- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06298253
Behavioral Economics to Implement a Traffic Light Nutrition Ranking System: Study 2 (BeWell)
April 27, 2025 updated by: Anne N. Thorndike, MD, MPH, Massachusetts General Hospital
Behavioral Economics to Implement a Traffic Light Nutrition Ranking System in a Network of Food Pantries: Study 2
This is a cluster randomized controlled trial of 30 food pantries affiliated with the Greater Boston Food Bank to test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of fostering accurate use of SWAP traffic light labels on pantry shelves and increasing the healthfulness of foods chosen by pantry clients.
Primary outcomes will be assessed at 6 and 12 months to compare the implementation and effectiveness of the SWAP program in the intervention vs. control pantries.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This study will test the use of behavioral economics (BE) tools to encourage food pantries to implement the Supporting Wellness at Pantries (SWAP) program, with the goal of encouraging pantries to use SWAP traffic light labels on pantry shelves and increase the healthfulness of foods chosen by pantry clients.
The study design is a 12-month cluster RCT of 30 Greater Boston Food Bank partner pantries comparing a basic SWAP implementation strategy (control, n=15) with a BE-enhanced SWAP implementation strategy (intervention, n=15).
Primary outcomes assessed at 6 and 12 months will be implementation of the SWAP program within pantries and improvement of client food choices and dietary quality.
At the end of 12 months, the BE-enhanced SWAP implementation strategy will be adapted, updated, and offered to the 15 pantries assigned to control (waitlist) at baseline.
The 15 intervention pantries will be followed without further intervention.
Study Type
Interventional
Enrollment (Estimated)
3750
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: Douglas Levy, PhD
- Phone Number: 617-643-3595
- Email: dlevy3@mgh.harvard.edu
Study Contact Backup
- Name: Anne N Thorndike, MD, MPH
- Phone Number: 617-724-4608
- Email: athorndike@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Anne Thorndike, MD, MPH
- Phone Number: 617-724-4608
- Email: athorndike@mgh.harvard.edu
-
Contact:
- Douglas Levy, PhD
- Phone Number: 617-643-3595
- Email: dlevy3@mgh.harvard.edu
-
Principal Investigator:
- Anne Thorndike, MD, MPH
-
Principal Investigator:
- Douglas Levy, PhD
-
-
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
Inclusion Criteria:
- Food pantries enrolled in the study will be partner agencies of the Greater Boston Food Bank that are maximum client choice, are located within approximately 1 hour driving time of Boston (for logistical feasibility), and are not actively using traffic-light nutrition ranking.
- Food pantry clients that complete assessments must be 18 years or older and speak English or Spanish.
Exclusion Criteria:
- Food pantries that are not affiliated with the Greater Boston Food Bank and are not maximum client choice.
- Food pantry clients that do not speak English or Spanish.
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: Behavioral economics-enhanced SWAP implementation strategy
Pantries assigned to the intervention group will receive behavioral nudges for implementing the SWAP nutrition program.
These include: 1) invoice labeling with the food labeled as red, yellow, or green; 2) receipt of the SWAP toolkit at no cost; 3) pantry learning communities; 4)incentives to purchase SWAP implementation materials (e.g., shelves); 5) food bank recognition for SWAP implementation.
|
Intervention will include behavioral nudges at baseline and over 12 months to promote use of the SWAP nutrition program for pantries.
|
|
Active Comparator: Basic SWAP implementation strategy
Pantries assigned to the control arm will receive email communication from the food bank dietitian providing them with information about SWAP, online links to SWAP implementation guides, and encouragement to purchase SWAP Toolkits on their own.
|
Intervention will include basic information about the SWAP program and encouragement to obtain SWAP toolkits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pantry SWAP implementation
Time Frame: 6 months and 12 months
|
Proportion of pantries in the intervention vs. control group that implement SWAP (e.g., traffic-light labels on shelves)
|
6 months and 12 months
|
|
Percent items (by weight) ordered by pantry that are labeled green or red
Time Frame: 6 months and 12 months
|
Using data collected from the food bank ordering platform, this outcome will be the proportions (by weight) of the overall orders from GBFB that are green-labeled and red-labeled according to SWAP ranking categories
|
6 months and 12 months
|
|
Percent of pantry clients' selected food that is green or red
Time Frame: 6 months and 12 months
|
Using pantry client basket assessments, the total proportion (by weight) of food selected by the client that is labeled green (or red) will be calculated for each participant
|
6 months and 12 months
|
|
Client dietary quality score
Time Frame: 6 months and 12 months
|
Rapid Prime Dietary Quality Score (range 0 to 52, higher is healthier) collected at the time clients are leaving the pantry
|
6 months and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin carotenoid level
Time Frame: 6 months and 12 months
|
Measured using the Veggie Meter scale at the time clients leave the pantry; range is 0 to 800 units, with higher scores indicating higher carotenoid levels (and therefore higher fruit and vegetable intake)
|
6 months and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anne N Thorndike, MD, MPH, Massachusetts General Hospital
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)
October 1, 2024
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
March 1, 2024
First Submitted That Met QC Criteria
March 1, 2024
First Posted (Actual)
March 7, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2025
Last Update Submitted That Met QC Criteria
April 27, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2024P000832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data collected from pantry client assessments at baseline, 6 months, and 12 months will be shared.
This includes de-identified survey data, including dietary score data, client basket data with food identified as green, yellow, or red-labeled, and skin carotenoid levels.
De-identified and aggregated food pantry ordering data, which is secondary data collected from the food bank ordering, will also be shared.
The data and details related to our analytic plan and study measures will be deposited in a publicly accessible data repository, such as the Harvard Dataverse, a NIH-approved Scientific Generalist Data Repository free to researchers inside and outside of the Harvard community.
IPD Sharing Time Frame
Analytic plans and details will be made available no later than the official publication date of a peer-reviewed article and will be available for at least five years after the study period ends.
De-identified data from the study will be made publicly available through the data repository within 90 days of the closeout of the project and made available according to the Harvard Dataverse's data retention policy.
Additionally, data for each publication will be deposited by the time of publication.
IPD Sharing Access Criteria
In accordance with the data repository methods, completion of a data use agreement form, that stipulates data sharing under an IRB-approved protocol, will be required for accessing the data.
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
product manufactured in and exported from the U.S.
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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