Clinical trial NCT05144750: Fruit and Vegetable Prescription in the Community Health Center Setting
Official title: Fruit and Vegetable Prescription in the Community Health Center Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Poverty
Lead sponsor: Wholesome Wave
Sponsor class: OTHER
Collaborators: name: One Community Health
name: Yale-Griffin Prevention Research Center
First posted: 2021-12-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The proposed study examines the implementation and efficacy of a fruit and vegetable incentive program in a population of adults with diabetes at a community health center (CHC) in California. Additionally, we seek to understand the impact of this program on the participants with particular attention to their experience and point of view. To better understand the program and its impact, a mixed methods approach will be used.

Detailed description: The proposed research will utilize a mixed methods approach with both qualitative and quantitative methods to assess the process and impact of a fruit and vegetable incentive program administered in a community clinic that serves a population that is low-income in Sacramento, California.

Sacramento County has a population of 1.5 million people and 500,000 people living in the city of Sacramento proper. The poverty rate of the county over all is 12.6% and the city is 16.6%. The most recent estimate of county level food insecurity is 12%, which is consistent with the national average; however, the estimated rate during the COVID 19 pandemic is 16.5%. Sacramento also serves as an ideal region for intervention because there is a strong community partner with the CHC, One Community Health (OCH) and there are regionally accessible Walmart stores at which the fruit and vegetable incentives (i.e., Walmart gift cards) can be used. Participants in the study will receive up to $400 in fruit and vegetable vouchers over 8 months, $50 in voucher given per household each month (paused if no voucher redemption within prior 2 months).

The intervention adds a $50 monthly fruit and vegetable voucher, and text reminder and educational text messages (recipes/tips) to the Standard of Care for patients.

Standard Care for Patients at OCH: Patients/participants will be able to regularly meet with their healthcare team which includes but is not limited to a primary care physician, nursing staff, dietitians and other providers as needed. All care is based on evidence-based best clinical practices and the patient's voluntary involvement with their providers.

Fruit and Vegetable Incentive: During the 8-month intervention period, registered program participants can receive $50 monthly through the reloadable Walmart gift card, which can only be used to purchase fresh fruits and vegetables. The total incentive will be $400 for the eight-month program. Each month, program participants will be able to receive their monthly $50 incentive, providing their balance at the time of the reload does not exceed $100, due to two months of inactivity. Monthly reload plan will be made based on available balance during the first week of each month, with the reload planned for the 15th of each month.

Text Communication: Participants will share a text-enabled phone number with Wholesome Wave for Wholesome Wave to send text reminders to shop and utilize incentives, likely 2 times per month. Wholesome Wave will also share text messages that are consistent with the messages that the OCH dietitians are offering in their standard care, including recipes and tips.

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* Low Income
* Patient of OCH

Exclusion Criteria:

* Under 18
* Does not speak Spanish or English

Primary outcomes:
measure: Change in Body Mass Index from Baseline to End of Program
timeFrame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
measure: Change in HbA1c from Baseline to End of Program
timeFrame: All clinical measurements were collected at month 1 (baseline) to 8 (completion)
measure: Glycemic Control
timeFrame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
measure: Change in Blood Lipids HDL Ratio from Baseline to end of Program
timeFrame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
measure: Change in Blood Lipids LDL Ratio from Baseline to end of Program
timeFrame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
measure: Change in Blood Pressure from Baseline to end of Program
timeFrame: All clinical measurements were collected at month 1 (baseline) and 8 (completion)
measure: Change in Food Security
timeFrame: Month 1(baseline) and 8 (completion)
Secondary outcomes:
measure: Fruit and Vegetable Consumption
timeFrame: Month 1(baseline) and 8 (completion)
measure: Self Reported Improved Health
timeFrame: Month 1(baseline) and 8 (completion)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: One Community Health
state: California
Study officials:
affiliation: Yale University
name: Kathleen Duffany
role: PRINCIPAL_INVESTIGATOR
References: