KP ENRICH: Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study
Study Details
Study Description
Brief Summary
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:
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To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces glycosylated hemoglobin levels within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.
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To evaluate whether providing monthly financial support for home-delivered healthy food vs. only free food delivery through the Instacart platform reduces medical resource utilization within 6 months among Medi-Cal-insured Kaiser Permanente adult members with diabetes mellitus and suboptimal glycemic control.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Eligible Kaiser Permanente adult members will be randomized to one of two groups:
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Intervention arm, in which subjects will receive 6 months of monetary support (with up to 4 free home deliveries and no service fees) through the Instacart platform to select and receive healthy foods (e.g., vegetables and fruit).
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Control arm, in which subjects will receive 6 months of free home deliveries and no service fees for up to 4 deliveries each month through the Instacart platform.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Financial Support and Free Delivery The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform. |
Other: Financial support for healthy foods and free home delivery
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.
|
| Experimental: Free Delivery The control group will receive only free home delivery through the Instacart platform. |
Other: Free home delivery
Participants will have home delivery and service fees waived for 4 orders per month through the Instacart platform for a duration of 6 months.
|
Outcome Measures
Primary Outcome Measures
- 6-month change in glycosylated hemoglobin level [6 months after enrollment]
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.
Secondary Outcome Measures
- 12-month change in glycosylated hemoglobin level [12 months after enrollment]
Glycosylated hemoglobin will be ascertained using routine laboratory tests in the electronic health record at 12 months after enrollment.
- Percentage of participants with glycosylated hemoglobin <7.5% [6- and 12-months after enrollment]
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.
- All-cause hospitalizations or emergency department visits [3-, 6-, and 12-months after enrollment]
Occurrence of hospitalization or emergency department visit for any reason within 12 months after enrollment.
- Change in self-reported level of food security [6- and 12-months after enrollment]
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).
- Change in self-reported level of nutrition security [6- and 12-months after enrollment]
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.
- Change in self-reported dietary habits [6- and 12-months after enrollment]
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.
- Change in self-reported diabetes-related quality of life [6- and 12-months after enrollment]
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.
- Change in self-reported readiness to change [6- and 12-months after enrollment]
Participants will be asked about their readiness to change their dietary habits to manage their diabetes on a 5-point Likert scale.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged ≥18 years old at enrollment
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Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance
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Diagnosis of Type II diabetes mellitus (not including Type I diabetes mellitus or gestational diabetes mellitus)
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At least 2 outpatient glycosylated hemoglobin measures ≥7.5% in the prior 18 months
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Current access to the internet via computer or mobile device
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No interpreter needed
Exclusion Criteria:
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Advanced or end-stage kidney disease (estimated glomerular filtration rate ≤15 ml/min/1.73m^2 or receiving outpatient dialysis or having a prior kidney transplant)
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Known pregnancy at time of identification
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Southern California Department of Research & Evaluation | Pasadena | California | United States | 91101 |
Sponsors and Collaborators
- Kaiser Permanente
Investigators
- Principal Investigator: Claudia L Nau, PhD, Kaiser Permanente
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2042958