A Trial of Behavioral Economic Interventions Among Food Pantry Clients

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04011384
Collaborator
Massachusetts General Hospital (Other), University of Connecticut (Other), National Cancer Institute (NCI) (NIH)
500
1
2
41.9
11.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral economic intervention of online purchasing at a food pantry
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Single (Investigator)
Masking Description:
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.
Primary Purpose:
Prevention
Official Title:
A Randomized Trial of Web-based Behavioral Economic Interventions to Promote Healthy Food Choices Among Food Pantry Clients
Actual Study Start Date :
Jul 5, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Monthly change in number of units of healthier foods [Collected from the online system at baseline and then each month for the remaining 3 months of participation.]

    Monthly change from baseline 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.

  2. Monthly change in number of units of less healthy foods [Collected from the online system at baseline and then each month for the remaining 3 months of participation.]

    Monthly change from baseline 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.

Secondary Outcome Measures

  1. 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.]

    Monthly change from baseline in number of calories from healthier foods per shopping trip.

  2. 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.]

    Monthly change from baseline in number of calories from less healthy foods per shopping trip.

  3. Self-reported change in fruit and vegetable intake [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.

  4. Biomarker change in fruit and vegetable intake [Assessed at baseline and 3 months.]

    Change from baseline in carotenoid levels

  5. Change in Body Mass Index (BMI) [Assessed at baseline and 3 months.]

    Change from baseline in BMI (weight in kg / height in meters^2)

  6. Change in systolic blood pressure [Assessed at baseline and 3 months.]

    Change from baseline in systolic blood pressure (indicator of heart health)

  7. Change in diastolic blood pressure [Assessed at baseline and 3 months.]

    Change from baseline in diastolic blood pressure (indicator of heart health)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Massachusetts General Hospital
  • University of Connecticut
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Christina A Roberto, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christina Roberto, PHD, Assistant Professor of Medical Ethics & Health Policy, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04011384
Other Study ID Numbers:
  • 1R01CA229502
  • R01CA229502
First Posted:
Jul 8, 2019
Last Update Posted:
Sep 16, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Christina Roberto, PHD, Assistant Professor of Medical Ethics & Health Policy, University of Pennsylvania

Study Results

No Results Posted as of Sep 16, 2021