Harvest Share Clinical Outcomes

April 16, 2026 updated by: NYU Langone Health

Harvest Share Health Plus Pilot: Evaluating Clinical Outcomes of Participants in the Building Access to Food Through Systems and Solidarity (BASIS) Program

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Individuals who don't meet the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HS CSA Participants
Participants in study NCT05381766 who are enrolled in the fourth year (2026) of the CSA program.
Behavioral: Community Supported Agriculture (CSA)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol
Time Frame: Baseline, Post-Visit (approx. Week 18), Follow-Up Visit (approx. Week 40)
Assessed using standardized point-of-care cholesterol measurement procedures.
Baseline, Post-Visit (approx. Week 18), Follow-Up Visit (approx. Week 40)
Blood pressure (BP)
Time Frame: Baseline, Post-Visit (approx. Week 18), Follow-Up Visit (approx. Week 40)
Assessed using standardized point-of-care community BP measurement procedures.
Baseline, Post-Visit (approx. Week 18), Follow-Up Visit (approx. Week 40)
Dietary Inflammation
Time Frame: Baseline, Follow-Up Visit (approx. Week 40)
Assessed with 24-hour dietary recalls.
Baseline, Follow-Up Visit (approx. Week 40)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Stella Yi, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 18, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-00350
  • R01MD018204 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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