twelve weeks by study arms
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
September 21, 2021
Last Updated
October 14, 2022
Sponsor
University of California, San Francisco
Collaborators
Project Open Hand, Contra Costa Health Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05067452
Brief Title
Pilot Trial of the Nutrition-Supported Diabetes Education Program
Acronym
NU-DSMP
Official Title
Pilot Study of the Nutrition-Supported Diabetes Education Program (NU-DSMP) Among Low-Income Adults With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Project Open Hand, Contra Costa Health Services, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
food security, nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
InvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of care including diabetes self-management education
Arm Type
No Intervention
Arm Description
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.
Arm Title
Diabetes-tailored food support plus diabetes self-management education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Food support
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Case-management
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c (HbA1c) from baseline to twelve weeks by study arm
Description
Change HbA1c levels (%) from baseline to twelve weeks by study arms
Time Frame
Baseline and twelve weeks
Title
Change in food security severity from baseline to twelve weeks by study arm
Description
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
Secondary Outcome Measure Information:
Title
Change in the proportion of participants with glucose control from baseline to twelve weeks by study arm
Description
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.
Time Frame
Baseline and twelve weeks
Title
Change in the proportion of participants with low and very low food security from baseline to twelve weeks by study arm
Description
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.
Time Frame
Baseline and twelve weeks
Title
Change in health-related quality of life (healthy days) from baseline to twelve weeks by study arm
Description
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.
Time Frame
Baseline and twelve weeks
Title
Change in consumption of fruits and vegetables from baseline to twelve weeks by study arm
Description
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
Title
Change in consumption of added sugars from baseline to twelve weeks by study arm
Description
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
Title
Change in depressive symptoms from baseline to twelve weeks by study arm
Description
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
Title
Change in diabetes self-efficacy from baseline to twelve weeks by study arm
Description
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
Other Pre-specified Outcome Measures:
Title
Change in HbA1c values from twelve weeks to twenty-four weeks by study arm
Description
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.
Time Frame
Twelve weeks and twenty-four weeks
Title
Change in the proportion of participants with glycemic control from twelve weeks to twenty-four by study arm
Description
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.
Time Frame
Twelve weeks and twenty-four weeks
Title
Change in health-related quality of life (healthy days) from twelve weeks to twenty-four weeks by study arm
Description
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.
Time Frame
Twelve weeks and twenty-four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kartika Palar, PhD
Phone
628-206-7159
Email
kartika.palar@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lizet Campos, BS
Email
lizet.campos@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kartika Palar, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Contra Costa Health Services
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Will Sheldon, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Trial of the Nutrition-Supported Diabetes Education Program

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