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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: Completed NA study, sponsored by Kaiser Permanente.

NCT05407376 is a NA study that has completed, run by Kaiser Permanente. The registered enrollment target is 460 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Both intervention and control participants will have their HbA1c tested at baseline and 6 months after the baseline assessment.

Interventions

  • OTHER Produce prescription (weekly produce delivery)

Trial Details

FieldValue
Enrollment Target 460 participants
Start Date 2021-11-11
Est. Completion 2023-04-30
Phase NA
Kaiser Permanente

294 total trials

What the finished NCT05407376 record still lists

NCT05407376 is an interventional study that assigns participants to a tested intervention. The registered 460 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (67% lower).

The record links to 0 conditions, and to 1 intervention - of which Produce prescription (weekly produce delivery) is the first listed.

NCT05407376 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05407376's enrollment target sits among peer trials

460 222nd of 2000 higher than 1,777 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05407376, the US trial registry maintained by the National Library of Medicine. NCT05407376 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.