ACTIVE_NOT_RECRUITING

Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults Study

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Conditions

Diabetes Mellitus, Type 2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study

Quick Facts

Study Start:2023-10-01
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06061861

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged ≥18 years old at enrollment
  2. * Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance
  3. * Diagnosis of Type II diabetes mellitus (not including Type I diabetes mellitus or gestational diabetes mellitus)
  4. * At least 2 outpatient glycosylated hemoglobin measures ≥7.5% in the prior 18 months
  5. * Current access to the internet via computer or mobile device
  6. * No interpreter needed
  1. * 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)
  2. * Known pregnancy at time of identification

Contacts and Locations

Principal Investigator

Claudia L Nau, PhD
PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Richard Grant, MD, MPH
PRINCIPAL_INVESTIGATOR
Kaiser Permanente

Study Locations (Sites)

Kaiser Permanente Southern California Department of Research & Evaluation
Pasadena, California, 91101
United States
Kaiser Permanente Northern California Division of Research
Pleasanton, California, 94588
United States

Collaborators and Investigators

Sponsor: Kaiser Permanente

  • Claudia L Nau, PhD, PRINCIPAL_INVESTIGATOR, Kaiser Permanente
  • Richard Grant, MD, MPH, PRINCIPAL_INVESTIGATOR, Kaiser Permanente

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-01
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-10-01
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 2