NCT03231592

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

May 10, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

May 9, 2017

Last Update Submit

July 24, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • HEI2010 Score

    The HEI 2010 score is an indicator of dietary quality.

    19 months

Secondary Outcomes (1)

  • Health Related Quality of Life

    19 months

Other Outcomes (10)

  • Estimate the return on investment of CSA membership

    19 months

  • BMI

    19 months

  • Blood Pressure

    19 months

  • +7 more other outcomes

Study Arms (2)

CSA Group

EXPERIMENTAL

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

Enhanced Usual Care Group

ACTIVE COMPARATOR

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

Other: Enhanced Usual Care Group

Interventions

Already included in the arm descriptions.

CSA Group

Already included in the arm descriptions.

Enhanced Usual Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Health Center of Franklin County

Greenfield, Massachusetts, 01301, United States

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

OverweightObesityMalnutrition

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Edward Sayer

    Community Health Center of Franklin County

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2017

First Posted

July 27, 2017

Study Start

May 10, 2017

Primary Completion

December 20, 2018

Study Completion

December 20, 2018

Last Updated

July 27, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations