NCT06298253

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,750

participants targeted

Target at P75+ for not_applicable

Timeline
26mo left

Started Oct 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress44%
Oct 2024Jun 2028

First Submitted

Initial submission to the registry

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

March 1, 2024

Last Update Submit

April 27, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pantry SWAP implementation

    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

    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

    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

    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 Outcomes (1)

  • Skin carotenoid level

    6 months and 12 months

Study Arms (2)

Behavioral economics-enhanced SWAP implementation strategy

EXPERIMENTAL

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.

Behavioral: Behavioral economics-enhanced SWAP implementation

Basic SWAP implementation strategy

ACTIVE COMPARATOR

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.

Behavioral: Basic SWAP implementation

Interventions

Intervention will include behavioral nudges at baseline and over 12 months to promote use of the SWAP nutrition program for pantries.

Behavioral economics-enhanced SWAP implementation strategy

Intervention will include basic information about the SWAP program and encouragement to obtain SWAP toolkits.

Basic SWAP implementation strategy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

  • Perez PD, Faulkner KC, Wu Y, Schwartz MB, Caspi C, Burgun R, Ortiz L, Jia J, Cheng J, Chang Y, Levy DE, Thorndike AN. Behavioural economics intervention to implement a nutrition ranking system in food pantries: Be Well cluster randomised controlled trial protocol. BMJ Public Health. 2025 Dec 30;3(2):e003650. doi: 10.1136/bmjph-2025-003650. eCollection 2025.

Study Officials

  • Anne N Thorndike, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne N Thorndike, MD, MPH

CONTACT

Douglas Levy, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 1, 2024

First Posted

March 7, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
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.

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