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A Trial of Behavioral Economic Interventions Among Food Pantry Clients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011384
Recruitment Status : Active, not recruiting
First Posted : July 8, 2019
Last Update Posted : March 25, 2020
Sponsor:
Collaborators:
Massachusetts General Hospital
University of Connecticut
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Christina Roberto, University of Pennsylvania

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 1-year 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
Food Preferences Behavioral: Behavioral economic intervention of online purchasing at a food pantry Not Applicable

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 12 months of the study (participants typically shop monthly). Surveys and objective biomarkers will be collected at baseline, three-months, and twelve-months.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 1-year 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 (Participant)
Masking Description: Participants will be told the researchers are interested in food pantry ordering preferences, but participants will not know which condition has been assigned to individual participants.
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 : July 5, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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.




Primary Outcome Measures :
  1. 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 12 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 [ Time Frame: Collected from the online system at baseline and then each month for the remaining 12 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 [ Time Frame: Collected from the online system at baseline and then each month for the remaining 12 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 [ Time Frame: Collected from the online system at baseline and then each month for the remaining 12 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 [ Time Frame: Assessed at baseline, three months, and twelve 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 [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in beta carotene serum levels

  5. Change in Body Mass Index (BMI) [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in BMI (weight in kg / height in meters^2)

  6. Change in systolic blood pressure [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in systolic blood pressure (indicator of heart health)

  7. Change in diastolic blood pressure [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in diastolic blood pressure (indicator of heart health)

  8. Change in glycated hemoglobin (HbA1c) percentage [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in HbA1c percentage (screen for diabetes/pre-diabetes and monitors diabetics' glucose control -less than 5.7% is considered normal)

  9. Change in serum glucose levels [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in serum glucose levels (also monitors diabetics' glucose control)

  10. Change in C-reactive protein [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in C-reactive protein (high levels are an indicator of less healthy overall diet patterns)

  11. Change in High-density lipoproteins (HDL) [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in HDL (indicator of heart health)

  12. Change in Low-density lipoproteins (LDL) [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in LDL (indicator of heart health)

  13. Change in triglycerides [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in triglycerides (indicator of heart health)

  14. Change in Very-low-density lipoproteins (VLDL) [ Time Frame: Assessed at baseline, three months, and twelve months. ]
    Change from baseline in VLDL (indicator of heart health)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011384


Locations
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United States, Pennsylvania
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
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Principal Investigator: Christina A Roberto, PhD University of Pennsylvania
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Responsible Party: Christina Roberto, Assistant Professor of Medical Ethics & Health Policy, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04011384    
Other Study ID Numbers: 1R01CA229502 ( U.S. NIH Grant/Contract )
R01CA229502 ( U.S. NIH Grant/Contract )
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christina Roberto, University of Pennsylvania:
Food Assistance
Economics, Behavioral
Food Labeling
Diet Records
Biomarkers