Intervention- High Dose for Diabetes Mellitus, Type 2

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Kaiser Permanente Southern California, Pasadena, CA
Diabetes Mellitus, Type 2
Produce prescription (weekly produce delivery) - Other
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether a Produce Prescription intervention, where patients receive a weekly delivery of produce and recipes, can help control their diabetes. The intervention in this trial is high dose, which is used to treat diabetes mellitus, type 2. There will be no patients in this trial who will receive a placebo.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Survey completed at Baseline, 3 months and 6 months

Month 6
Change in HbA1c between baseline and 6 months
Month 6
Analyze the difference in difference of patient-reported diet quality between the intervention and control group.
Analyze the difference in difference of patient-reported food security between the intervention and control group.
Analyze the difference in difference of patient-reported food-related self management between the intervention and control group.
Analyze the difference in difference of patient-reported nutritional security between the intervention and control group.

Trial Safety

Safety Progress

1 of 3

Other trials for Diabetes Mellitus, Type 2

Trial Design

3 Treatment Groups

Intervention- High Dose
1 of 3
Intervention-Low Dose
1 of 3
Usual Care
1 of 3
Active Control

450 Total Participants · 3 Treatment Groups

Primary Treatment: Intervention- High Dose · No Placebo Group · N/A

Intervention- High Dose
Other
ActiveComparator Group · 1 Intervention: Produce prescription (weekly produce delivery) · Intervention Types: Other
Intervention-Low Dose
Other
ActiveComparator Group · 1 Intervention: Produce prescription (weekly produce delivery) · Intervention Types: Other
Usual CareNoIntervention Group · 1 Intervention: Usual Care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: survey completed at baseline, 3 months and 6 months
Closest Location: Kaiser Permanente Southern California · Pasadena, CA
Photo of california 1Photo of california 2Photo of california 3
2009First Recorded Clinical Trial
3 TrialsResearching Diabetes Mellitus, Type 2
11 CompletedClinical Trials

Who is running the clinical trial?

Kaiser PermanenteLead Sponsor
497 Previous Clinical Trials
22,185,767 Total Patients Enrolled
14 Trials studying Diabetes Mellitus, Type 2
276,001 Patients Enrolled for Diabetes Mellitus, Type 2
Claudia L Nau, PhDPrincipal InvestigatorKaiser Permanente

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to consent to research activities, including receiving a weekly produce box.
You must be at least 18 years old to donate blood.
You have Type 2 Diabetes for at least 24 months.
You have Type 2 Diabetes and have had two HbA1c values of 7.
You have MediCaid insurance at the time of their last hba1c test.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.