Food As Medicine Study

NCT ID: NCT05407376

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2023-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention- High Dose

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 Type: ACTIVE_COMPARATOR

Produce prescription (weekly produce delivery)

Intervention Type: OTHER

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

Intervention-Low Dose

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 Type: ACTIVE_COMPARATOR

Produce prescription (weekly produce delivery)

Intervention Type: OTHER

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

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Produce prescription (weekly produce delivery)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age 18 years of age or older
• Diagnosed with Type 2 Diabetes for at least 24 months
• Diagnosed with Type 2 Diabetes and have at least two HbA1cs of 7.5% or higher in 12 months prior to recruitment
• Have MediCaid insurance at the time of their last hba1c test
• Will be able to provide informed consent
• Will be able to consent to research activities, including receiving a weekly produce box
• Will be able to receive and prepare delivered foods

Exclusion Criteria

• Pregnant women
• Living in a board and care where your meals are provided for you
• Unable to provide informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia L Nau, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente Southern California

Pasadena, California, United States

Countries

United States

Other Identifiers

12876

Identifier Type: -

Identifier Source: org_study_id