Diet Modification, Nutrition Poor, Overweight and Obesity
Conditions
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
Interventions
OTHERCSA Group
Already included in the arm descriptions.
Already included in the arm descriptions.
Sponsors
Just Roots
Massachusetts General Hospital
Community Health Center of Franklin County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HEI2010 Score | 19 months | The HEI 2010 score is an indicator of dietary quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health Related Quality of Life | 19 months | We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 19 months | Systolic and Diastolic Blood Pressure. This is an exploratory outcome and the study is not necessarily powered to detect changes |
| Hemoglobin A1c | 19 months | Hemoglobin A1c. This is an exploratory outcome and the study is not necessarily powered to detect changes |
| Lipids | 19 months | 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 |
| Food Insecurity | 19 months | 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 |
| Estimate the return on investment of CSA membership | 19 months | 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. |
| Depressive Symptoms | 19 months | 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 |
| Cost Related Medication Underuse | 19 months | 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 |
| Food-Medication Trade-Offs | 19 months | 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 |
| Anxiety Symptoms | 19 months | 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 |
| BMI | 19 months | Body Mass Index. This is an exploratory outcome and the study is not necessarily powered to detect changes |
Countries
United States
Contacts
Primary ContactRochelle Bellin
Backup ContactEdward Sayer
Outcome results
None listed