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Fruit and Vegetable Prescription in the Community Health Center Setting

Primary Purpose

Diabetes Mellitus, Diabetes Mellitus, Type 2, Poverty

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fruit and Vegetable Prescription
Sponsored by
Wholesome Wave
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Type 2 Diabetes
  • Low Income
  • Patient of OCH

Exclusion Criteria:

  • Under 18
  • Does not speak Spanish or English

Sites / Locations

  • One Community HealthRecruiting

Outcomes

Primary Outcome Measures

Change in Body Mass Index from Baseline to End of Program
Body mass index will be 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
Change in HbA1c from Baseline to End of Program
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). Change in HbA1C will be calculated as end of program HbA1c% - baseline HbA1c%.
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.
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.
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.
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).
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 3, 2021
Last Updated
December 9, 2021
Sponsor
Wholesome Wave
Collaborators
One Community Health, Yale-Griffin Prevention Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05144750
Brief Title
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
August 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wholesome Wave
Collaborators
One Community Health, Yale-Griffin Prevention Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetes Mellitus, Type 2, Poverty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Fruit and Vegetable Prescription
Other Intervention Name(s)
Fruit and Vegetable Incentive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Body Mass Index from Baseline to End of Program
Description
Body mass index will be 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
Time Frame
All clinical measurements will be collected at month 1 (baseline) and 8 (completion)
Title
Change in HbA1c from Baseline to End of Program
Description
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). Change in HbA1C will be calculated as end of program HbA1c% - baseline HbA1c%.
Time Frame
All clinical measurements will be collected at month 1 (baseline) to 8 (completion)
Title
Glycemic Control
Description
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.
Time Frame
All clinical measurements will be collected at month 1 (baseline) and 8 (completion)
Title
Change in Blood Lipids HDL Ratio from Baseline to end of Program
Description
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.
Time Frame
All clinical measurements will be collected at month 1 (baseline) and 8 (completion)
Title
Change in Blood Lipids LDL Ratio from Baseline to end of Program
Description
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.
Time Frame
All clinical measurements will be collected at month 1 (baseline) and 8 (completion)
Title
Change in Blood Pressure from Baseline to end of Program
Description
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).
Time Frame
All clinical measurements will be collected at month 1 (baseline) and 8 (completion)
Title
Change in Food Security
Description
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.
Time Frame
Month 1(baseline) and 8 (completion)
Secondary Outcome Measure Information:
Title
Fruit and Vegetable Consumption
Description
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.
Time Frame
Month 1(baseline) and 8 (completion)
Title
Self Reported Improved Health
Description
Self-reported improved health will be measured using the RAND single-item measure. Change in score will be calculated as change in mean.
Time Frame
Month 1(baseline) and 8 (completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 Diabetes Low Income Patient of OCH Exclusion Criteria: Under 18 Does not speak Spanish or English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John McAndrew
Phone
914-393-4226
Email
john@wholesomewave.org
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Feinstein
Phone
203-506-4867
Email
natalia@wholesomewave.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Duffany
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
One Community Health
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Luckett
Phone
916-443-3299
Email
aluckett@onecommunityhealth.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Fruit and Vegetable Prescription in the Community Health Center Setting

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