Im(Proving) the CSA Model

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).

Study Overview

• Status: Unknown
• Conditions: Diet Modification; Overweight and Obesity; Nutrition Poor
• Intervention / Treatment: Other: CSA Group; Other: Enhanced Usual Care Group

Detailed Description

Full study protocol is available upon request from Rochelle Bellin

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Greenfield, Massachusetts, United States, 01301
      • Recruiting
      • Community Health Center of Franklin County
      • Contact: Edward Sayer; Phone Number: 108 413-325-8500; Email: edward.sayer@chcfc.org
      • Contact: Maegan Petrie; Phone Number: 128 (413) 325-8500; Email: Maegan.Petrie@chcfc.org
      • Sub-Investigator: Rochelle Bellin
      • Sub-Investigator: Seth A Berkowitz, MD

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSA Group; 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.	Other: CSA Group; Already included in the arm descriptions.
Active Comparator: Enhanced Usual Care Group; This group will receive a handout about healthy eating, in addition to routine care in their primary care practice.	Other: Enhanced Usual Care Group; Already included in the arm descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HEI2010 Score	The HEI 2010 score is an indicator of dietary quality.	19 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Related Quality of Life	We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life	19 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimate the return on investment of CSA membership	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.	19 months
BMI	Body Mass Index. This is an exploratory outcome and the study is not necessarily powered to detect changes	19 months
Blood Pressure	Systolic and Diastolic Blood Pressure. This is an exploratory outcome and the study is not necessarily powered to detect changes	19 months
Hemoglobin A1c	Hemoglobin A1c. This is an exploratory outcome and the study is not necessarily powered to detect changes	19 months
Lipids	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	19 months
Food Insecurity	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	19 months
Anxiety Symptoms	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	19 months
Depressive Symptoms	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	19 months
Cost Related Medication Underuse	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	19 months
Food-Medication Trade-Offs	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	19 months

Collaborators and Investigators

• Sponsor: Community Health Center of Franklin County
• Collaborators: Massachusetts General Hospital; Just Roots
• Investigators: Principal Investigator: Edward Sayer, Community Health Center of Franklin County

Publications and helpful links

General Publications

• 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.

Helpful Links

• 24-hour dietary recall tool to be used at each Research Visit to assess participants previous 24 hours of consumption

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2017
• Primary Completion (Anticipated): December 20, 2018
• Study Completion (Anticipated): December 20, 2018

Study Registration Dates

• First Submitted: May 9, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Overweight; Malnutrition
• Other Study ID Numbers: FMPP2016

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