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NCT05407376 · ClinicalTrials.gov registry record · NA
Food As Medicine Study
A NA study, sponsored by Kaiser Permanente.
- Completed
- Registry status
- NA
- Development phase
- 460
- Enrollment target
NCT05407376 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 460 participants.
The verdict
NCT05407376, a NA study, has completed, sponsored by Kaiser Permanente.
- COMPLETED
- Registry status
- NA
- Development phase
- 460 participants
- Enrollment target
Study Summary
The investigators are conducting a pre-randomized controlled trial to assess the effect of a 6 month Produce Prescription intervention for patients enrolled in Medicaid who experience consistently uncontrolled Hemoglobin A1c (HbA1c). The study is conducted at Kaiser Permanente Southern California, a large and diverse integrated health care system that serves 4.7 million members. Eligible participants are members aged 18 or older, currently enrolled in Medicaid who were diagnosed with diabetes for at least 24 months and had at least two Hba1c measurements of 7.5% or higher in the past 12 months. Patients in the intervention arm may enroll in tele nutrition counseling. The study team will recruit a total of 450. Participants, will be pre-randomized into one of three arms, 1) high dose intervention arm, a 2) low dose intervention and 3) a usual care group to achieve 150 participants enrolled in each arm. Produce is delivered weekly for participants of both intervention arms. Participants randomized to the high dose arm will receive a greater amount per month of produce versus the low dose amount (for a family of 3-4, $180 per month versus $135 respectively). Foods are provided along with recipes. The amount of food delivered is adjusted for each additional family member for up to 5 family members. The primary outcome is change in hemoglobin A1c pre-intervention and 6 months after enrollment. Secondary outcomes include, food insecurity status, dietary intake and other patient reported outcomes related to barriers to healthy eating including family conflict and cooking habits.
Interventions
- OTHER Produce prescription (weekly produce delivery)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 460 participants |
| Start Date | 2021-11-11 |
| Est. Completion | 2023-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05407376
The ClinicalTrials.gov registry entry for NCT05407376 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 460 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kaiser Permanente, which has 294 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Produce prescription (weekly produce delivery) is the first listed.
NCT05407376 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05407376 about?
NCT05407376 is a clinical study titled "Food As Medicine Study". The investigators are conducting a pre-randomized controlled trial to assess the effect of a 6 month Produce Prescription intervention for patients enrolled in Medicaid who experience consistently uncontrolled Hemoglobin A1c (HbA1c). The study is conducted at Kaiser Permanente Southern California, a...
What is the current status of trial NCT05407376?
This trial is currently completed. It is a NA study. The enrollment target is 460 participants. The study started on 2021-11-11. Estimated completion is 2023-04-30.
What interventions are being tested in trial NCT05407376?
The interventions under investigation include: Produce prescription (weekly produce delivery) (OTHER).
Who is sponsoring clinical trial NCT05407376?
This trial is sponsored by Kaiser Permanente, which has 294 total clinical trials registered on ClinicalTrials.gov.
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