Status:
ACTIVE_NOT_RECRUITING
Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study
Lead Sponsor:
Kaiser Permanente
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
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 (...
Detailed Description
Eligible Kaiser Permanente adult members will be randomized to one of two groups: 1. Intervention arm, in which subjects will receive 6 months of monetary support (with up to 4 free home deliveries a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
1007 Patients enrolled
Trial Details
Trial ID
NCT06061861
Start Date
October 1 2023
End Date
June 1 2026
Last Update
January 8 2026
Active Locations (2)
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1
Kaiser Permanente Southern California Department of Research & Evaluation
Pasadena, California, United States, 91101
2
Kaiser Permanente Northern California Division of Research
Pleasanton, California, United States, 94588