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The goal of this randomized controlled trial is to compare the effect of receiving 6 months of monetary support for healthy food through a food delivery platform on change in glycosylated hemoglobin (HbA1c) levels among adults with type 2 diabetes mellitus with glycemic control that is above target level.
The main study aims are to:
Eligible Kaiser Permanente adult members will be randomized to one of two groups:
Glycosylated hemoglobin level will be assessed at baseline and at 6 months after enrollment. Medical resource utilization will be evaluated at 3 months, 6 months, and 12 months after enrollment. Patient-reported outcomes (i.e., diabetes quality of life, nutrition security, dietary habits, social needs, and food security) will also be assessed at baseline, 6 months, and 12 months after enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial Support and Free Delivery | Experimental | The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform. |
|
| Free Delivery | Experimental | The control group will receive only free home delivery through the Instacart platform. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial support for healthy foods and free home delivery | Other | Participants will receive monetary support to spend on healthy food items (e.g., vegetables and fruit) through the Instacart platform for a duration of 6 months and have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-month change in glycosylated hemoglobin level | Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin testing 6 months after enrollment. | 6 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 12-month change in glycosylated hemoglobin level | Glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record at 12 months after enrollment. | 12 months after enrollment |
| Percentage of participants with glycosylated hemoglobin <7.5% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia L Nau, PhD | Kaiser Permanente | Principal Investigator |
| Richard Grant, MD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Southern California Department of Research & Evaluation | Pasadena | California | 91101 | United States | ||
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005378 | Financial Support |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
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| Free home delivery | Other | Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months. |
|
Baseline glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record prior to enrollment. Participants will complete glycosylated hemoglobin tests 6 months after enrollment. 12-month glycosylated hemoglobin level will be ascertained using routine laboratory tests in the electronic health record. |
| 6- and 12-months after enrollment |
| All-cause hospitalizations or emergency department visits | Occurrence of hospitalization or emergency department visit for any reason within 12 months after enrollment. | 3-, 6-, and 12-months after enrollment |
| Change in self-reported level of food security | Participants will answer 10 questions about their food security using the USDA adult food security module. Affirmative responses to questions will be assigned 1 point in the food security scale (out of 10). Participants will be classified as being food secure (0-2 points) or food insecure (3-10 points). | 6- and 12-months after enrollment |
| Change in self-reported level of nutrition security | Participants will be asked about their level of difficulty in accessing healthy food on a 5-point Likert scale. Participants will also be asked 13 questions on reasons for not eating healthy food, with each question scored from 0-2 (Never, Sometimes, Often true). Lower scores indicate higher nutrition security. | 6- and 12-months after enrollment |
| Change in self-reported dietary habits | Participants will be asked 8 questions to examine their consumption of fast food, fruits, vegetables, legumes, nuts, dairy, seafood, sweets, and sugar-sweetened beverages over the past month. | 6- and 12-months after enrollment |
| Change in self-reported diabetes-related quality of life | Participants will answer 13 questions about their diabetes-related quality of life, each on a 5-point Likert scale. Scores range from 13-65, with higher scores indicating lower diabetes-related quality of life. | 6- and 12-months after enrollment |
| Change in self-reported readiness to change | Participants will be asked about their readiness to change their dietary habits to manage their diabetes on a 5-point Likert scale. | 6- and 12-months after enrollment |
| Kaiser Permanente Northern California Division of Research |
| Pleasanton |
| California |
| 94588 |
| United States |
| D004700 | Endocrine System Diseases |