Harvest Share Clinical Outcomes
Harvest Share Health Plus Pilot: Evaluating Clinical Outcomes of Participants in the Building Access to Food Through Systems and Solidarity (BASIS) Program
2 other identifiers
interventional
75
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2026
CompletedFirst Posted
Study publicly available on registry
April 23, 2026
CompletedStudy Start
First participant enrolled
May 18, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2027
Study Completion
Last participant's last visit for all outcomes
February 28, 2027
April 23, 2026
April 1, 2026
10 months
April 16, 2026
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
EXPERIMENTALParticipants in study NCT05381766 who are enrolled in the fourth year (2026) of the CSA program.
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.
Eligibility Criteria
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
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stella Yi, PhD
NYU Langone Health
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
- 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.
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.