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Intervention- High Dose for Type 2 Diabetes

N/A

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up survey completed at baseline, 3 months and 6 months

Awards & highlights

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ survey completed at baseline, 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~survey completed at baseline, 3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and survey completed at baseline, 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in HbA1c between baseline and 6 months

Secondary outcome measures

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.

+1 more

Trial Design

3Treatment groups

Active Control

Group I: Intervention- High DoseActive Control1 Intervention

Participation will last approximately 6 months. Participants enrolled in the high-dose intervention arm will receive a weekly produce delivery directly to their home in addition to the completion of 3 questionnaires and collection of the HbA1c at the end of study.

Group II: Intervention-Low DoseActive Control1 Intervention

Participation will last approximately 6 months. Participants enrolled in the low-dose intervention arm will receive a weekly produce delivery directly to their home in addition to the completion of 3 questionnaires and collection of the HbA1c at the end of study. The amount of produce provided in this arm will be lower per month per household size than the high dose arm.

Group III: Usual CareActive Control1 Intervention

Participation will last approximately 6 months. Participants enrolled in the Usual Care arm will complete 3 questionnaires and collection of the HbA1c at the end of study.

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Who is running the clinical trial?

Kaiser PermanenteLead Sponsor

538 Previous Clinical Trials

24,113,338 Total Patients Enrolled

Claudia L Nau, PhDPrincipal InvestigatorKaiser Permanente

1 Previous Clinical Trials

1,100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over 35 years of age eligible to participate in this clinical research?

"This study is only available to participants aged 18-70. Fortunately, separate clinical trials exist for those below or above the specified age range - 46 and 681 respectively."

Answered by AI

Is this study currently recruiting participants?

"At this time, the details on clinicaltrials.gov indicate that no further patients are being sought for this trial which was initially posted November 11th 2021 and most recently updated June 2nd 2022. Nonetheless, there remain 793 other active studies recruiting volunteers presently."

Answered by AI

Who has the opportunity to participate in this research project?

"To be eligible for this diabetes mellitus, type 2 study, one must fall between 18 and 70 years of age. The recruitment team is seeking to enrol approximately 450 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Food As Medicine Study

2021. "Food As Medicine Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05407376.