NCT07076251

Brief Summary

The goal of this study is to improve diet and social cohesion among Chinese American families living in New York City (NYC) through a program that provides whole grains and legumes, builds ethnic identity, and fosters family resilience. The study ultimately aims to leverage this program to address cardiometabolic disease disparities in a culturally meaningful way.

Trial Health

57
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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2025

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 Start

First participant enrolled

April 28, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 14, 2025

Last Update Submit

July 21, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in daily intake of whole grains (ounces/day) as assessed by the National Cancer Institute's (NCI) 26-item Dietary Screener Questionnaire (DSQ)

    The National Cancer Institute's (NCI) 26-item Dietary Screener Questionnaire (DSQ) is a tool used to assess dietary intake. It focuses on the frequency of consumption of specific foods and beverages within the past month. The DSQ is designed to capture intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat.

    Baseline, End of Intervention (~12 months)

  • Change in daily intake of fruits and vegetables (inclusive of legumes; cups/day) as assessed by the NCI 26-item DSQ

    The NCI 26-item DSQ is a tool used to assess dietary intake. It focuses on the frequency of consumption of specific foods and beverages within the past month. The DSQ is designed to capture intakes of fruits and vegetables, dairy/calcium, added sugars, whole grains/fiber, red meat, and processed meat.

    Baseline, End of Intervention (~12 months)

Secondary Outcomes (2)

  • Change in Family functioning score

    Baseline, End of Intervention (~12 months)

  • Change in the percent of individuals who report that they have food insecurity

    Baseline, End of Intervention (~12 months)

Study Arms (1)

Chinese American families living in New York City (NYC)

EXPERIMENTAL

Participants will receive a box, once a month across one year for a total of 12 boxes, with culturally relevant ingredients, books, and educational materials.

Other: Family Box program

Interventions

Boxes will include approximately five pounds of dry ingredients (e.g., whole grains, legumes, flour), which translates into about 40 servings of food for a family of four per month. Each ingredient box will include culturally relevant recipes and, six times out of the twelve boxes, include a culturally relevant book for the family's child/children.

Chinese American families living in New York City (NYC)

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-90 years
  • Self-identify as Chinese or Chinese American
  • Caretaker or parent of at least one child who lives with them between the ages of 2-6 years
  • Willing and able to provide written consent
  • Comfortable speaking English, Cantonese, or Mandarin; reading in English or simplified or traditional Chinese
  • Can travel to CPC site for box pick-up monthly

You may not qualify if:

  • \. Individuals who don't meet the eligibility criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

  • Madison N LeCroy, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Madison N LeCroy, PhD

CONTACT

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 14, 2025

First Posted

July 22, 2025

Study Start

April 28, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

De-identified IPD data will not be made available due to the following key reasons. First, the possibility of re-identification of participants if IPD were shared is more than minimal given the small sample size, community-based recruitment, and eligibility criteria. Participants have expressed heightened concerns about data security, and thus the study team will take efforts to protect participants by restricting access to their IPD. Secondly, data-sharing de-identified IPD is not included in the study's consent form, and re-consenting enrolled participants with this added stipulation would not be feasible.

Locations