Evaluating financial support for healthy food in adults with type 2 diabetes
Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study
This study is testing if giving financial help for healthy food delivery can improve blood sugar levels in adults with type 2 diabetes who are struggling to manage their condition.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kaiser Permanente Academic / other |
| Locations | 2 sites (Pasadena, California and 1 other locations) |
| Trial ID | NCT06061861 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial aims to assess the impact of providing monetary support for healthy food delivery on glycosylated hemoglobin (HbA1c) levels in adults with type 2 diabetes who have suboptimal glycemic control. Participants will be divided into two groups: one receiving financial support for healthy food through Instacart, and the other receiving only free food delivery. The study will evaluate changes in HbA1c levels, medical resource utilization, and patient-reported outcomes over a 6-month period. The goal is to determine if financial assistance for healthy eating can improve diabetes management and overall health.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with Medi-Cal insurance, diagnosed with type 2 diabetes, and experiencing suboptimal glycemic control.
Not a fit: Patients with advanced kidney disease or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve glycemic control and health outcomes for patients with type 2 diabetes.
How similar studies have performed: Other studies have shown promising results with nutritional interventions in diabetes management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged ≥18 years old at enrollment * Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance * Diagnosis of Type II diabetes mellitus (not including Type I diabetes mellitus or gestational diabetes mellitus) * At least 2 outpatient glycosylated hemoglobin measures ≥7.5% in the prior 18 months * Current access to the internet via computer or mobile device * No interpreter needed Exclusion Criteria: * 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) * Known pregnancy at time of identification
Where this trial is running
Pasadena, California and 1 other locations
- Kaiser Permanente Southern California Department of Research & Evaluation — Pasadena, California, United States (Recruiting)
- Kaiser Permanente Northern California Division of Research — Pleasanton, California, United States (Recruiting)
Study contacts
- Principal investigator: Claudia L Nau, PhD — Kaiser Permanente
- Study coordinator: Thida C Tan, MPH
- Email: thida.x.tan@kp.org
- Phone: 510-891-5982
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.