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Behavioural Intervention

Nutritional Interventions for Type 2 Diabetes (KP ENRICH Trial)

Phase 3
Recruiting
Led By Claudia L Nau, PhD
Research Sponsored by Kaiser Permanente
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults aged ≥18 years old at enrollment
Active membership in Kaiser Permanente with Medi-Cal insurance and no additional private or commercial insurance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-, 6-, and 12-months after enrollment
Awards & highlights

KP ENRICH Trial Summary

This trial will compare providing money for healthy food delivery to see if it reduces diabetes symptoms.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves nutritional interventions rather than medications, typical drug side effects are not expected. However, changes in diet may cause digestive adjustments or allergic reactions to new foods.

KP ENRICH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am a Kaiser Permanente member with only Medi-Cal insurance.
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I have been diagnosed with Type II diabetes.

KP ENRICH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-, 6-, and 12-months after enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-, 6-, and 12-months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
6-month change in glycosylated hemoglobin level
Secondary outcome measures
12-month change in glycosylated hemoglobin level
All-cause hospitalizations or emergency department visits
Change in self-reported diabetes-related quality of life
+5 more

KP ENRICH Trial Design

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.

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Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
541 Previous Clinical Trials
23,906,016 Total Patients Enrolled
Claudia L Nau, PhDPrincipal InvestigatorKaiser Permanente
1 Previous Clinical Trials
450 Total Patients Enrolled
Richard Grant, MD, MPHPrincipal InvestigatorKaiser Permanente
1 Previous Clinical Trials
817 Total Patients Enrolled
~660 spots leftby Jun 2025
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