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Food As Medicine Study

NCT05407376 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2025-03-24

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

Produce prescription (weekly produce delivery)

Participants will receive weekly produce deliveries and recipes sent directly to their homes for 6 months.

Sponsors & Collaborators

  • Kaiser Permanente

    lead OTHER

Principal Investigators

  • Claudia L Nau, PhD · Kaiser Permanente

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05407376 on ClinicalTrials.gov