- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07729436
Healthy Options At Pantries (HOAP) Study (HOAP)
July 22, 2026 updated by: Jenny Jia, Northwestern University
Community-engaged Design and Implementation of a Behavioral Economics Food Choice Intervention in Food Pantries to Improve Cardiovascular Health
This study will evaluate a digital nudge intervention, Healthy Options At Pantries (HOAP), in the online food pantries of three large charitable food organizations.
The study will use a hybrid effectiveness-implementation design, meaning it will evaluate whether the intervention works and how it can best be rolled out in an online food pantry setting.
Intervention effectiveness will be evaluated using an interrupted time series analysis to identify changes in how healthy foods ordered by shoppers are (primary outcome) by comparing food ordering data over time before and after HOAP is introduced.
The study will also evaluate the possibility of collecting dietary and clinical outcomes in a small subgroup of online pantry shoppers over time comparing both in-person and at-home approaches.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This study will pilot and evaluate the Healthy Options At Pantries (HOAP) digital nudge intervention that was co-designed by pantry shoppers to encourage healthier food choices in online food pantries.
We will evaluate the preliminary effectiveness of HOAP using an interrupted time series (ITS) to determine if HOAP implementation is associated with healthier online pantry orders by shoppers across three community organizations who operate online food pantries.
The ITS analysis will compare 6 months of pre-intervention data to 6 months of during-intervention data to assess changes in food selection.
The primary outcome is the healthfulness of items ordered by shoppers.
In addition, we will qualitatively identify implementation factors that influence intervention success, including facilitators and barriers.
We will also assess the feasibility and acceptability of longitudinally collecting diet quality, blood pressure, body composition, and weight data in 30 pantry shoppers comparing in-person and remote approaches to data collection over a 6- to 12-month period.
Feasibility outcomes will include data completeness and acceptability of data collection procedures.
Study Type
Interventional
Enrollment (Estimated)
300
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 Contact
- Name: Emily Research Study Coordinator, MS
- Phone Number: 312-503-4917
- Email: emily.romero@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
Contact:
- Emily Research Study Coordinator, MS
- Phone Number: 312-503-4917
- Email: emily.romero@northwestern.edu
-
Principal Investigator:
- Jenny Jia, MD, MSc
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Eligibility Criteria:
- Adults age 18 years or older
- Speak English or Spanish
- Access to a smartphone
- Have ordered from the online food pantry at least half of the available times over the past 6 pantry eligible periods (for example, at least 3 times in the past 6 weeks for online food pantries that allow weekly ordering or at least 3 times in the past 6 months for online food pantries that allow monthly ordering), during the 6-month period prior to implementation of the HOAP program (i.e., months -6 to -1)
- Plan to continue ordering from the online food pantry for the next 6 months
Exclusion Criteria:
- Weigh more than 300 pounds
- Have a pacemaker, defibrillator, or other cardiac implant
- Plan to move out of metro Chicago in the next 6 months
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HOAP Intervention Cohort
Online pantry shoppers will receive the behavioral digital nudge intervention informed by the Healthy Eating Research guidelines.
Nudges include: 1) traffic light labeling of foods as green (choose often), yellow (choose sometimes), or orange (choose rarely) based on levels of saturated fat, sodium, and added sugar, displayed using colored dots and borders; 2) traffic light filters for food items; 3) choice architecture to display healthier items first; 4) a nutrition summary bar to display the number and proportion of items in cart by traffic light color; and 5) opt-out healthy default nudges styled as Healthy Bonus Items.
A subgroup of adult shoppers will participate in a feasibility study comparing in-person to remote collection of dietary and clinical outcomes.
Subgroup participants will complete ASA24 diet recalls and provide blood pressure, weight, and body composition measurements.
|
Behavioral: Behavioral economics-based Healthy Options At Pantries (HOAP) digital nudge intervention
Intervention will include behavioral digital nudges over a 6-month period to promote healthier food selection among online food pantry shoppers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Healthfulness of Shopper Food Selection
Time Frame: 6 months pre-intervention and 6 months post-intervention
|
The primary outcome is change in the healthfulness of shopper food selection over time, measured using the Charitable Food Network Index (CFNI).
At each time point, food orders will be categorized into proportions of green, yellow, and orange items based on the Healthy Eating Research (HER) guidelines.
These proportions will be combined into a composite CFNI score.
CFNI scores range from 0 to 100, with higher scores indicating healthier overall food selections.
|
6 months pre-intervention and 6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet quality
Time Frame: 3-6 months pre-intervention and 3-6 months post-intervention
|
Diet quality will be measured through up to two 24-hour dietary recalls using the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24).
|
3-6 months pre-intervention and 3-6 months post-intervention
|
|
Blood Pressure
Time Frame: 3-6 months pre-intervention and 3-6 months post-intervention
|
Blood pressure will be measured using an automated blood pressure cuff.
Blood pressure will be systolic and diastolic measures in mmHg.
At each collection point, three blood pressure measurements will be obtained, and the average of the second and third measurements will be used for analysis.
|
3-6 months pre-intervention and 3-6 months post-intervention
|
|
Body Weight
Time Frame: 3-6 months pre-intervention and 3-6 months post-intervention
|
Body weight will be measured in pounds using a medical-grade scale.
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3-6 months pre-intervention and 3-6 months post-intervention
|
|
Body Composition
Time Frame: 3-6 months pre-intervention and 3-6 months post-intervention
|
Body composition measures will include body fat percentage (range: 5-60%), visceral fat level (range: 1-30, lower values indicate lower visceral fat), and skeletal muscle percentage (range: 5-50%).
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3-6 months pre-intervention and 3-6 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jenny Jia, MD, MSc, Northwestern University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schwartz M, Levi R, Lott M, Arm K, Seligman H. Healthy Eating Research Nutrition Guidelines for the Charitable Food System. Healthy Eating Research. Accessed Oct 7, 2021. https://healthyeatingresearch.org/wp-content/uploads/2020/02/her-food-bank_FINAL.pdf
- Gombi-Vaca MF, Xu R, Schwartz M, Battista Hesse M, Martin K, Caspi CE. Validating a Nutrition Ranking System for Food Pantries Using the Healthy Eating Index-2015. Nutrients. 2022 Sep 21;14(19):3899. doi: 10.3390/nu14193899.
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 (Estimated)
August 1, 2026
Primary Completion (Estimated)
January 31, 2028
Study Completion (Estimated)
March 31, 2029
Study Registration Dates
First Submitted
July 22, 2026
First Submitted That Met QC Criteria
July 22, 2026
First Posted (Actual)
July 27, 2026
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
July 22, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00221030
- K23HL173655 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data that underlie the results of this study will be shared.
De-identified study data will be made available to the research community through the Inter-university Consortium for Political and Social Research (ICPSR), an open-access data repository.
IPD Sharing Time Frame
Shared data will be made available as soon as possible, and no later than the time of publication or the end of the funding period.
Data will be available for at least 7 years thereafter.
IPD Sharing Access Criteria
All de-identified study data will be made available through ICPSR as public-use data without restriction.
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.
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