Trial Outcomes & Findings for Pilot Trial of the Nutrition-Supported Diabetes Education Program (NCT NCT05067452)
NCT ID: NCT05067452
Last Updated: 2025-07-29
Results Overview
Change HbA1c levels (%) from baseline to twelve weeks by study arms
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Baseline and twelve weeks
Results posted on
2025-07-29
Participant Flow
Participant milestones
| Measure |
Standard of Care and Diabetes Self-management Education
Control participants will receive standard of care as offered by clinical partners to all type 2 diabetes mellitus (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.
|
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 (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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
21
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
| Measure |
Standard of Care and Diabetes Self-management Education
Control participants will receive standard of care as offered by clinical partners to all type 2 diabetes mellitus (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.
|
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 (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.
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
Baseline Characteristics
Error in laboratory result; one baseline value implausibly high (30.5). The value was removed (intervention group).
Baseline characteristics by cohort
| Measure |
Standard of Care and Diabetes Self-management Education
n=15 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=21 Participants
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.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 10.6 • n=15 Participants
|
56.0 years
STANDARD_DEVIATION 12.6 • n=21 Participants
|
54.1 years
STANDARD_DEVIATION 11.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=15 Participants
|
15 Participants
n=21 Participants
|
28 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=15 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White, Caucasian
|
0 Participants
n=15 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black, African American
|
4 Participants
n=15 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic, Latino
|
11 Participants
n=15 Participants
|
11 Participants
n=21 Participants
|
22 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian, Pacific Islander
|
0 Participants
n=15 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian, Native American
|
0 Participants
n=15 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other race/ethnicity
|
0 Participants
n=15 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=36 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · More than one race/ethnicity
|
0 Participants
n=15 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=36 Participants
|
|
Education
Less than high school
|
8 Participants
n=15 Participants
|
6 Participants
n=21 Participants
|
14 Participants
n=36 Participants
|
|
Education
High school/GED
|
5 Participants
n=15 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=36 Participants
|
|
Education
More than high school
|
2 Participants
n=15 Participants
|
11 Participants
n=21 Participants
|
13 Participants
n=36 Participants
|
|
Annual household income
Less than $10,000
|
6 Participants
n=15 Participants
|
6 Participants
n=21 Participants
|
12 Participants
n=36 Participants
|
|
Annual household income
$10,000 to $20,000
|
4 Participants
n=15 Participants
|
12 Participants
n=21 Participants
|
16 Participants
n=36 Participants
|
|
Annual household income
$20,000 to $30,000
|
4 Participants
n=15 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=36 Participants
|
|
Annual household income
$30,000 to $40,000
|
0 Participants
n=15 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=36 Participants
|
|
Annual household income
Over $40,000
|
0 Participants
n=15 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=36 Participants
|
|
Annual household income
Refused to answer
|
1 Participants
n=15 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=36 Participants
|
|
Has child dependents
|
8 Participants
n=15 Participants
|
8 Participants
n=21 Participants
|
16 Participants
n=36 Participants
|
|
HbA1c (%)
|
8.69 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.70 • n=15 Participants • Error in laboratory result; one baseline value implausibly high (30.5). The value was removed (intervention group).
|
8.24 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.68 • n=20 Participants • Error in laboratory result; one baseline value implausibly high (30.5). The value was removed (intervention group).
|
8.43 Percentage of glycated hemoglobin
STANDARD_DEVIATION 1.68 • n=35 Participants • Error in laboratory result; one baseline value implausibly high (30.5). The value was removed (intervention group).
|
|
HbA1c < 9%
|
9 Participants
n=15 Participants • Measure Analysis Population Description: Error in laboratory result; one baseline value implausibly high (30.5). The value was removed (intervention group).
|
15 Participants
n=20 Participants • Measure Analysis Population Description: Error in laboratory result; one baseline value implausibly high (30.5). The value was removed (intervention group).
|
24 Participants
n=35 Participants • Measure Analysis Population Description: Error in laboratory result; one baseline value implausibly high (30.5). The value was removed (intervention group).
