Overweight and ObesityNCT03231592
Im(Proving) the CSA Model
A study testing CSA Group in people with Overweight and Obesity and Nutrition Poor, run by Community Health Center of Franklin County at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Nutrition Poor, Diet Modification
- What is being tested?
- CSA Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2017to 20 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Community Health Center of Franklin County
Greenfield, Massachusetts, 01301
Edward Sayer, 413-325-8500 ext. 108, edward.sayer@chcfc.org
Maegan Petrie, (413) 325-8500 ext. 128, Maegan.Petrie@chcfc.org
About this study
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).
Read the detailed description
Full study protocol is available upon request from Rochelle Bellin
- Conditions
- Overweight and Obesity, Nutrition Poor, Diet Modification
- Being tested
- CSA Group, Enhanced Usual Care Group
- Medical subject headings
- Overweight, Obesity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSA GroupOther
Already included in the arm descriptions.
Enhanced Usual Care GroupOther
Already included in the arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: CSA Group |
| 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. Receives: Other: Enhanced Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
HEI2010 Score
The HEI 2010 score is an indicator of dietary quality.
Measured: 19 months
Secondary outcomes (1)
Health Related Quality of Life
We will use the PROMIS-10 Global Health instrument to assess Health Related Quality of Life
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start10 May 2017
- Primary completion20 Dec 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Community Health Center of Franklin County
- Sponsor type
- University, hospital or other
- Collaborators
- Just Roots, Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Edward Sayer, Principal investigator, Community Health Center of Franklin County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231592
- Sponsor's protocol ID
- FMPP2016
- Status last verified
- Jul 2017
- First submitted
- 9 May 2017
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31522922
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Im(Proving) the CSA Model
- ClinicalTrials.gov ID
- NCT03231592
- Acronym / sponsor ID
- FMPP2016
- Conditions
- Overweight and Obesity, Nutrition Poor, Diet Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Community Health Center of Franklin CountyUniversity, hospital or other
- Collaborators
- Just Roots, Massachusetts General Hospital
- Study start
- 10 May 2017 (actual)
- Primary completion
- 20 Dec 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSA Group | Experimental | Other: CSA GroupThis 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. |
| Enhanced Usual Care Group | Active comparator | Other: Enhanced Usual Care GroupThis group will receive a handout about healthy eating, in addition to routine care in their primary care practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSA GroupAlready included in the arm descriptions. | Other | CSA Group |
| Enhanced Usual Care GroupAlready included in the arm descriptions. | Other | Enhanced Usual Care Group |
Primary outcome
HEI2010 Score
Time frame: 19 months
The HEI 2010 score is an indicator of dietary quality.
1 secondary outcome
Health Related Quality of Life
Time frame: 19 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Derived from this study: PubMed 31522922Berkowitz 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.
- 24-hour dietary recall tool to be used at each Research Visit to assess participants previous 24 hours of consumptionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Sayer principal investigator
Community Health Center of Franklin County
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSA Group in people with Overweight and Obesity and Nutrition Poor, run by Community Health Center of Franklin County at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rochelle Bellin ((413) 325-8969, rochelle@justroots.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HEI2010 Score (time frame: 19 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.