Nutritional Interventions for Type 2 Diabetes
(KP ENRICH Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Kaiser Permanente
Disqualifiers: Advanced kidney disease, Pregnancy, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?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:
1. 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.
2. 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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems to focus on dietary changes rather than medication adjustments.
What data supports the effectiveness of the treatment Financial support for healthy foods and free home delivery for Type 2 Diabetes?
Research shows that programs providing fresh produce and nutrition education can improve diet quality and health outcomes, such as better blood sugar control, in people with diabetes. These programs, like the Produce Rx program, have been successful in increasing fruit and vegetable consumption and improving attitudes towards healthy eating.
12345Is the Nutritional Intervention for Type 2 Diabetes safe for humans?
The studies on food prescription and delivery programs, like those for diabetes patients, show they are generally safe and well-received, with high participant satisfaction and improved food security. No specific safety concerns were reported in these studies.
26789How is the treatment of financial support for healthy foods and free home delivery unique for type 2 diabetes?
This treatment is unique because it combines financial support for healthy foods with free home delivery, specifically targeting food insecurity and promoting better nutrition among patients with type 2 diabetes. Unlike traditional treatments that focus on medication, this approach addresses social determinants of health by ensuring access to nutritious food, which can improve overall health and potentially reduce health disparities.
237910Eligibility Criteria
This trial is for adults over 18 with Type 2 diabetes, poor glycemic control (HbA1c ≥7.5%), and Medi-Cal insurance through Kaiser Permanente. Participants need internet access and can't have other private insurance, advanced kidney disease, be on dialysis or post-kidney transplant, or be pregnant.Inclusion Criteria
Current access to the internet via computer or mobile device
No interpreter needed
I am 18 years old or older.
+3 more
Exclusion Criteria
Known pregnancy at time of identification
My kidney function is very low, I'm on dialysis, or I've had a kidney transplant.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 6 months of monetary support for healthy food or free delivery through the Instacart platform
6 months
Monthly assessments
Follow-up
Participants are monitored for changes in glycosylated hemoglobin levels and other health outcomes
6 months
Assessments at 6 and 12 months
Long-term follow-up
Participants' medical resource utilization and other outcomes are evaluated
12 months
Assessments at 3, 6, and 12 months
Participant Groups
The study tests if financial support for healthy food delivery affects blood sugar control in high-risk diabetic patients better than just free delivery. It's a randomized trial comparing two groups: one gets money towards healthy foods plus delivery; the other only gets the delivery service.
2Treatment groups
Experimental Treatment
Group I: Free DeliveryExperimental Treatment1 Intervention
The control group will receive only free home delivery through the Instacart platform.
Group II: Financial Support and Free DeliveryExperimental Treatment1 Intervention
The intervention group will receive monthly financial support for healthy food items along with free home delivery through the Instacart platform.
Financial support for healthy foods and free home delivery is already approved in United States for the following indications:
🇺🇸 Approved in United States as Financial Support for Healthy Foods and Free Home Delivery for:
- Type 2 Diabetes Mellitus with Suboptimal Glycemic Control
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Kaiser Permanente Northern California Division of ResearchPleasanton, CA
Kaiser Permanente Southern California Department of Research & EvaluationPasadena, CA
Loading ...
Who Is Running the Clinical Trial?
