NCT07548619

Brief Summary

This pilot study aims to assess the feasibility and acceptability of collecting clinical outcomes amongst Building Access to Food through System and Solidarity (BASIS) participants (s22-00299). BASIS aims to implement a whole-of-community intervention in Brooklyn for improving diet and the social and build environments for English-, Chinese-, and Spanish-speaking communities. BASIS is a single-site program that is being evaluated over a period of 4 years. Each year, culturally appropriate produce will be provided weekly in the form of community-supported agriculture for 20 weeks to community members in Sunset Park, Brooklyn and surrounding neighborhoods. Specifically, we aim to collect cholesterol, blood pressure (BP), and dietary inflammation measures to evaluate impacts of BASIS on clinical outcomes.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 23, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

May 18, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Cholesterol

    Assessed using standardized point-of-care cholesterol measurement procedures.

    Baseline, Post-Visit (approx. Week 18), Follow-Up Visit (approx. Week 40)

  • Blood pressure (BP)

    Assessed using standardized point-of-care community BP measurement procedures.

    Baseline, Post-Visit (approx. Week 18), Follow-Up Visit (approx. Week 40)

  • Dietary Inflammation

    Assessed with 24-hour dietary recalls.

    Baseline, Follow-Up Visit (approx. Week 40)

Study Arms (1)

HS CSA Participants

EXPERIMENTAL

Participants in study NCT05381766 who are enrolled in the fourth year (2026) of the CSA program.

Behavioral: Community Supported Agriculture (CSA)

Interventions

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.

HS CSA Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult age 18 years and over
  • Participates in the Harvest Share CSA program
  • Speaks English, Chinese, or Spanish
  • Willing and able to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Stella Yi, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 23, 2026

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Stella.Yi@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Stella.Yi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.