Fruit and Vegetable Prescription in the Community Health Center Setting

NCT05144750 | Completed

• 1 other identifier: 2000030975
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Poverty

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

Secondary Outcomes (2)

• Fruit and Vegetable Consumption

  Month 1(baseline) and 8 (completion)

• Self Reported Improved Health

  Month 1(baseline) and 8 (completion)

Study Arms (1)

Fruit and Vegetable Prescription Program Cohort

EXPERIMENTAL

All participants received the program intervention.

Behavioral: Fruit and Vegetable Prescription

Interventions

Fruit and Vegetable Prescription BEHAVIORAL

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.

Also known as: Fruit and Vegetable Incentive

Fruit and Vegetable Prescription Program Cohort

Eligibility Criteria

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

You may qualify if:

• Type 2 Diabetes
• Low Income
• Patient of OCH

You may not qualify if:

• Under 18
• Does not speak Spanish or English

Sponsors & Collaborators

• Wholesome Wave: lead
• One Community Health: collaborator
• Yale-Griffin Prevention Research Center: collaborator

Study Sites (1)

One Community Health

Sacramento, California, 95825, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Fruit

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Kathleen Duffany

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: December 3, 2021
• Study Start: December 6, 2021
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)