Kaiser PermanenteLead Sponsor
References
Prompting a Fresh Start for Adults With Food Insecurity and Increased BMI: A Case Series of Four Patients in a Food Prescription Program. [2021]Estimates place low intake of fruits and vegetables, physical inactivity, and high BMI (overweight-obesity) as all in the top 12 causes of death. Food and dietary education are becoming a focus in how we approach disease prevention and management, and food prescription programs in particular are showing promise, especially in under-resourced, food-insecure communities. This paper describes a pilot food prescription program in a handful of uninsured patients enrolled in an interprofessional clinical and educational program of a medical school in South Florida. This case series of four patients struggling with food insecurity profiles the demographic and clinical characteristics of the participants and provides the results of standardized assessments of their dietary behaviors, physical activity levels, and attitudes toward food before and after the intervention. This four-month pilot food prescription program, Fresh Start Food Rx, involved a prospective case report of four patients seen on a mobile health center (MHC) for uninsured patients in South Miami, Florida. The MHC is part of an interprofessional health professions education, health care, and social service program of the Herbert Wertheim College of Medicine at Florida International University called the Neighborhood Health Education Learning Program (NeighborhoodHELP). A systematic review of South Miami MHC patient electronic medical records identified eligible participants for the program: patients with food insecurity and a BMI >30, with comorbid health conditions. Patients with greater BMI and more comorbidities were prioritized. Once enrolled, we provided biweekly packages of fresh fruits and vegetables along with monthly dietary education to the participants. Key measures included self-reported fruit and vegetable consumption, attitude toward healthy eating, and level of activity. Pre- and post-intervention focus groups assessed barriers the participants faced to eating healthy and pursuing physical activity, satisfaction with the program, feedback on strengths and weaknesses, and anticipated behavioral changes after completion of the program. Prior to the intervention, participants reported eating fruits on an average of 4.5 days out of the week. Post-survey answers increased to 5.0 days per week. Though the average amount of days per week that participants reported eating vegetables decreased slightly, the average number of vegetable servings that participants reported eating in a week increased. At termination of the program, most participants agreed that a diet rich in fruits and vegetables is good for you, that it is important to eat fruits and vegetables every day, and that a diet rich in fruits and vegetables can protect against cancer. This case study demonstrates that easier access to healthy foods, such as fresh produce delivery, and regular health education have the potential to promote healthier attitudes toward foods like fruits and vegetables. This change in attitude can then influence behavior, such as choosing to try new produce or increasing the amount and frequency of produce consumption. With the lessons learned from this small pilot program, the authors helped facilitate the expansion of a larger food prescription program in conjunction with a community partner hospital in the area. Findings from this experience might prove useful for others attempting to develop or expand a food prescription and health education program of their own.
"Prevention Produce": Integrating Medical Student Mentorship into a Fruit and Vegetable Prescription Program for At-Risk Patients. [2020]Fruit and vegetable prescription (FVRx) programs provide increased access to produce to food-insecure, at-risk populations, yet many lack the educational and social components to support long-term disease prevention.
Foods for Health: An Integrated Social Medical Approach to Food Insecurity Among Patients With Diabetes. [2022]Examine a clinic-based approach to improve food security and glycemic control among patients with diabetes.
A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. [2023]Food provision interventions (eg, produce/food prescriptions, food pharmacies, food voucher programs) that bridge clinic and community settings for improved nutritional health outcomes of at-risk patients have gained momentum. Little is known about the role of nutrition education and potential augmented impact on patient outcomes.
Development and Evaluation of the Delivery-Based HEALED Produce Rx Program for Uninsured Patients With Diabetes in Rural Eastern North Carolina. [2023]Produce prescription (PRx) programs have emerged as a preventive treatment to subsidize the cost of fruits and vegetables for people with lower income and have shown promise in improving diet quality and diabetes-related health outcomes (eg, glycated hemoglobin A1c). Researchers from the Department of Nutrition Science at East Carolina University worked with the Wayne Action Teams for Community Health (WATCH) Clinic, a safety-net clinic in rural Eastern North Carolina, and a local research farm to develop a PRx program for rural patients with type 2 diabetes and no health insurance. Preliminary patient surveys identified high levels of interest in a PRx program and a desire for recipes to accompany the produce. Formative evaluation results via telephone interviews with eligible patients identified transportation barriers to participation and the desire for complementary nutrition education and culinary resources. These results led to a delivery-based PRx program implemented from June through November 2021. Patients received weekly home delivery of an average of 4.7 pounds of fruits and vegetables and complementary nutrition and health education materials and culinary resources (cookbook, recipes). The level of patient satisfaction with the program was high; the reported level of consumption of produce, including unfamiliar produce, was high; educational resources were associated with increased knowledge and motivation to make healthful lifestyle changes, and glycemic control significantly improved. Ensuring that patients have a voice in the design and implementation of PRx programs is crucial to success. Ongoing use of rigorous formative and process evaluations can ensure appropriateness, use, and a positive effect of PRx programs, and they are needed to establish best practices for implementation.
