Food As Medicine Study

NCT05407376 | Completed

• 1 other identifier: 12876
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c between baseline and 6 months

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

  Baseline and 6 months after baseline assessment

Secondary Outcomes (4)

• Analyze the difference in difference of patient-reported food security between the intervention and control group.

  Survey completed at Baseline, 3 months and 6 months

• Analyze the difference in difference of patient-reported food-related self management between the intervention and control group.

  Survey completed at Baseline, 3 months and 6 months

• Analyze the difference in difference of patient-reported diet quality between the intervention and control group.

  Survey completed at Baseline, 3 months and 6 months

• Analyze the difference in difference of patient-reported nutritional security between the intervention and control group.

  Survey completed at Baseline, 3 months and 6 months

Study Arms (3)

Intervention- High Dose

ACTIVE COMPARATOR

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.

Other: Produce prescription (weekly produce delivery)

Intervention-Low Dose

ACTIVE COMPARATOR

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.

Other: Produce prescription (weekly produce delivery)

Usual Care

NO 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.

Interventions

Produce prescription (weekly produce delivery) OTHER

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

Intervention- High Dose; Intervention-Low Dose

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente Southern California

Pasadena, California, 91101, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Claudia L Nau, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: June 7, 2022
• Study Start: November 11, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)