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Food InsecurityFOODBOXNCT06870526

Feasibility of Online-supported Delivery Bringing Optimal Nutrition to Diverse Low-income Households With Children

A study testing Food box delivery in people with Food Insecurity, run by Cornell University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Food Insecurity
What is being tested?
Food box delivery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
13 May 2025to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Bronx Health REACH

    New York, New York, 10035

Other trials in United States

About this study

Official title: Program Evaluation of FOODBOX: "Feasibility of Online-supported Delivery Bringing Optimal Nutrition to Diverse Low-income Households With Children

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:

Read more
  1. Can this grocery delivery program improve families' access to healthy foods and support better eating habits?
  2. Will families use the groceries provided, and how effective is the program overall?

To answer these questions, researchers will:

  • 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.
Read the detailed description

The overarching goal of this project is to address nutrition insecurity among diverse low-income households with children by designing and piloting an intervention strategy grounded in Food Is Medicine (FIM). Leveraging existing online grocery technology, this project seeks to enhance nutrition security through a "medically tailored grocery box delivery" program. We aim to: 1) conduct formative research with a community engagement process to inform the intervention design and ensure foods are culturally acceptable and appropriate; 2) apply implementation strategies to assess the extent to which the intervention can be implemented in the intended setting exactly as evaluated; 3) compare preliminary efficacy of the program on nutrition security, dietary intake, and redemption rate.

Target Population: The study will be conducted in low-income, diverse neighborhoods of New York City, specifically in the South Bronx. Selection of the community was based on the highest poverty levels, chronic disease prevalence, and ethnic diversity. The target population includes households with young children (< age 10) at risk for food insecurity, primarily English or Spanish speakers, participating in SNAP or meeting income criteria < 130% FPL), and access to online ordering through a smartphone or computer.

Approach: Recruitment will be conducted at Bronx Health REACH, a community-based organization located in the South Bronx that serves residents of low-income and SNAP-eligible participants. SNAP-Ed provider and researchers will build the grocery box using Instacart. We will interview the provider to elicit barriers and opportunities for improvement and scalability of the program in other community settings. The formative research plan for the pilot study includes the incorporation of two focus groups at the beginning and end of the intervention, each comprising 10-12 participants. 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.

A total of 30 households will be selected for the program and will receive the 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. Evaluation of the intervention will encompass a comprehensive assessment of household nutrition security and dietary intake among children and caregivers. Pre- and post-assessments will evaluate household nutrition security, and diet intake among children and their caregivers using 24-hour recalls and veggie meter assessments. Additionally, SNAP-ED providers will be interviewed to gather insights into their experiences with program delivery and the utilization of Instacart for grocery box orders. A benchmark (i.e., minimum acceptable values) will be set a priori for feasibility (i.e., recruitment, randomization, intervention fidelity, and retention rates) and acceptability following the RE-AIM framework. Instacart data will track orders, deliveries, and confirmations to assess redemption rates. Acceptability will be assessed as participant satisfaction with the intervention materials. To evaluate preliminary efficacy, linear mixed-effects models with random effects to account for repeated caregiver measures will be used.

Conditions
Food Insecurity
Being tested
Food box delivery
Keywords
Grocery, Food delivery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Food box deliveryBehavioural

    • 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.
Study groups in NCT06870526
Study groupRoleWhat they receive
FoodBoxExperimentalParticipants 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.
Receives: Behavioral: Food box delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 weeks

Secondary outcomes (1)
  1. Food Security

    We will use the 18-item USDA Household Food Security Module to assess food security of families. This is a three-stage design with screeners. Screening keeps respondent burden to the minimum needed to get reliable data. Most households in a general population survey are asked only three questions (five if there are children in the household).

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study start13 May 2025
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Behavioral intervention
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06870526
Sponsor's protocol ID
IRB0010546
Acronym
FOODBOX
Status last verified
Jan 2026
First submitted
17 Jan 2025
Last updated
3 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Food box delivery in people with Food Insecurity, run by Cornell University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of the FOODBOX pilot (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.

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