Qualitative Study on Participant Perceptions of a Supermarket Fruit and Vegetable Incentive Program. [2023]Complete Eats Rx is a fruit and vegetable prescription program designed to incentivize fruit and vegetable consumption among Supplemental Nutrition Assistance Program (SNAP) participants via $10 incentives distributed either weekly or per encounter to purchase fruits and vegetables at a mid-price supermarket chain in Washington State.
Food Rx: a community-university partnership to prescribe healthy eating on the South Side of Chicago. [2018]Patients living with diabetes in underserved communities face significant challenges to healthy eating. To support them, we need interventions that integrate community resources into the healthcare setting. A "prescription" for healthy food may be a promising platform for such a community-linked intervention: it can promote behavior change, provide nutrition education, include financial incentives, and connect patients to local resources. We describe Food Rx, a food prescription collaboratively developed by a university research team, Walgreens, a local farmers market, and six health centers on the South Side of Chicago. We share preliminary lessons learned from implementation, highlighting how each stakeholder (university, community partners, and clinics) contributed to this multifaceted effort while meeting research standards, organizational priorities, and clinic workflow demands. Although implementation is in early stages, Food Rx shows promise as a model for integrating community and healthcare resources to support the health of underserved patients.
Strategies and Challenges: Qualitative Lessons Learned From Georgia Produce Prescription Programs. [2022]Produce prescription programs (PPPs) have grown in numbers in the past decade, empowering health care providers to promote health by issuing subsidies for produce to vulnerable patients. However, little research has been conducted on the facilitators that make it easier for PPPs to succeed or the barriers that programs face, which could provide guidance on how to improve future PPP design and implementation. The study sought to identify the facilitators and barriers affecting positive outcomes in Georgia PPPs called Fruit and Vegetable Prescription (FVRx) Programs. A process evaluation with a qualitative comparative case study approach was conducted. Fifteen FVRx providers, ranging from nutrition educators to farmers market managers, were interviewed in a focus group interview or on the phone between 2016 and 2017. Two nutrition education classes and an FVRx best practices meeting were observed, and program documents were collected. Interview transcripts, field notes from observations, and documents were then thematically analyzed. Four overall themes were determined regarding facilitators and barriers experienced by FVRx programs: (1) creating accessible programming may encourage FVRx participation, (2) provider dedication to the program is important, (3) participants' challenging life circumstances can make participation difficult, and (4) the sustainability of the program is a concern. The findings of this study suggest helpful strategies and challenges for providers to consider when developing and implementing PPPs in Georgia and beyond. Research on the long-term program impact is needed, and policy options for sustainable, scaling up of PPPs should be explored.
A Collaborative Pilot to Support Patients With Diabetes Through Tailored Food Box Home Delivery. [2023]We conducted a randomized, controlled prospective pilot study to determine feasibility and impact of food bank and health system collaboration to home-delivered food to adults with type 2 diabetes mellitus experiencing food insecurity. Treatment group received biweekly, ethnically tailored, home-delivered food for 24 weeks. Analysis included intervention feasibility and impact on healthcare utilization, HbA1c, and other health-related measures. Intervention was feasible and successful with high levels of participant satisfaction. At baseline, participants with highest HbA1c reported poorer health, lower medication adherence and self-care, and higher diabetes distress and medicine for food tradeoffs. At 24 weeks, treatment group reported improved food security and health status. There were no differences in HbA1c or healthcare utilization measures between the two groups. It is feasible for a community food bank and nearby hospital to successfully collaborate and provide supplemental food staples to food insecure adults with type 2 diabetes and improve food insecurity and health status. Public policy efforts should utilize and expand this strategy with the goal of improving health and reducing health disparities. Future work could include more comprehensive food support focused on those with poorest glycemic control, and expanded, coordinated interventions directed at other social determinants of health. Future programming and policies should be cocreated with community input to ensure greatest success.
"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. [2020]Medically-tailored meal programs that provide home-delivered medically-appropriate food are an emerging intervention when type 2 diabetes co-occurs with food insecurity (limited or uncertain access to nutritious food owing to cost). We sought to understand the experiences of medically-tailored meal program participants.