A Trial of Behavioral Economic Interventions Among Food Pantry Clients

February 4, 2024 updated by: Christina Roberto, Abramson Cancer Center at Penn Medicine

A Randomized Trial of Web-based Behavioral Economic Interventions to Promote Healthy Food Choices Among Food Pantry Clients

Obesity, unhealthy dietary habits, and food insecurity are major public health concerns, especially affecting individuals living in poverty. Food pantries, which provide free food to those in need, are increasingly interested in promoting healthy choices, but few rigorous studies have tested healthy eating interventions in food pantry settings. The overall objective of this proposal is to conduct a randomized-controlled trial among 500 regular food pantry clients to compare the influence of a behavioral economic intervention to promote healthier food choices delivered via a web-based ordering platform to usual care (control group).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The primary objective of this proposal is to evaluate the influence of a web-based behavioral economic intervention compared to a control group on the following outcomes among food pantry clients: 1) Nutritional quality of food chosen at the pantry using food transaction data; 2) Fruit and vegetable intake measured by biomarkers and food frequency questionnaires; 3) Objectively measured biomarkers of health. The web-based behavioral economic intervention will include the following modifications to the online shopping platform: 1) Healthy food shopping cart defaults, 2) healthy placement choice architecture, 3) traffic light nutrition labels, 4) social norms messaging, and 5) healthy swaps. Food transaction data will be collected from the online system at baseline and then continuously for the remaining 3 months of the study (participants typically shop monthly). Surveys and objective biomarkers will be collected at baseline and three-months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • ≥18 years old
  • primary grocery shopper for the family
  • a regular in-person client at the food pantry (i.e., shops at pantry ≥ 1 per month)
  • able to use the web-based touchscreen ordering system
  • able to use a blood pressure cuff and scale provided to them for taking blood pressure and weight
  • able to come outside their home for 5 minutes for the Veggie Meter measurement

Exclusion Criteria:

  • <18 years old
  • not the primary grocery shopper for the family
  • not a regular client at the food pantry (i.e., shops at pantry < 1 per month)
  • not able to use the web-based touchscreen ordering system
  • not able to use a blood pressure cuff and scale provided to them for taking blood pressure and weight
  • not able to come outside their home for 5 minutes for the Veggie Meter measurement

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: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control Group
Participants in this arm will view the typical web-based ordering system platform (usual care group).
Experimental: Behavioral Economic Intervention Group
Participants in this arm will be exposed to the web-based ordering system with multiple behavioral economic interventions applied, including healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
Behavioral: Behavioral economic intervention of online purchasing at a food pantry
This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Monthly Change in Number of Units of Healthier Foods
Time Frame: Collected from the online system at baseline and then each month for the remaining 3 months of participation.
Average monthly change from baseline across 3 months of participation, in number of units of healthier foods (labeled with a green traffic light) purchased per shopping trip using the food pantry's definition of a unit.
Collected from the online system at baseline and then each month for the remaining 3 months of participation.
Mean Monthly Change in Number of Units of Less Healthy Foods
Time Frame: Collected from the online system at baseline and then each month for the remaining 3 months of participation.
Average monthly change from baseline across 3 months of participation, in number of units of less healthy foods (labeled with a red or yellow traffic light) purchased per shopping trip using the food pantry's definition of a unit.
Collected from the online system at baseline and then each month for the remaining 3 months of participation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Body Mass Index (BMI)
Time Frame: Assessed at baseline and 3 months.
Change from baseline in BMI (weight in kg / height in meters^2)
Assessed at baseline and 3 months.
Mean Monthly Change in Calories From Healthier Foods Per Shopping Trip
Time Frame: Collected from the online system at baseline and then each month for the remaining 3 months of participation.
Average monthly change from baseline across 3 months of participation, in number of calories from healthier foods per shopping trip.
Collected from the online system at baseline and then each month for the remaining 3 months of participation.
Mean Monthly Change in Calories From Less Healthy Foods Per Shopping Trip
Time Frame: Collected from the online system at baseline and then each month for the remaining 3 months of participation.
Average monthly change from baseline across 3 months of participation, in number of calories from less healthy foods per shopping trip.
Collected from the online system at baseline and then each month for the remaining 3 months of participation.
Self-reported Change in Fruit and Vegetable Intake
Time Frame: Assessed at baseline and 3 months.
Change from baseline in fruit and vegetable intake as measured by the National Cancer Institute (NCI)'s fruit and vegetable module of the Dietary Screener Questionnaire in the National Health and Nutrition Examination Survey (NHANES). Scores estimate average daily cup equivalents of total fruit and vegetable servings.
Assessed at baseline and 3 months.
Biomarker Change in Fruit and Vegetable Intake
Time Frame: Assessed at baseline and 3 months.
Change from baseline in carotenoid levels (scores range 0-800) as measured by the VeggieMeter®. The VeggieMeter® is a spectroscopy-based skin carotenoid measurement device, created by Longevity Link Corporation in 2015. It uses pressure-mediated reflection spectroscopy (RS) to detect and quantify skin carotenoids as a proxy for fruit and vegetable intake in humans. Validation studies show VeggieMeter scores to be highly correlated with blood serum measures of carotenoids (R=.81). Higher units represent a higher concentration of carotenoids in the skin.
Assessed at baseline and 3 months.
Change in Systolic Blood Pressure
Time Frame: Assessed at baseline and 3 months.
Change from baseline in systolic blood pressure (indicator of heart health)
Assessed at baseline and 3 months.
Change in Diastolic Blood Pressure
Time Frame: Assessed at baseline and 3 months.
Change from baseline in diastolic blood pressure (indicator of heart health)
Assessed at baseline and 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abramson Cancer Center at Penn Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Massachusetts General Hospital
University of Connecticut

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina A Roberto, PhD, University of Pennsylvania

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UPCC 06022
  • R01CA229502 (U.S. NIH Grant/Contract)
  • 829702 (Other Identifier: IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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