NCT05381766

Brief Summary

BASIS aims to implement a whole-of-community intervention in Brooklyn for improving diet and the social and /built environments for English-, Chinese-, Spanish-, and Bangla-speaking communities. This is achieved through five main pillars: by 1) improving food access (subsidized, culturally tailored fresh produce box program), 2) providing nutrition education, 3) conducting experiential learning (gardening workshops, cooking demonstrations, farm tours, physical activity sessions, arts-based sessions), 4) assisting with economic security (SNAP/WIC enrollment, workforce development, small business owner engagement), and 5) contributing to policy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,200

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress84%
Jun 2023Nov 2026

First Submitted

Initial submission to the registry

May 11, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 19, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

May 11, 2022

Last Update Submit

March 23, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Change in Fruit+Vegetable Intake as Measured by Skin Carotenoids

    Fruit and vegetable intake will be assessed by a composite measurement of skin carotenoids. Skin carotenoids are a biomarker of fruit and vegetable intake and will be measured using the Veggie Meter. The Veggie Meter is a non-invasive device about the size of a large stapler that plugs into the standard USB port of a laptop computer

    Baseline, Week 20

  • Change in Fruit+Vegetable Intake as Measured by Self-Report

    Self-report of fruit and vegetable intake will rely on food frequency-like questionnaires that will ask about amount and frequency of a list of common produce items (e.g., cucumbers, tomatoes) as well as specific produce items supplied in the BASIS produce box program. Fruit+vegetable intake is reported as a composite measure.

    Baseline, Week 20

  • Change in Neighborhood Social Cohesion

    Neighborhood social cohesion will be assessed using the 5-item scale developed by the Project on Human Development in Chicago Neighborhoods Community Survey. Participants may rate agreement/disagreement on a 5-point scale (scale: 1-strongly agree, 2-agree, 3-neutral, 4-disagree, 5-strongly disagree) with the following 5 statements: 1) People around here are willing to help their neighbors; 2) People in this neighborhood generally don't get along with each other; 3) People in this neighborhood can be trusted; 4) People in this neighborhood do not share the same values; and 5) Most people in this neighborhood know each other. Participant responses for questions 1, 3 and 5 will then be reverse coded (e.g., strongly agree was assigned a value of 5 instead of 1), such that a higher value was associated with a more positive response to each statement. The total score ranges from 5-25; higher scores indicate greater neighborhood social cohesion.

    Baseline, Week 20

  • Change in Sense of Belonging

    Sense of belonging will be measured using the 4-item Challenged Sense of Belonging Scale (CSBS). The CSBS is scored using a five-point Likert scale, where 1 indicates "strongly agree" and 5 indicates "strongly disagree". Each item on the scale is scored from 1 (low sense of belonging) to 5 (high sense of belonging). The total score is calculated by adding the manifest variables and dividing by the number of manifest variables, resulting in a score between 1 and 5; higher scores indicate a higher sense of belonging.

    Baseline, Week 20

  • Change in Ethnic Pride

    Ethnic pride will be measured using the 8-item Ethnic Affirmation and Belonging Scale. Items are scored on a 5-point Likert scale from 1-5. The total score is an average of the 8 item scores and ranges from 1-5; higher scores indicate greater ethnic pride.

    Baseline, Week 20

Secondary Outcomes (1)

  • Change in Cross-Cultural/Cross-Racial Understanding

    Baseline, Week 20

Study Arms (2)

Intervention Group - CSA Model

EXPERIMENTAL

English-, Chinese-, Spanish-, and Bangladeshi-speaking community members (adults 18+ years) residing in Sunset Park and surrounding neighborhoods will participate in a culturally adapted systems-level program for improving diet. The intervention will be evaluated through baseline and follow-up surveys and skin carotenoid assessments.

Other: CSA Model

Control Group

NO INTERVENTION

Mexican-identifying community members (adults 18+ years) residing in Mott Haven, Bronx and Chinese-identifying community members (adults 18+ years) residing in Chinatown, Manhattan and Flushing, Queens will form the comparison community. Recruited participants from the comparison communities will complete evaluation components (surveys and skin carotenoid assessments) but not receive the intervention.

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. Culturally appropriate produce will be provided weekly for 20 weeks to community members in Sunset Park and surrounding neighborhoods. Brooklyn Grange in Sunset Park will grow and provide Chinese specific produce for a fee ranging from $7 to $31 depending on the participant's self-identified situation and Angel Family Farm will grow and provide Mexican specific produce for a fee of up to $15. Participants that receive SNAP benefits can use their EBT card to cover their produce box fees. Education will be offered in the form of nutrition education, cooking tutorials, and farming information provided by staff at Brooklyn Grange.

Intervention Group - CSA Model

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • CSA:
  • Adult age 18 years and over
  • Resides in Zip codes: 11204, 11209, 11214, 11215, 11217, 11218, 11219, 11220, 11228, 11232
  • Speak English, Mandarin, Cantonese, Spanish, or Bangla
  • Willing and able to provide consent
  • Comparison Communities:
  • Adult age 18 years and over
  • Currently living in South Bronx (Zip codes 10454, 10455, 10451, 10456, 10459), Chinatown (Zip codes 10038, 10002, 10013, 10012), or Flushing (Zip codes 11354, 11355, 11356, 11357, 11360, 11359, 11358, 11365, 11367, 11368)
  • Speak English, Mandarin, Cantonese, or Spanish
  • Willing and able to provide consent

You may not qualify if:

  • Unable to complete the baseline survey in English, Mandarin, Cantonese, Spanish or Bangla

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Stella Yi, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2022

First Posted

May 19, 2022

Study Start

June 7, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, ICF
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. 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.

Locations