Cardiometabolic DiseaseNCT07076251
Building Access to Food Through Systems and Solidarity (BASIS): A Subsidized and Culturally-adapted Produce Box Program for Immigrant Communities of Brooklyn, NY
A study testing Family Box program in people with Cardiometabolic Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this study is to improve diet and social cohesion among Chinese American families living in New York City (NYC) through a program that provides whole grains and legumes, builds ethnic identity, and fosters family resilience. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Disease
- What is being tested?
- Family Box program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-90 years
- Self-identify as Chinese or Chinese American
- Caretaker or parent of at least one child who lives with them between the ages of 2-6 years
- Willing and able to provide written consent
- Comfortable speaking English, Cantonese, or Mandarin; reading in English or simplified or traditional Chinese
- Can travel to CPC site for box pick-up monthly
Who cannot join
- 1. Individuals who don't meet the eligibility criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Access to Food Through Systems and Solidarity (BASIS): A Subsidized and Culturally-adapted Produce Box Program for Immigrant Communities of Brooklyn, NY - Family Box Pilot Study
The goal of this study is to improve diet and social cohesion among Chinese American families living in New York City (NYC) through a program that provides whole grains and legumes, builds ethnic identity, and fosters family resilience. The study ultimately aims to leverage this program to address cardiometabolic disease disparities in a culturally meaningful way.
Read the detailed description
The goal of this study is to improve diet and social cohesion among Chinese American families living in New York City (NYC). In this 12-month program, families will receive a box of whole grains and legumes, bilingual children's books (every other month), and nutrition education/recipes every month. This project is a partnership between NYU and 3 multisectoral organizations (i.e., a local farm, community-based organization, and bilingual book subscription company). The program will be evaluated using surveys at the beginning and end of the 12-month program. Through this pre-post evaluation, the investigators will evaluate the impact of the program on intake of whole grains and fruits and vegetables (inclusive of legumes). The study ultimately aims to leverage this program to address cardiometabolic disease disparities in a culturally meaningful way.
- Conditions
- Cardiometabolic Disease
- Being tested
- Family Box program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Box programOther
Boxes will include approximately five pounds of dry ingredients (e.g., whole grains, legumes, flour), which translates into about 40 servings of food for a family of four per month. Each ingredient box will include culturally relevant recipes and, six times out of the twelve boxes, include a culturally relevant book for the family's child/children.
| Study group | Role | What they receive |
|---|---|---|
| Chinese American families living in New York City (NYC) | Experimental | Participants will receive a box, once a month across one year for a total of 12 boxes, with culturally relevant ingredients, books, and educational materials. Receives: Other: Family Box program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily intake of whole grains (ounces/day) as assessed by the National Cancer Institute's (NCI) 26-item Dietary Screener Questionnaire (DSQ)
The National Cancer Institute's (NCI) 26-item Dietary Screener Questionnaire (DSQ) is a tool used to assess dietary intake. It focuses on the frequency of consumption of specific foods and beverages within the past month. The DSQ is designed to capture intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat.
Measured: Baseline, End of Intervention (~12 months)
Change in daily intake of fruits and vegetables (inclusive of legumes; cups/day) as assessed by the NCI 26-item DSQ
The NCI 26-item DSQ is a tool used to assess dietary intake. It focuses on the frequency of consumption of specific foods and beverages within the past month. The DSQ is designed to capture intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat.
Measured: Baseline, End of Intervention (~12 months)
Secondary outcomes (2)
Change in Family functioning score
Family functioning score will be assessed via self-report using a validated questionnaire about family interactions and dynamics.
Measured: Baseline, End of Intervention (~12 months)
Change in the percent of individuals who report that they have food insecurity
Outcome measure is assessed through a self-administered survey.
