Im(Proving) the CSA Model

Overweight and Obesity Clinical Trial

Official title:

Im(Proving) the CSA Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231592
• Other study ID #: FMPP2016
• Status: Recruiting
• Phase: N/A
• First received: May 9, 2017
• Last updated: July 24, 2017
• Start date: May 10, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: July 2017
• Source: Community Health Center of Franklin County
• Contact: Rochelle Bellin
• Phone: (413) 325-8969
• Email: rochelle[@]justroots.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

Full study protocol is available upon request from Rochelle Bellin

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 20, 2018
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet Modification
• Malnutrition
• Nutrition Poor
• Overweight
• Overweight and Obesity

Intervention

Other:
• CSA Group
Already included in the arm descriptions.
• Enhanced Usual Care Group
Already included in the arm descriptions.

Locations

Country	Name	City	State
United States	Community Health Center of Franklin County	Greenfield	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Community Health Center of Franklin County	Just Roots, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimate the return on investment of CSA membership	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
Other	BMI	Body Mass Index. This is an exploratory outcome and the study is not necessarily powered to detect changes	19 months
Other	Blood Pressure	Systolic and Diastolic Blood Pressure. This is an exploratory outcome and the study is not necessarily powered to detect changes	19 months
Other	Hemoglobin A1c	Hemoglobin A1c. This is an exploratory outcome and the study is not necessarily powered to detect changes	19 months
Other	Lipids	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
Other	Food Insecurity	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
Other	Anxiety Symptoms	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
Other	Depressive Symptoms	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
Other	Cost Related Medication Underuse	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
Other	Food-Medication Trade-Offs	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
Primary	HEI2010 Score	The HEI 2010 score is an indicator of dietary quality.	19 months
Secondary	Health Related Quality of Life	We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life	19 months

External Links

•   24-hour dietary recall tool to be used at each Research Visit to assess participants previous 24 hours of consumption