Clinical trial NCT03231592: Im(Proving) the CSA Model
Official title: Im(Proving) the CSA Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Nutrition Poor
Diet Modification
Lead sponsor: Community Health Center of Franklin County
Sponsor class: OTHER
Collaborators: name: Just Roots
name: Massachusetts General Hospital
First posted: 2017-07-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: HEI2010 Score
timeFrame: 19 months
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: 19 months
Other outcomes:
measure: Estimate the return on investment of CSA membership
timeFrame: 19 months
measure: BMI
timeFrame: 19 months
measure: Blood Pressure
timeFrame: 19 months
measure: Hemoglobin A1c
timeFrame: 19 months
measure: Lipids
timeFrame: 19 months
measure: Food Insecurity
timeFrame: 19 months
measure: Anxiety Symptoms
timeFrame: 19 months
measure: Depressive Symptoms
timeFrame: 19 months
measure: Cost Related Medication Underuse
timeFrame: 19 months
measure: Food-Medication Trade-Offs
timeFrame: 19 months
Locations:
city: Greenfield
country: United States
facility: Community Health Center of Franklin County
state: Massachusetts
Study officials:
affiliation: Community Health Center of Franklin County
name: Edward Sayer
role: PRINCIPAL_INVESTIGATOR
References:
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.