NCT06870526

Brief Summary

The goal of this study is to find ways to help families with children who have limited incomes get better access to healthy and culturally appropriate foods. The study will test a program called "medically tailored grocery box delivery," which sends boxes of healthy groceries to families based on their specific health needs. The study aims to answer:

  • Work with the community to design the grocery program and make sure the foods meet families' cultural preferences.
  • Test how well the program can be carried out in real-world settings.
  • Compare how the program affects families' access to healthy food, eating habits, and use of the grocery boxes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

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

First Submitted

Initial submission to the registry

January 17, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

May 13, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 17, 2025

Last Update Submit

January 30, 2026

Conditions

Keywords

GroceryFood delivery

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the FOODBOX pilot

    Grocery Box Delivery and Usage: Participants will receive grocery boxes containing a selection of fresh, frozen, or canned fruits, vegetables, legumes, whole grains, and low- sugar, low-fat snacks. Information regarding the receipt and utilization of grocery boxes will be collected, including delivery confirmation, redemption rates, and feedback on the quality and quantity of food items received. Participant Feedback and Satisfaction: Participants will have opportunities to provide feedback on the intervention materials, delivery process, and overall satisfaction with the program. This feedback may be collected through surveys, interviews, or focus groups conducted at various points during the intervention period.

    12 weeks

Secondary Outcomes (1)

  • Food Security

    12 weeks

Other Outcomes (1)

  • Fruit and Vegetable Intake

    12 weeks

Study Arms (1)

FoodBox

EXPERIMENTAL

Participants will receive a grocery box for 12 weeks. Participants will receive groceries that contain fresh, frozen, or canned fruits, vegetables, legumes, whole grains, and low-sugar low-fat snacks.

Behavioral: Food box delivery

Interventions

* Time Needed: 12 weeks (duration of intervention) * Description: Participants will receive grocery boxes containing a selection of food items tailored to their cultural and nutritional needs. They will be asked to utilize the groceries provided and provide feedback on the quality and quantity of items received. The pilot study will partner with Instacart, utilizing Instacart Care Carts for the "medically tailored grocery delivery" in which researchers order and deliver groceries on behalf of participants. Although families are not able to modify the order, they select when and where they want the grocery box delivered.

FoodBox

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Reside in low-income neighborhoods of the South Bronx, New York City.
  • Have children under the age of 10 in the household.
  • Primarily English or Spanish speakers.
  • Participating in the Supplemental Nutrition Assistance Program (SNAP) or meeting income criteria (\< 130% of the Federal Poverty Level).
  • Have access to online ordering through a smartphone or computer.

You may not qualify if:

  • Households residing outside the designated low-income neighborhoods of the South Bronx.
  • No children under the age of 10 in the household.
  • Unable to communicate in English or Spanish.
  • Not participating in SNAP or not meeting income criteria.
  • Lack access to online ordering through a smartphone or computer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronx Health REACH

New York, New York, 10035, United States

Location

Study Officials

  • Angela Trude, PhD

    New York University

    PRINCIPAL INVESTIGATOR
  • Roger Figueroa Baotista, PhD

    Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 17, 2025

First Posted

March 11, 2025

Study Start

May 13, 2025

Primary Completion

September 30, 2025

Study Completion

September 30, 2025

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations