Recruiting

Observational Study

Sponsor:

Community Health Center of Franklin County

Code:

NCT03231592

Conditions

Overweight and Obesity

Nutrition Poor

Diet Modification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CSA Group

Enhanced Usual Care Group

Study Details

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).

Conditions

Overweight and Obesity

Nutrition Poor

Diet Modification

Study ID

NCT03231592

Start date

May 10, 2017

Status verified date

Jul, 2017

Completion date

Dec 20, 2018

Anticipated

Primary completion date

Dec 20, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

CSA Group

Already included in the arm descriptions.

Enhanced Usual Care Group

Already included in the arm descriptions.

Primary outcome measure

  • HEI2010 Score [ Time Frame: 19 months ]

Central Contacts and Locations

Locations

Community Health Center of Franklin County

Recruiting

Greenfield, Massachusetts, United States, 01301

Contacts

More Information

Sponsor

Community Health Center of Franklin County

Last update posted

Jul 27, 2017

Last verified

Jul, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Community Health Center of Franklin County on 2017-07-27.