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Im(Proving) the CSA Model

Primary Purpose

Overweight and Obesity, Nutrition Poor, Diet Modification

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CSA Group
Enhanced Usual Care Group
Sponsored by
Community Health Center of Franklin County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight and Obesity

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or older
  • BMI > 25 kg/m2 in the past 1 year
  • Willing to commit to random assignment to either receive CSA membership or enhanced care control
  • Stable health, with no severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization
  • Be willing to keep a food diary for one week
  • Be willing to attend and complete 5 examinations
  • Be able to understand and communicate effectively in English
  • Ability to store and prepare food

Exclusion Criteria:

  • Must not be pregnant or planning pregnancy in the next year
  • Currently enrolled in another study of dietary quality
  • Life threatening food allergy to component of CSA boxes
  • Currently enrolled in other CSA, or planning to enroll in CSA if assigned to enhanced usual care control group

Sites / Locations

  • Community Health Center of Franklin CountyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CSA Group

Enhanced Usual Care Group

Arm Description

This group will receive CSA Shares (a selection of fresh fruits and vegetables from a local farm) each week for 24 weeks over the summer of 2017 and 2018. The CSA does not operate over the winter.

This group will receive a handout about healthy eating, in addition to routine care in their primary care practice.

Outcomes

Primary Outcome Measures

HEI2010 Score
The HEI 2010 score is an indicator of dietary quality.

Secondary Outcome Measures

Health Related Quality of Life
We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life

Full Information

First Posted
May 9, 2017
Last Updated
July 24, 2017
Sponsor
Community Health Center of Franklin County
Collaborators
Just Roots, Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03231592
Brief Title
Im(Proving) the CSA Model
Official Title
Im(Proving) the CSA Model
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
December 20, 2018 (Anticipated)
Study Completion Date
December 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Community Health Center of Franklin County
Collaborators
Just Roots, Massachusetts General Hospital

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
In 1986, The Pioneer Valley in Western Massachusetts was home to one of the first two community supported agriculture (CSA) businesses in the USA. In 2014, there were 6,200 CSAs across the states, and today, in the Pioneer Valley alone, there are sixty CSAs. As with many parts of the United States, there are too many CSAs competing for the same pool of middle and upper-class customers. In his research at the University of Massachusetts in 2014, Mark Paul stated CSA farms are trapped in a lose-lose conundrum in which the farmers are not making enough money for a living wage, while simultaneously CSA shares are too expensive for many community members. The central challenge facing the CSA model moving forward is to provide fair compensation to farmers and farm workers, while making shares available at prices that can attract more members of the community. "(Im)Proving the CSA Model" proposes to increase consumption of and access to local products AND to develop new market opportunities for farms by opening the CSA membership base nationwide to low-income consumers and more price conscious middle class consumers. The investigators will do this by researching and documenting the health benefits of belonging to a CSA program. The investigators expect the resulting data to justify insurance-provided cash "wellness" benefits for CSA participation, much like those currently provided for gym membership. A wellness benefit will provide the financial incentive necessary to open CSA programs to lower- and middle-income consumers. The two-year research study intends to demonstrate that enrolling community health center patients in a Community Supported Agriculture (CSA) program is feasible and leads to dietary improvements that would be expected to offer clinical benefits in larger scale studies over longer timeframes. To maximize the knowledge gained from participation in this study, the investigators will measure several self-reported, laboratory, and clinical outcomes, but the primary purpose of this study is to provide pilot data for the model. To test this the investigators will implement a randomized controlled clinical trial design, with individual-level randomization of 120 participants, assigned in 1:1 ratio to receipt of a CSA membership (goal: 60 participants) or enhanced usual care (goal: 60 participants).
Detailed Description
Full study protocol is available upon request from Rochelle Bellin

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Nutrition Poor, Diet Modification

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CSA Group
Arm Type
Experimental
Arm Description
This group will receive CSA Shares (a selection of fresh fruits and vegetables from a local farm) each week for 24 weeks over the summer of 2017 and 2018. The CSA does not operate over the winter.
Arm Title
Enhanced Usual Care Group
Arm Type
Active Comparator
Arm Description
This group will receive a handout about healthy eating, in addition to routine care in their primary care practice.
Intervention Type
Other
Intervention Name(s)
CSA Group
Intervention Description
Already included in the arm descriptions.
Intervention Type
Other
Intervention Name(s)
Enhanced Usual Care Group
Intervention Description
Already included in the arm descriptions.
Primary Outcome Measure Information:
Title
HEI2010 Score
Description
The HEI 2010 score is an indicator of dietary quality.
Time Frame
19 months
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Description
We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life
Time Frame
19 months
Other Pre-specified Outcome Measures:
Title
Estimate the return on investment of CSA membership
Description
To estimate the return on investment of CSA membership. We will use effects on dietary quality and quality of life obtained from Outcome 1 and employ an existing microsimulation model of health expenditures to determine the change in health expenditures attributable to program participation divided by the costs of the program to calculate the 'return on investment'. The focus of our analysis will be identifying health effects that are relevant to accountable care organizations and insurers with the goal of informing adoption of the CSA model.
Time Frame
19 months
Title
BMI
Description
Body Mass Index. This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Blood Pressure
Description
Systolic and Diastolic Blood Pressure. This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Hemoglobin A1c
Description
Hemoglobin A1c. This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Lipids
Description
Non-fasting lipid panels (including total cholesterol, HDL, triglycerides, and LDL if calculable). This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Food Insecurity
Description
USDA Food Security Survey module, 10 adult referenced items, modified to have a 1 month look back period, using standard scoring. This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Anxiety Symptoms
Description
Measured using the PROMIS Emotional Distress Anxiety 4 item short-form.This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Depressive Symptoms
Description
Measured using the PROMIS Emotional Distress Depression 4 item short-form. This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Cost Related Medication Underuse
Description
Measured using the 4 cost-related medication underuse items from MEPS/NHISThis is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months
Title
Food-Medication Trade-Offs
Description
4 questions about trade-offs between affording food, medications, and meeting other basic needs. This is an exploratory outcome and the study is not necessarily powered to detect changes
Time Frame
19 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older BMI > 25 kg/m2 in the past 1 year Willing to commit to random assignment to either receive CSA membership or enhanced care control Stable health, with no severe medical comorbidities that might interfere with their ability to participate in the intervention, such as severe psychiatric illness or imminent hospitalization Be willing to keep a food diary for one week Be willing to attend and complete 5 examinations Be able to understand and communicate effectively in English Ability to store and prepare food Exclusion Criteria: Must not be pregnant or planning pregnancy in the next year Currently enrolled in another study of dietary quality Life threatening food allergy to component of CSA boxes Currently enrolled in other CSA, or planning to enroll in CSA if assigned to enhanced usual care control group
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rochelle Bellin
Phone
(413) 325-8969
Email
rochelle@justroots.org
First Name & Middle Initial & Last Name or Official Title & Degree
Edward Sayer
Phone
(413) 325-8500
Ext
108
Email
edward.sayer@chcfc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Sayer
Organizational Affiliation
Community Health Center of Franklin County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Health Center of Franklin County
City
Greenfield
State/Province
Massachusetts
ZIP/Postal Code
01301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Sayer
Phone
413-325-8500
Ext
108
Email
edward.sayer@chcfc.org
First Name & Middle Initial & Last Name & Degree
Maegan Petrie
Phone
(413) 325-8500
Ext
128
Email
Maegan.Petrie@chcfc.org
First Name & Middle Initial & Last Name & Degree
Rochelle Bellin
First Name & Middle Initial & Last Name & Degree
Seth A Berkowitz, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31522922
Citation
Berkowitz SA, O'Neill J, Sayer E, Shahid NN, Petrie M, Schouboe S, Saraceno M, Bellin R. Health Center-Based Community-Supported Agriculture: An RCT. Am J Prev Med. 2019 Dec;57(6 Suppl 1):S55-S64. doi: 10.1016/j.amepre.2019.07.015. Epub 2019 Sep 12.
Results Reference
derived
Links:
URL
https://asa24.nci.nih.gov/
Description
24-hour dietary recall tool to be used at each Research Visit to assess participants previous 24 hours of consumption

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Im(Proving) the CSA Model

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