Measured: Baseline, End of Intervention (~12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start28 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic DiseaseStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Madison N LeCroy, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076251
- Sponsor's protocol ID
- 24-01962
- Other IDs
- R01MD018204
- Status last verified
- May 2026
- First submitted
- 14 Jul 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified IPD data will not be made available due to the following key reasons. First, the possibility of re-identification of participants if IPD were shared is more than minimal given the small sample size, community-based recruitment, and eligibility criteria. Participants have expressed heightened concerns about data security, and thus the study team will take efforts to protect participants by restricting access to their IPD. Secondly, data-sharing de-identified IPD is not included in the study's consent form, and re-consenting enrolled participants with this added stipulation would not be feasible.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Access to Food Through Systems and Solidarity (BASIS): A Subsidized and Culturally-adapted Produce Box Program for Immigrant Communities of Brooklyn, NY - Family Box Pilot Study
- ClinicalTrials.gov ID
- NCT07076251
- Acronym / sponsor ID
- 24-01962
- Conditions
- Cardiometabolic Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jul 2025 (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.
The goal of this study is to improve diet and social cohesion among Chinese American families living in New York City (NYC) through a program that provides whole grains and legumes, builds ethnic identity, and fosters family resilience. The study ultimately aims to leverage this program to address cardiometabolic disease disparities in a culturally meaningful way.
Detailed description
The goal of this study is to improve diet and social cohesion among Chinese American families living in New York City (NYC). In this 12-month program, families will receive a box of whole grains and legumes, bilingual children's books (every other month), and nutrition education/recipes every month. This project is a partnership between NYU and 3 multisectoral organizations (i.e., a local farm, community-based organization, and bilingual book subscription company). The program will be evaluated using surveys at the beginning and end of the 12-month program. Through this pre-post evaluation, the investigators will evaluate the impact of the program on intake of whole grains and fruits and vegetables (inclusive of legumes). The study ultimately aims to leverage this program to address cardiometabolic disease disparities in a culturally meaningful way.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese American families living in New York City (NYC) | Experimental | Other: Family Box programParticipants will receive a box, once a month across one year for a total of 12 boxes, with culturally relevant ingredients, books, and educational materials. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18-90 years
- Self-identify as Chinese or Chinese American
- Caretaker or parent of at least one child who lives with them between the ages of 2-6 years
- Willing and able to provide written consent
- Comfortable speaking English, Cantonese, or Mandarin; reading in English or simplified or traditional Chinese
Key exclusion criteria (1 listed)
- 1. Individuals who don't meet the eligibility criteria
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 |
|---|---|---|
| Family Box programBoxes will include approximately five pounds of dry ingredients (e.g., whole grains, legumes, flour), which translates into about 40 servings of food for a family of four per month. Each ingredient box will include culturally relevant recipes and, six times out of the twelve boxes, include a culturally relevant book for the family's child/children. | Other | Chinese American families living in New York City (NYC) |
Primary outcome
Change in daily intake of whole grains (ounces/day) as assessed by the National Cancer Institute's (NCI) 26-item Dietary Screener Questionnaire (DSQ)
Time frame: Baseline, End of Intervention (~12 months)
The National Cancer Institute's (NCI) 26-item Dietary Screener Questionnaire (DSQ) is a tool used to assess dietary intake. It focuses on the frequency of consumption of specific foods and beverages within the past month. The DSQ is designed to capture intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat.
Change in daily intake of fruits and vegetables (inclusive of legumes; cups/day) as assessed by the NCI 26-item DSQ
Time frame: Baseline, End of Intervention (~12 months)
The NCI 26-item DSQ is a tool used to assess dietary intake. It focuses on the frequency of consumption of specific foods and beverages within the past month. The DSQ is designed to capture intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat.
2 secondary outcomes
Change in Family functioning score
Time frame: Baseline, End of Intervention (~12 months)
Change in the percent of individuals who report that they have food insecurity
Time frame: Baseline, End of Intervention (~12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No. De-identified IPD data will not be made available due to the following key reasons. First, the possibility of re-identification of participants if IPD were shared is more than minimal given the small sample size, community-based recruitment, and eligibility criteria. Participants have expressed heightened concerns about data security, and thus the study team will take efforts to protect participants by restricting access to their IPD. Secondly, data-sharing de-identified IPD is not included in the study's consent form, and re-consenting enrolled participants with this added stipulation would not be feasible.
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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.
Madison N LeCroy, PhD 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 Family Box program in people with Cardiometabolic Disease, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 29 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
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 daily intake of whole grains (ounces/day) as assessed by the National Cancer Institute's (NCI) 26-item Dietary Screener Questionnaire (DSQ) (time frame: Baseline, End of Intervention (~12 months)). The study lists 2 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 29 May 2026.