- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05752721
Impact of Online Ordering on Low-Income Adults' Food Security in Online Food Pantry Settings
July 29, 2024 updated by: NYU Langone Health
The primary objectives of this study are to determine whether the transition to online ordering at a choice-based food pantry network influences food security status among low-income adults and determining whether there are differences in impact by age group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
204
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Study Population
Food pantry clients at food pantry sites within the Met Council Kosher Food Pantry Network, a network that contains 65 pantry partners and over 200 community partners in NYC.
Description
Inclusion Criteria:
- aged 18 years or older
- have visited a food pantry that either is or is not scheduled to transition to online ordering at least once
- have capacity and willingness to provide consent
- speaks English
Exclusion Criteria:
- aged less than 18 years
- have not visited a food pantry that either is or is not scheduled to transition to online ordering at least once
- does not speak English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Food Pantry Scheduled to Transition to Online Ordering
Low-income adults who have visited the food pantry that is scheduled to transition to online ordering at least once.
Participants will complete an in-person survey and a research assistant will record the food items they received in the relevant visit to the pantry.
After the transition to online ordering at the intervention food pantry, participants will again complete the survey.
Food selections for participants in the this arm will be accessible through the online ordering platform.
|
The intervention food pantry will transition to online ordering at least once.
|
|
No Intervention: Food Pantry NOT Scheduled to Transition to Online Ordering
Low-income adults who have visited the food pantry that is NOT scheduled to transition to online ordering at least once.
Participants will complete an in-person survey and a research assistant will record the food items they received in the relevant visit to the pantry.
After the transition to online ordering at the intervention food pantry, participants will again complete the survey.
Participants in this arm will record their food selections and send them to the study team.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
U.S. Household Food Security Survey Module: Six-Item Short Form Score
Time Frame: Baseline
|
6-item assessment of food security.
The total score ranges from 0-6, where: 5-6 = very low food security; 2-4 = low food security; and 0-1 = high or marginal food security.
|
Baseline
|
|
U.S. Household Food Security Survey Module: Six-Item Short Form Score
Time Frame: Month 8
|
6-item assessment of food security.
The total score ranges from 0-6, where: 5-6 = very low food security; 2-4 = low food security; and 0-1 = high or marginal food security.
|
Month 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Obtain Food From Food Pantry Per Visit
Time Frame: Baseline
|
Expressed in minutes.
|
Baseline
|
|
Time to Obtain Food From Food Pantry Per Visit
Time Frame: Month 8
|
Expressed in minutes.
|
Month 8
|
|
Composite Weekly Fruit & Vegetable Intake Score
Time Frame: Baseline
|
The Behavioral Risk Factor Surveillance System's 2017 six-item fruit and vegetable screener, where values correspond to the number of times a participant consumed fruits and vegetables per week as a composite score.
The total score ranges from 0 to infinity.
|
Baseline
|
|
Composite Weekly Fruit & Vegetable Intake Score
Time Frame: Month 8
|
The Behavioral Risk Factor Surveillance System's 2017 six-item fruit and vegetable screener, where values correspond to the number of times a participant consumed fruits and vegetables per week as a composite score.
The total score ranges from 0 to infinity.
|
Month 8
|
|
Center for Nutrition & Health Impact's Household Nutrition Security Survey Module: Four-Item Short Form Score
Time Frame: Baseline
|
4-item assessment of nutrition security.
The four items within the measure are scored from 0 (if the participant selects "Always") to 4 (if the participant selects "Never").
The total score is the average of the four item scores and ranges from 0-4; higher scores indicate greater nutrition security, and scores of 2 or below indicate "low" levels of nutrition security.
|
Baseline
|
|
Center for Nutrition & Health Impact's Household Nutrition Security Survey Module: Four-Item Short Form Score
Time Frame: Month 8
|
4-item assessment of nutrition security.
The four items within the measure are scored from 0 (if the participant selects "Always") to 4 (if the participant selects "Never").
The total score is the average of the four item scores and ranges from 0-4; higher scores indicate greater nutrition security, and scores of 2 or below indicate "low" levels of nutrition security.
|
Month 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pasquale Rummo, NYU Langone Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2023
Primary Completion (Actual)
December 15, 2023
Study Completion (Actual)
December 15, 2023
Study Registration Dates
First Submitted
February 21, 2023
First Submitted That Met QC Criteria
February 21, 2023
First Posted (Actual)
March 3, 2023
Study Record Updates
Last Update Posted (Actual)
August 20, 2024
Last Update Submitted That Met QC Criteria
July 29, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 22-01523
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
After 36 months the data will be available in NYU Langone's data warehouse but without investigator support other than deposited metadata.
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.
The informed consent form, clinical study report, and analytic code will also be shared.
IPD Sharing 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.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request.
Proposals may be submitted up to 36 months following article publication.
After 36 months the data will be available in NYU Langone's data warehouse but without investigator support other than deposited metadata.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.