NCT06521411

Brief Summary

This study aims to apply community-engaged methods to refine and implement a culturally adapted systems-level program for improving diet in low income, Chinese American immigrants. Guided by the regular partner engagement, The researchers have organically developed a systems-level program to bring a subsidized community-supported agriculture (CSA) model to the community in a way that is aligned with cultural values, and that includes culturally appropriate produce and nutrition education. This is a single-site proof of concept pilot program that will be evaluated using a pre-post-design.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 24, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 22, 2024

Last Update Submit

July 24, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Number of Different Vegetables Consumed

    Diet quality will be self-reported via a follow-up survey. The participant is presented with a list of 29 different vegetables - he/she is asked to select all of the vegetables in the list that was consumed in the past month.

    Baseline, Week 20

  • Change in Diet Quality - Frequency

    Diet quality will be self-reported via a follow-up survey. Frequency (how often vegetables were consumed in the past month) is reported on a Likert scale: 1 = once a month, 2 = two or three times a month, 3 = once a week, 4 = more than once a week.

    Baseline, Week 20

  • Change in Diet Quality - Quantity of Serving

    Diet quality will be self-reported via a follow-up survey. Quantity of Serving (how much is consumed at a time) is reported on a Likert Scale: 1 = less than ¼ cup, 2 = ¼ to ½ cup, and 3 = more than ½ cup.

    Baseline, Week 20

Secondary Outcomes (2)

  • Change in Food Insecurity Score

    Baseline, Week 20

  • Change in Social Cohesion Score

    Baseline, Week 20

Study Arms (1)

Study Group

EXPERIMENTAL

Low-income Chinese American immigrant families with a focus on adults 18+ years in Brooklyn will participate in a culturally adapted systems -level program for improving diet.

Behavioral: CSA model

Interventions

CSA modelBEHAVIORAL

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 in subsidized weekly boxes for 20 weeks to community members at Brooklyn Grange Farm in Sunset Park at a fee of $5, which was determined to be acceptable by community members. Participants that receive SNAP benefits can use their EBT card to cover their $5. Education will be offered in the form of nutrition education, cooking tutorials, and farming information provided by staff at Brooklyn Grange.

Study Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult age 18 years and over
  • Currently living in Brooklyn
  • Willing and able to provide consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Study Officials

  • Stella Yi, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

May 24, 2022

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Stella.Yi@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Shared Documents
STUDY PROTOCOL, SAP, 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 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.

Locations