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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA229502 | U.S. NIH Grant/Contract | View source | |
| 829702 | Other Identifier | IRB |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| University of Connecticut | OTHER |
| National Cancer Institute (NCI) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral economic intervention of online purchasing at a food pantry | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Collected from the online system at baseline and then each month for the remaining 3 months of participation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Collected from the online system at baseline and then each month for the remaining 3 months of participation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina A Roberto, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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Due to the Covid-19 pandemic, we lost 47 participants who were consented (before March 2020), but had not yet completed their baseline appointment. 3 others were accidentally enrolled, but did not meet our enrollment criteria and were excluded before baseline. Finally 1 was excluded because they were not randomized to a condition.
Participants were clients at a food pantry and were recruited either in-person at the pantry or by phone (after March 2020 due to the Covid-19 pandemic). Recruitment ran from July 2019 to September 2022. 70% of participants were recruited before the pandemic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Participants in this arm will view the typical web-based ordering system platform (usual care group). |
| FG001 | 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 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Participants in this arm will view the typical web-based ordering system platform (usual care group). |
| BG001 | 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 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic. | Posted | Mean | Standard Deviation | units of healthy food | Collected from the online system at baseline and then each month for the remaining 3 months of participation. |
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4 months, each participant was assessed from baseline through the 3 months of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Participants in this arm will view the typical web-based ordering system platform (usual care group). |
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Recruiting and assessing measurements (height, weight, blood pressure, and carotenoid levels) in person were limited by the onset of the Covid-19 pandemic in the middle of the study. In addition, monthly food pantry use was certainly impacted by the pandemic as well.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Laura Gibson | University of Pennsylvania | 215-898-7093 | gibla@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2022 | Dec 21, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2021 | Feb 1, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D005518 | Food Preferences |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
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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.
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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.
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| 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. |
| 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. | 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. | Assessed at baseline and 3 months. |
| Change in Body Mass Index (BMI) | Change from baseline in BMI (weight in kg / height in meters^2) | Assessed at baseline and 3 months. |
| Change in Systolic Blood Pressure | Change from baseline in systolic blood pressure (indicator of heart health) | Assessed at baseline and 3 months. |
| Change in Diastolic Blood Pressure | Change from baseline in diastolic blood pressure (indicator of heart health) | Assessed at baseline and 3 months. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Language | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Children at home | Count of Participants | Participants |
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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 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. |
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| Primary | 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. | Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic. | Posted | Mean | Standard Deviation | units of less healthy food | Collected from the online system at baseline and then each month for the remaining 3 months of participation. |
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| Secondary | 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. | Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic. | Posted | Mean | Standard Deviation | calories from healthy food | Collected from the online system at baseline and then each month for the remaining 3 months of participation. |
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| Secondary | 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. | Some participants were missing order data -- especially near March 2020 at the start of the Covid-19 pandemic. | Posted | Mean | Standard Deviation | calories from less healthy food | Collected from the online system at baseline and then each month for the remaining 3 months of participation. |
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| Secondary | 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. | Some participants were missing survey data -- especially near March 2020 at the start of the Covid-19 pandemic. | Posted | Mean | Standard Deviation | cup equivalents/day | Assessed at baseline and 3 months. |
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| Secondary | 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. | Many participants were unable to complete the 2nd in-person data collection due to Covid-19 | Posted | Mean | Standard Deviation | skin carotenoid score | Assessed at baseline and 3 months. |
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| Secondary | Change in Body Mass Index (BMI) | Change from baseline in BMI (weight in kg / height in meters^2) | Several participants were not able to do the follow-up in-person measures due to the Covid-19 pandemic | Posted | Mean | Standard Deviation | kilograms per square meter | Assessed at baseline and 3 months. |
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| Secondary | Change in Systolic Blood Pressure | Change from baseline in systolic blood pressure (indicator of heart health) | Several participants were not able to complete the follow-up in-person appointments due to the Covid-19 pandemic. | Posted | Mean | Standard Deviation | mmHg | Assessed at baseline and 3 months. |
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| Secondary | Change in Diastolic Blood Pressure | Change from baseline in diastolic blood pressure (indicator of heart health) | Several participants were not able to make it to their follow-up in-person appointment due to the Covid-19 pandemic. | Posted | Mean | Standard Deviation | mmHg | Assessed at baseline and 3 months. |
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| 0 |
| 109 |
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| 109 |
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| 109 |
| EG001 | 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 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. | 0 | 124 | 0 | 124 | 0 | 124 |
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