跳至主要内容
临床试验/NCT03231592
NCT03231592Unknown不适用

Im(Proving) the CSA Model

Community Health Center of Franklin County2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2017年5月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
2
主要终点
HEI2010 Score

研究概览

简要总结

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).

详细描述

Full study protocol is available upon request from Rochelle Bellin

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: CSA Group (Other)

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.

干预措施: Enhanced Usual Care Group (Other)

结局指标

主要结局

HEI2010 Score

时间窗: 19 months

The HEI 2010 score is an indicator of dietary quality.

次要结局

  • Health Related Quality of Life(19 months)

研究者

发起方
Community Health Center of Franklin County
申办方类型
Other
责任方
Sponsor

研究点 (2)

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