Fruit and Vegetable Prescription in the Community Health Center Setting

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus; Poverty
• Intervention / Treatment: Behavioral: Fruit and Vegetable Prescription

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95825
      • One Community Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Type 2 Diabetes
• Low Income
• Patient of OCH

Exclusion Criteria:

• Under 18
• Does not speak Spanish or English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Fruit and Vegetable Prescription Program Cohort; All participants received the program intervention.

Behavioral: Fruit and Vegetable Prescription; 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 will be able to regularly meet with their healthcare team. 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. Text Communication: Wholesome Wave will share text reminders to shop and utilize incentives. 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.; Other Names: Fruit and Vegetable Incentive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Food Security	Food security will be measured using the USDA Household Food Security Measure. The score will be calculated following the USDA HFSM guide and change in food security will be reported as end of program score - beginning of program score.	Month 1(baseline) and 8 (completion)
Change in Body Mass Index from Baseline to End of Program	Body mass index was calculated from height in meters and weight in kilograms: Height and Weight will be collected at months 1, 4 and 8 and at any additional clinic visits when appropriate. Weight and height will be combined to report BMI in kg/m^2	All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in HbA1c from Baseline to End of Program	Glycated hemoglobin A1c (HbA1c) was used to measure the average plasma glucose concentration. HbA1c will be measured using a finger-prick test. HbA1c will be reported as HbA1c% and Blood Glucose (mmol/L). Change in HbA1C will be calculated as end of program HbA1c% - baseline HbA1c%.	All clinical measurements were collected at month 1 (baseline) to 8 (completion)
Glycemic Control	Glycemic control: Glycated hemoglobin A1c (HbA1c) will be used to measure the average plasma glucose concentration. HbA1c will be measured using a finger-prick test. HbA1c will be reported as HbA1c% and Blood Glucose (mmol/L). Glycemic control will be determined inline with American Diabetes Association guidelines. According to the ADA HbA1C values lower than 5.7% represents a normal range, between 5.7% and 6.5% is prediabetes and greater than 6.5% is diabetes.	All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in Blood Lipids HDL Ratio from Baseline to end of Program	Blood lipids: Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by clinical staff at OCH and run through their typical lab procedures that are part of standard of care, the values will be shared with researchers for months 1 and 8. HDL:Tchol ratio will also be computed. Change in HDL ration will be calculated as End of Program HDL ratio- beginning of the program HDL ratio.	All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in Blood Lipids LDL Ratio from Baseline to end of Program	Blood lipids: Values of total cholesterol (Tchol), triglycerides (TG), and high-density lipoprotein (HDL) will be obtained by clinical staff at OCH and run through their typical lab procedures that are part of standard of care, the values will be shared with researchers for months 1 and 8. Serum low-density lipoprotein (LDL) will be calculated using the following formula LDL = Tchol - (TG/5 + HDL). Change in LDL ratio will be calculated as End of Program LDL ratio- beginning of the program LDL ratio.	All clinical measurements were collected at month 1 (baseline) and 8 (completion)
Change in Blood Pressure from Baseline to end of Program	Blood pressure: Blood pressure will be collected at by clinical staff at OCH at months 1 and 8 and at other clinical appointments as is medically appropriate, using an automatic blood pressure measurement device. Blood pressure will be measures as Systolic mm Hg/ diastolic mm Hg. Following the standards delineated by the CDC, systolic: less than 120 mm Hg diastolic: less than 80 mm Hg; systolic: 120-139 mm Hg diastolic: 80-89 mm Hg; and systolic: 140 mm Hg or higher diastolic: 90 mm Hg or higher. Change in blood pressure will be calculated change in (8 months systolic-1 month systolic) systolic over the change in diastolic (8 months diastolic-1 month diastolic).	All clinical measurements were collected at month 1 (baseline) and 8 (completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fruit and Vegetable Consumption	Fruit and vegetable consumption data will be measured using a short form fruit and vegetable food frequency questionnaire. The food frequency questionnaire will be scored and change in consumption will be calculated as end of program score - start of program score.	Month 1(baseline) and 8 (completion)
Self Reported Improved Health	Self-reported improved health will be measured using the RAND single-item measure. Change in score will be calculated as change in mean.	Month 1(baseline) and 8 (completion)

Collaborators and Investigators

• Sponsor: Wholesome Wave
• Collaborators: Yale-Griffin Prevention Research Center; One Community Health
• Investigators: Principal Investigator: Kathleen Duffany, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2000030975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No