Fruits and Vegetables Incentives Study

January 10, 2023 updated by: University of Pennsylvania

Impact of Real-Time Incentives on Fruit and Vegetable Purchases and Diet

The goal of this study is to evaluate the effectiveness of financial incentives delivered in real-time at point of purchase, on low-income consumers' purchase of fruits and vegetables, fruits and vegetables consumption, diet quality, and weight/BMI. The study will test real-time incentives compared to a no-incentive control condition.

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

To address diet quality disparities in low-income families, policy makers and health experts recommend strategies such as financial incentives to promote consumption of fruits and vegetables. Real-time incentives for purchasing fruits and vegetables are promising strategies to improve families' diets and health.

The aims of the study are:

  1. To test the effects of financial incentives, delivered in real-time at the point of purchase, on low-income consumer purchases of fruits and vegetables
  2. To evaluate the impact of real-time financial incentives compared to a control condition on FV consumption among adults and their children ,shopping habits, home food environments, diet quality, and weight/BMI
  3. To adapt mobile platform technology to provide regular feedback to participants to motivate use of the incentive program to increase purchases and consumption of fruits and vegetables
  4. To evaluate participant satisfaction with real-time healthy food choice incentives technology in both SNAP participants and income-eligible non-SNAP participants
  5. To assess the acceptability and ease of use of real-time healthy food choice incentives technology among retails supermarket managers and staff in low-income neighborhoods.

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.
244

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 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Speak English
  • Do most of their food shopping at a participating supermarket
  • Receive or are eligible to receive SNAP benefits
  • Have a child in the household between the ages of 2-17
  • Have a working smartphone
  • Be the main household shopper

Exclusion Criteria:

  • Participants will be excluded if the primary shopper and/or any children in the family have major medical or dental conditions that would prevent them from eating fruits and vegetables, or if they have a serious neurological disorder, dementia, or psychiatric condition that interferes with understanding study procedures

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: Real-Time Incentives Group
Each participant will be randomized using a blocking procedure (SNAP participant or not). The intervention will last 6 months and consist of receiving real-time financial incentives at the point of purchase for eligible fruits and vegetables purchases.
Behavioral: Real-Time Incentives Group
The use of a novel computer program with a mobile phone interface to provide real-time financial incentives at the point of purchase for discounts on fruit and vegetables in low-income families. This intervention will be applied to subjects randomized to the intervention arm. They will receive 50% off eligible fruits and vegetable products at the point of purchase, up to $10 a week for 6 months. Maximum amount they can receive is $260 in discounts over the 6 month period.
No Intervention: Control Group
No intervention administered. Each participant will be randomized using a blocking procedure (SNAP participant or not).

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
Self-reported fruits and vegetables (FV) purchase data
Time Frame: up to 8 months
Participants will be asked if they increased, maintained, or decreased their purchases of canned, frozen, and fresh FV in the previous months.
up to 8 months
Intake of fruits and vegetables (FV) per day
Time Frame: Baseline, 6 months, 8 months
FV consumption intake will be assessed using the Dietary Screener Questionnaire from NHANES (National Healthy and Examination Survey) 2009-2010.
Baseline, 6 months, 8 months

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
Total mean of fruits and vegetables expenditures/purchases and incentives earned
Time Frame: up to 8 months
Solutran analytics, our partner that will be delivering the incentives, will be providing weekly data on FV expenditures/purchases and incentives earned (in dollars). The total mean of FV expenditures/purchases and incentives earned will be computed.
up to 8 months
Dietary changes for each adult participant and one child in their household
Time Frame: Baseline, 6 months, 8 months
High sugar/fat food and sugary beverage intake will be assessed using the Dietary Screener Questionnaire from NHANES (National Healthy and Examination Survey) 2009-2010.
Baseline, 6 months, 8 months
Changes in dietary habits and food environments
Time Frame: Baseline, 6 months, 8 months
Surveys will ask about perceived availability, cost and quality of FV at stores, the home food environment (both healthy and unhealthy foods), shopping habits and where they shop, FV practices for children in the home, and FV preparation and consumption patterns. Part of the survey is a modified version of the NEMS-P (Nutrition Environment Measures Survey- Perceived).
Baseline, 6 months, 8 months
Changes in BMI
Time Frame: Baseline, 6 months, 8 months
Self-reported weight and height (inches) will be collected at each time point via self-report. Using weight and height values collected, BMI, BMI categories, and BMI z-scores (for children) will be computed for each time point.
Baseline, 6 months, 8 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.
University of Pennsylvania

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.
Robert Wood Johnson Foundation

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: Karen Glanz, PhD, MPH, 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.
January 15, 2020

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.
November 30, 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.
November 30, 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).
January 8, 2020

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.
January 16, 2020

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.
January 21, 2020

Study Record Updates

Last Update Posted (Actual)

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.
January 12, 2023

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.
January 10, 2023

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.
January 1, 2023

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.
  • 833359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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