Im(Proving) the CSA Model

July 24, 2017 updated by: Community Health Center of Franklin County

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Full study protocol is available upon request from Rochelle Bellin

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Greenfield, Massachusetts, United States, 01301
        • Recruiting
        • Community Health Center of Franklin County
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rochelle Bellin
        • Sub-Investigator:
          • Seth A Berkowitz, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HEI2010 Score
Time Frame: 19 months
The HEI 2010 score is an indicator of dietary quality.
19 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Related Quality of Life
Time Frame: 19 months
We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life
19 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Estimate the return on investment of CSA membership
Time Frame: 19 months
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
Time Frame: 19 months
Body Mass Index. This is an exploratory outcome and the study is not necessarily powered to detect changes
19 months
Blood Pressure
Time Frame: 19 months
Systolic and Diastolic Blood Pressure. This is an exploratory outcome and the study is not necessarily powered to detect changes
19 months
Hemoglobin A1c
Time Frame: 19 months
Hemoglobin A1c. This is an exploratory outcome and the study is not necessarily powered to detect changes
19 months
Lipids
Time Frame: 19 months
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
Time Frame: 19 months
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
Time Frame: 19 months
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
Time Frame: 19 months
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
Time Frame: 19 months
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
Time Frame: 19 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Community Health Center of Franklin County

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital
Just Roots

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edward Sayer, Community Health Center of Franklin County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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