Pilot Trial of the Nutrition-Supported Diabetes Education Program

Pilot Study of the Nutrition-Supported Diabetes Education Program (NU-DSMP) Among Low-Income Adults With Type 2 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05067452

Acronym

NU-DSMP

Enrollment

Registered

2021-10-05

Start date

2021-11-08

Completion date

2023-08-16

Last updated

2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

food security, nutrition

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.

Interventions

OTHERFood support

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.

OTHERCase-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Measure	Time frame	Description
Change in the Percentage 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 the percentage 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	Baseline and twelve weeks	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.
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.
Change in the Percentage 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 percentage of participants with glucose control will be reported.
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.
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.
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

Measure	Time frame	Description
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Standard of Care and 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.	15
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 (same as control group). 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. 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; the third session will provide transition from the intervention and connect the participant with local food resources.	21
Total	36

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	4

Baseline characteristics

Characteristic	Standard of Care and Diabetes Self-management Education	Diabetes-tailored Food Support Plus Diabetes Self-management Education	Total
Added sugar consumption	11.94 teaspoon equivalents per day STANDARD_DEVIATION 2.45	12.4 teaspoon equivalents per day STANDARD_DEVIATION 2.52	12.2 teaspoon equivalents per day STANDARD_DEVIATION 2.46
Age, Continuous	51.5 years STANDARD_DEVIATION 10.6	56.0 years STANDARD_DEVIATION 12.6	54.1 years STANDARD_DEVIATION 11.7
Annual household income $10,000 to $20,000	4 Participants	12 Participants	16 Participants
Annual household income $20,000 to $30,000	4 Participants	0 Participants	4 Participants
Annual household income $30,000 to $40,000	0 Participants	1 Participants	1 Participants
Annual household income Less than $10,000	6 Participants	6 Participants	12 Participants
Annual household income Over $40,000	0 Participants	2 Participants	2 Participants
Annual household income Refused to answer	1 Participants	0 Participants	1 Participants
Depressive symptom severity score (PHQ-8)	5.13 units on a scale STANDARD_DEVIATION 6.32	8.05 units on a scale STANDARD_DEVIATION 6.21	6.83 units on a scale STANDARD_DEVIATION 6.34
Diabetes self-efficacy score	29.2 units on a scale STANDARD_DEVIATION 4.71	30.5 units on a scale STANDARD_DEVIATION 4.35	30.0 units on a scale STANDARD_DEVIATION 4.49
Education High school/GED	5 Participants	4 Participants	9 Participants
Education Less than high school	8 Participants	6 Participants	14 Participants
Education More than high school	2 Participants	11 Participants	13 Participants
Food security score	3.20 units on a scale STANDARD_DEVIATION 2.83	3.00 units on a scale STANDARD_DEVIATION 2.83	3.08 units on a scale STANDARD_DEVIATION 2.79
Fruit and vegetable consumption	2.53 Cup equivalents per day STANDARD_DEVIATION 1.19	2.60 Cup equivalents per day STANDARD_DEVIATION 1.03	2.57 Cup equivalents per day STANDARD_DEVIATION 0.987
Has child dependents	8 Participants	8 Participants	16 Participants
HbA1c (%)	8.69 Percentage of glycated hemoglobin STANDARD_DEVIATION 1.7	8.24 Percentage of glycated hemoglobin STANDARD_DEVIATION 1.68	8.43 Percentage of glycated hemoglobin STANDARD_DEVIATION 1.68
HbA1c < 9%	9 Participants	15 Participants	24 Participants
Healthy days (last 30 days)	16.2 days STANDARD_DEVIATION 13.3	13.3 days STANDARD_DEVIATION 13.3	14.5 days STANDARD_DEVIATION 13.2
Low or very low food security	8 Participants	11 Participants	19 Participants
Race/Ethnicity, Customized Race/Ethnicity American Indian, Native American	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race/Ethnicity Asian, Pacific Islander	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Race/Ethnicity Black, African American	4 Participants	4 Participants	8 Participants
Race/Ethnicity, Customized Race/Ethnicity Hispanic, Latino	11 Participants	11 Participants	22 Participants
Race/Ethnicity, Customized Race/Ethnicity More than one race/ethnicity	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Race/Ethnicity Other race/ethnicity	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Race/Ethnicity White, Caucasian	0 Participants	3 Participants	3 Participants
Sex: Female, Male Female	13 Participants	15 Participants	28 Participants
Sex: Female, Male Male	2 Participants	6 Participants	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 15	0 / 21
other Total, other adverse events	0 / 15	0 / 21
serious Total, serious adverse events	0 / 15	0 / 21

Outcome results

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.