|
|
Food security score
|
3.20 units on a scale
STANDARD_DEVIATION 2.83 • n=15 Participants
|
3.00 units on a scale
STANDARD_DEVIATION 2.83 • n=21 Participants
|
3.08 units on a scale
STANDARD_DEVIATION 2.79 • n=36 Participants
|
|
Low or very low food security
|
8 Participants
n=15 Participants
|
11 Participants
n=21 Participants
|
19 Participants
n=36 Participants
|
|
Healthy days (last 30 days)
|
16.2 days
STANDARD_DEVIATION 13.3 • n=15 Participants
|
13.3 days
STANDARD_DEVIATION 13.3 • n=21 Participants
|
14.5 days
STANDARD_DEVIATION 13.2 • n=36 Participants
|
|
Fruit and vegetable consumption
|
2.53 Cup equivalents per day
STANDARD_DEVIATION 1.19 • n=15 Participants
|
2.60 Cup equivalents per day
STANDARD_DEVIATION 1.03 • n=21 Participants
|
2.57 Cup equivalents per day
STANDARD_DEVIATION 0.987 • n=36 Participants
|
|
Added sugar consumption
|
11.94 teaspoon equivalents per day
STANDARD_DEVIATION 2.45 • n=15 Participants
|
12.4 teaspoon equivalents per day
STANDARD_DEVIATION 2.52 • n=21 Participants
|
12.2 teaspoon equivalents per day
STANDARD_DEVIATION 2.46 • n=36 Participants
|
|
Depressive symptom severity score (PHQ-8)
|
5.13 units on a scale
STANDARD_DEVIATION 6.32 • n=15 Participants
|
8.05 units on a scale
STANDARD_DEVIATION 6.21 • n=21 Participants
|
6.83 units on a scale
STANDARD_DEVIATION 6.34 • n=36 Participants
|
|
Diabetes self-efficacy score
|
29.2 units on a scale
STANDARD_DEVIATION 4.71 • n=15 Participants
|
30.5 units on a scale
STANDARD_DEVIATION 4.35 • n=21 Participants
|
30.0 units on a scale
STANDARD_DEVIATION 4.49 • n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline and twelve weeksChange HbA1c levels (%) from baseline to twelve weeks by study arms
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=13 Participants
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.
|
|---|---|---|
|
Change in Hemoglobin A1c (HbA1c) From Baseline to Twelve Weeks by Study Arm
|
-0.023 Percentage of glycated hemoglobin
Standard Deviation 1.63
|
0.131 Percentage of glycated hemoglobin
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Baseline and twelve weeksThe 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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=15 Participants
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.
|
|---|---|---|
|
Change in Food Security Severity From Baseline to Twelve Weeks by Study Arm
|
-1.31 score on a scale
Standard Deviation 3.17
|
0.067 score on a scale
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline and twelve weeksGlucose 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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=13 Participants
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.
|
|---|---|---|
|
Change in the Percentage of Participants With Glucose Control From Baseline to Twelve Weeks by Study Arm
|
7.70 Percentage of participants
|
-7.70 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and twelve weeksLow 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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=15 Participants
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.
|
|---|---|---|
|
Change in the Percentage of Participants With Low and Very Low Food Security From Baseline to Twelve Weeks by Study Arm
|
-15.4 Percentage of participants
|
20 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and twelve weeksHealth-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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=15 Participants
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.
|
|---|---|---|
|
Change in Health-related Quality of Life (Healthy Days) From Baseline to Twelve Weeks by Study Arm
|
-1.38 days
Standard Deviation 9.39
|
0.800 days
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Baseline and twelve weeksDietary 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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=15 Participants
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.
|
|---|---|---|
|
Change in Consumption of Fruits and Vegetables From Baseline to Twelve Weeks by Study Arm
|
0.294 cup equivalents
Standard Deviation 0.962
|
0.317 cup equivalents
Standard Deviation 0.973
|
SECONDARY outcome
Timeframe: Baseline and twelve weeksDietary 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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=15 Participants
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.
|
|---|---|---|
|
Change in Consumption of Added Sugars From Baseline to Twelve Weeks by Study Arm
|
-0.405 teaspoon equivalents
Standard Deviation 0.871
|
-0.944 teaspoon equivalents
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Baseline and twelve weeksThe 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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=15 Participants
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.
|
|---|---|---|
|
Change in Depressive Symptoms From Baseline to Twelve Weeks by Study Arm
|
0.154 score on a scale
Standard Deviation 2.70
|
-0.867 score on a scale
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Baseline and twelve weeksThe 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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=13 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=15 Participants
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.
|
|---|---|---|
|
Change in Diabetes Self-efficacy From Baseline to Twelve Weeks by Study Arm
|
2.69 score on a scale
Standard Deviation 3.84
|
0.067 score on a scale
Standard Deviation 4.76
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Twelve weeks and twenty-four weeksTo 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Twelve weeks and twenty-four weeksTo 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Twelve weeks and twenty-four weeksHealth-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.
Outcome measures
| Measure |
Standard of Care and Diabetes Self-management Education
n=15 Participants
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.
|
Diabetes-tailored Food Support Plus Diabetes Self-management Education
n=16 Participants
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.
|
|---|---|---|
|
Change in Health-related Quality of Life (Healthy Days) From Twelve Weeks to Twenty-four Weeks by Study Arm
|
1.31 days
Standard Deviation 7.17
|
-1.36 days
Standard Deviation 7.59
|
Adverse Events
Standard of Care and Diabetes Self-management Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diabetes-tailored Food Support Plus Diabetes Self-management Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Kartika Palar
University of California San Francisco
Phone: 415-502-8492
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place