NCT04011384

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

July 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 29, 2024

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

July 5, 2019

Results QC Date

December 22, 2023

Last Update Submit

February 4, 2024

Conditions

Keywords

Food AssistanceEconomics, BehavioralFood LabelingDiet RecordsBiomarkers

Outcome Measures

Primary Outcomes (2)

  • Mean Monthly Change in Number of Units of Healthier Foods

    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

    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 Outcomes (7)

  • Mean Monthly Change in 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

    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

    Assessed at baseline and 3 months.

  • Biomarker Change in Fruit and Vegetable Intake

    Assessed at baseline and 3 months.

  • Change in Body Mass Index (BMI)

    Assessed at baseline and 3 months.

  • +2 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Participants in this arm will view the typical web-based ordering system platform (usual care group).

Behavioral Economic Intervention Group

EXPERIMENTAL

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

Interventions

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.

Behavioral Economic Intervention Group

Eligibility Criteria

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

You may qualify if:

  • ≥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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Food PreferencesBehavior

Condition Hierarchy (Ancestors)

Feeding Behavior

Limitations and Caveats

Recruiting and assessing measurements (height, weight, blood pressure, and carotenoid levels) in person were limited by the onset of the Covid-19 pandemic in the middle of the study. In addition, monthly food pantry use was certainly impacted by the pandemic as well.

Results Point of Contact

Title
Dr. Laura Gibson
Organization
University of Pennsylvania

Study Officials

  • Christina A Roberto, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The research team will create the randomization list and a research assistant will assign the participant to the correct online platform condition, but the investigators and data analysts will remain blind to group assignment. This study will contain two parallel groups. Although participants will not initially be aware of the other study condition, they will not be blinded to study condition because those in the intervention condition will be viewing the altered ordering platform as they shop.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The researchers will recruit 500 regular food pantry clients to participate in a randomized-controlled trial that involves visiting the food pantry and selecting food using the web-based ordering system, having physical measurements collected by study staff, completing food frequency questionnaires, completing a health survey, and getting a blood draw to measure fruit and vegetable intake and health outcomes from biomarkers. Participants will be randomized to 1 of 2 conditions: 1) control group (usual care); or 2) behavioral economic intervention group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medical Ethics & Health Policy

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 8, 2019

Study Start

July 5, 2019

Primary Completion

December 21, 2022

Study Completion

December 21, 2022

Last Updated

February 29, 2024

Results First Posted

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations