Diet HabitNCT06521411
Pilot Subsidized and Culturally-adapted Community Supported Agriculture (CSA) Program
A study testing CSA model in people with Diet Habit, run by NYU Langone Health at 1 site in United States.
Trial summary
This study aims to apply community-engaged methods to refine and implement a culturally adapted systems-level program for improving diet in low income, Chinese American immigrants. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Diet Habit
- What is being tested?
- CSA model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to 1 Nov 2022
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age 18 years and over
- Currently living in Brooklyn
- Willing and able to provide consent
Who cannot join
- Unable to complete the baseline survey in English, Mandarin, or Cantonese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of a Subsidized and Culturally-adapted Community Supported Agriculture (CSA) Program
This study aims to apply community-engaged methods to refine and implement a culturally adapted systems-level program for improving diet in low income, Chinese American immigrants. Guided by the regular partner engagement, The researchers have organically developed a systems-level program to bring a subsidized community-supported agriculture (CSA) model to the community in a way that is aligned with cultural values, and that includes culturally appropriate produce and nutrition education.
This is a single-site proof of concept pilot program that will be evaluated using a pre-post-design.
- Conditions
- Diet Habit
- Being tested
- CSA model
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSA modelBehavioural
Community-supported agriculture (CSA) involves a community of individuals who support a farm and in return receive distributions of the farm's produce throughout the growing season. Culturally appropriate produce will be provided in subsidized weekly boxes for 20 weeks to community members at Brooklyn Grange Farm in Sunset Park at a fee of $5, which was determined to be acceptable by community members. Participants that receive SNAP benefits can use their EBT card to cover their $5. Education will be offered in the form of nutrition education, cooking tutorials, and farming information provided by staff at Brooklyn Grange.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Low-income Chinese American immigrant families with a focus on adults 18+ years in Brooklyn will participate in a culturally adapted systems -level program for improving diet. Receives: Behavioral: CSA model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Number of Different Vegetables Consumed
Diet quality will be self-reported via a follow-up survey. The participant is presented with a list of 29 different vegetables - he/she is asked to select all of the vegetables in the list that was consumed in the past month.
Measured: Baseline, Week 20
Change in Diet Quality - Frequency
Diet quality will be self-reported via a follow-up survey. Frequency (how often vegetables were consumed in the past month) is reported on a Likert scale: 1 = once a month, 2 = two or three times a month, 3 = once a week, 4 = more than once a week.
Measured: Baseline, Week 20
Change in Diet Quality - Quantity of Serving
Diet quality will be self-reported via a follow-up survey. Quantity of Serving (how much is consumed at a time) is reported on a Likert Scale: 1 = less than ¼ cup, 2 = ¼ to ½ cup, and 3 = more than ½ cup.
Measured: Baseline, Week 20
Secondary outcomes (2)
Change in Food Insecurity Score
Food insecurity will be self-reported via a follow-up survey. The survey consists of 2 questions, reported on a Likert scale: 1 = often true, 2 = sometimes true, 3 = never true. The total range of score is 2-6; the higher the score, the lesser the insecurity.
Measured: Baseline, Week 20
Change in Social Cohesion Score
Social cohesion will be self-reported via a follow-up survey. The survey consists of 3 questions, reported on a Likert scale: 0 = often, 1 = some of the time, 2 = hardly ever, 3 = never. The total score range is 0-9; the higher the score, the greater the sense of social cohesion.
Measured: Baseline, Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start24 May 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stella Yi, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521411
- Sponsor's protocol ID
- 22-00229-0
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Stella.Yi@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Subsidized and Culturally-adapted Community Supported Agriculture (CSA) Program
- ClinicalTrials.gov ID
- NCT06521411
- Acronym / sponsor ID
- 22-00229-0
- Conditions
- Diet Habit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 26 Jul 2024 (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.
This study aims to apply community-engaged methods to refine and implement a culturally adapted systems-level program for improving diet in low income, Chinese American immigrants. Guided by the regular partner engagement, The researchers have organically developed a systems-level program to bring a subsidized community-supported agriculture (CSA) model to the community in a way that is aligned with cultural values, and that includes culturally appropriate produce and nutrition education.
This is a single-site proof of concept pilot program that will be evaluated using a pre-post-design.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: CSA modelLow-income Chinese American immigrant families with a focus on adults 18+ years in Brooklyn will participate in a culturally adapted systems -level program for improving diet. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age 18 years and over
- Currently living in Brooklyn
- Willing and able to provide consent
Key exclusion criteria (1 listed)
- Unable to complete the baseline survey in English, Mandarin, or Cantonese
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 modelCommunity-supported agriculture (CSA) involves a community of individuals who support a farm and in return receive distributions of the farm's produce throughout the growing season. Culturally appropriate produce will be provided in subsidized weekly boxes for 20 weeks to community members at Brooklyn Grange Farm in Sunset Park at a fee of $5, which was determined to be acceptable by community members. Participants that receive SNAP benefits can use their EBT card to cover their $5. Education will be offered in the form of nutrition education, cooking tutorials, and farming information provided by staff at Brooklyn Grange. | Behavioural | Study Group |
Primary outcome
Change in Number of Different Vegetables Consumed
Time frame: Baseline, Week 20
Diet quality will be self-reported via a follow-up survey. The participant is presented with a list of 29 different vegetables - he/she is asked to select all of the vegetables in the list that was consumed in the past month.
Change in Diet Quality - Frequency
Time frame: Baseline, Week 20
Diet quality will be self-reported via a follow-up survey. Frequency (how often vegetables were consumed in the past month) is reported on a Likert scale: 1 = once a month, 2 = two or three times a month, 3 = once a week, 4 = more than once a week.
Change in Diet Quality - Quantity of Serving
Time frame: Baseline, Week 20
Diet quality will be self-reported via a follow-up survey. Quantity of Serving (how much is consumed at a time) is reported on a Likert Scale: 1 = less than ¼ cup, 2 = ¼ to ½ cup, and 3 = more than ½ cup.
2 secondary outcomes
Change in Food Insecurity Score
Time frame: Baseline, Week 20
Change in Social Cohesion Score
Time frame: Baseline, Week 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Stella.Yi@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Stella Yi, MD principal investigator
NYU Langone Health
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 model in people with Diet Habit, run by NYU Langone Health 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 26 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Number of Different Vegetables Consumed (time frame: Baseline, Week 20). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2024.