Clinical trial NCT05407376: Food As Medicine Study
Official title: Produce Prescriptions At Kaiser Permanente Southern California - an Innovative 'food As Medicine' Clinical Trial to Improve Food Insecurity and Health Among Medicaid Patients with Consistently Uncontrolled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in HbA1c between baseline and 6 months
timeFrame: Baseline and 6 months after baseline assessment
Secondary outcomes:
measure: Analyze the difference in difference of patient-reported food security between the intervention and control group.
timeFrame: Survey completed at Baseline, 3 months and 6 months
measure: Analyze the difference in difference of patient-reported food-related self management between the intervention and control group.
timeFrame: Survey completed at Baseline, 3 months and 6 months
measure: Analyze the difference in difference of patient-reported diet quality between the intervention and control group.
timeFrame: Survey completed at Baseline, 3 months and 6 months
measure: Analyze the difference in difference of patient-reported nutritional security between the intervention and control group.
timeFrame: Survey completed at Baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Claudia L Nau, PhD
role: PRINCIPAL_INVESTIGATOR
References: