ObesityNCT04235413
Fruits and Vegetables Incentives Study
A study testing Real-Time Incentives Group in people with Obesity and Fruit and Vegetable Intake, run by University of Pennsylvania at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Fruit and Vegetable Intake, Healthy Diet
- What is being tested?
- Real-Time Incentives Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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:
- 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
- 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
- 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
- To evaluate participant satisfaction with real-time healthy food choice incentives technology in both SNAP participants and income-eligible non-SNAP participants
- 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.
- Conditions
- Obesity, Fruit and Vegetable Intake, Healthy Diet
- Being tested
- Real-Time Incentives Group
- Keywords
- nutrition, health disparities, food purchases
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Incentives GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Incentives Group | Experimental | 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. Receives: Behavioral: Real-Time Incentives Group |
| Control Group | No intervention | No intervention administered. Each participant will be randomized using a blocking procedure (SNAP participant or not). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported fruits and vegetables (FV) purchase data
Participants will be asked if they increased, maintained, or decreased their purchases of canned, frozen, and fresh FV in the previous months.
Measured: up to 8 months
Intake of fruits and vegetables (FV) per day
FV consumption intake will be assessed using the Dietary Screener Questionnaire from NHANES (National Healthy and Examination Survey) 2009-2010.
Measured: Baseline, 6 months, 8 months
Secondary outcomes (4)
Total mean of fruits and vegetables expenditures/purchases and incentives earned
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.
Measured: up to 8 months
Dietary changes for each adult participant and one child in their household
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.
Measured: Baseline, 6 months, 8 months
Changes in dietary habits and food environments
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).
Measured: Baseline, 6 months, 8 months
Changes in BMI
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.
Measured: Baseline, 6 months, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start15 Jan 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Karen Glanz, PhD, MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235413
- Sponsor's protocol ID
- 833359
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2020
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Real-Time Incentives on Fruit and Vegetable Purchases and Diet
- ClinicalTrials.gov ID
- NCT04235413
- Acronym / sponsor ID
- 833359
- Conditions
- Obesity, Fruit and Vegetable Intake, Healthy Diet
- Keywords
- nutrition, health disparities, food purchases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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
- 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
- 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
- To evaluate participant satisfaction with real-time healthy food choice incentives technology in both SNAP participants and income-eligible non-SNAP participants
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real-Time Incentives Group | Experimental | Behavioral: Real-Time Incentives GroupEach 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. |
| Control Group | No intervention | –No intervention administered. Each participant will be randomized using a blocking procedure (SNAP participant or not). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-Time Incentives GroupThe 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. | Behavioural | Real-Time Incentives Group |
Primary outcome
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.
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.
4 secondary outcomes
Total mean of fruits and vegetables expenditures/purchases and incentives earned
Time frame: up to 8 months
Dietary changes for each adult participant and one child in their household
Time frame: Baseline, 6 months, 8 months
Changes in dietary habits and food environments
Time frame: Baseline, 6 months, 8 months
Changes in BMI
Time frame: Baseline, 6 months, 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Glanz, PhD, MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Incentives Group in people with Obesity and Fruit and Vegetable Intake, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported fruits and vegetables (FV) purchase data (time frame: up to 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.