Food PreferencesNCT04011384
A Trial of Behavioral Economic Interventions Among Food Pantry Clients
A study testing Behavioral economic intervention of online purchasing at a food pantry in people with Food Preferences, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Preferences
- What is being tested?
- Behavioral economic intervention of online purchasing at a food pantry
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2019to 21 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized Trial of Web-based Behavioral Economic Interventions to Promote Healthy Food Choices Among Food Pantry Clients
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).
Read the 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.
- Conditions
- Food Preferences
- Being tested
- Behavioral economic intervention of online purchasing at a food pantry
- Keywords
- Food Assistance, Economics, Behavioral, Food Labeling, Diet Records, Biomarkers
- Medical subject headings
- Food Preferences, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral economic intervention of online purchasing at a food pantryBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral economic intervention of online purchasing at a food pantry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Average monthly change from baseline across 3 months of participation, in number of calories from healthier foods per shopping trip.
Measured: 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
Average monthly change from baseline across 3 months of participation, in number of calories from less healthy foods per shopping trip.
Measured: 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
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.
Measured: Assessed at baseline and 3 months.
Biomarker Change in Fruit and Vegetable Intake
Change from baseline in carotenoid levels (scores range 0-800) as measured by the VeggieMeter®. The VeggieMeter® is a spectroscopy-based skin carotenoid measurement device, created by Longevity Link Corporation in 2015. It uses pressure-mediated reflection spectroscopy (RS) to detect and quantify skin carotenoids as a proxy for fruit and vegetable intake in humans. Validation studies show VeggieMeter scores to be highly correlated with blood serum measures of carotenoids (R=.81). Higher units represent a higher concentration of carotenoids in the skin.
Measured: Assessed at baseline and 3 months.
Change in Body Mass Index (BMI)
Change from baseline in BMI (weight in kg / height in meters^2)
Measured: Assessed at baseline and 3 months.
Change in Systolic Blood Pressure
Change from baseline in systolic blood pressure (indicator of heart health)
Measured: Assessed at baseline and 3 months.
Change in Diastolic Blood Pressure
Change from baseline in diastolic blood pressure (indicator of heart health)
Measured: Assessed at baseline and 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start5 Jul 2019
- Primary completion21 Dec 2022
- Study completion21 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Food PreferencesStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Connecticut, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Christina Roberto, Abramson Cancer Center at Penn Medicine
- Investigators
- Christina A Roberto, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011384
- Sponsor's protocol ID
- UPCC 06022
- Other IDs
- R01CA229502, 829702
- Status last verified
- Feb 2024
- First submitted
- 5 Jul 2019
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Web-based Behavioral Economic Interventions to Promote Healthy Food Choices Among Food Pantry Clients
- ClinicalTrials.gov ID
- NCT04011384
- Acronym / sponsor ID
- UPCC 06022
- Conditions
- Food Preferences
- Keywords
- Food Assistance, Economics, Behavioral, Food Labeling, Diet Records, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, University of Connecticut, National Cancer Institute (NCI)
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 21 Dec 2022 (actual)
- Study completion
- 21 Dec 2022 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 29 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Behavioral economic intervention of online purchasing at a food pantryParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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
Key exclusion criteria (6 listed)
- <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
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 |
|---|---|---|
| Behavioral economic intervention of online purchasing at a food pantryThis 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. | Behavioural | Behavioral Economic Intervention Group |
Primary outcome
Mean 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 3 months of participation.
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.
Mean 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 3 months of participation.
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.
7 secondary outcomes
Mean 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 3 months of participation.
Mean 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 3 months of participation.
Self-reported Change in Fruit and Vegetable Intake
Time frame: Assessed at baseline and 3 months.
Biomarker Change in Fruit and Vegetable Intake
Time frame: Assessed at baseline and 3 months.
Change in Body Mass Index (BMI)
Time frame: Assessed at baseline and 3 months.
Change in Systolic Blood Pressure
Time frame: Assessed at baseline and 3 months.
Change in Diastolic Blood Pressure
Time frame: Assessed at baseline and 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Christina A Roberto, PhD 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 Behavioral economic intervention of online purchasing at a food pantry in people with Food Preferences, run by Abramson Cancer Center at Penn Medicine 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 6 inclusion and 6 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 29 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean 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 3 months of participation.). 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 29 Feb 2024.