Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04011384
Other study ID # UPCC 06022
Secondary ID R01CA22950282970
Status Completed
Phase N/A
First received
Last updated
Start date July 5, 2019
Est. completion date December 21, 2022

Study information

Verified date February 2024
Source Abramson Cancer Center at Penn Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date December 21, 2022
Est. primary completion date December 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 - 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 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 - 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (4)

Lead Sponsor Collaborator
Abramson Cancer Center at Penn Medicine Massachusetts General Hospital, National Cancer Institute (NCI), University of Connecticut

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Collected from the online system at baseline and then each month for the remaining 3 months of participation.
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. Collected from the online system at baseline and then each month for the remaining 3 months of participation.
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. Collected from the online system at baseline and then each month for the remaining 3 months of participation.
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. Collected from the online system at baseline and then each month for the remaining 3 months of participation.
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. Assessed at baseline and 3 months.
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. Assessed at baseline and 3 months.
Secondary Change in Body Mass Index (BMI) Change from baseline in BMI (weight in kg / height in meters^2) Assessed at baseline and 3 months.
Secondary Change in Systolic Blood Pressure Change from baseline in systolic blood pressure (indicator of heart health) Assessed at baseline and 3 months.
Secondary Change in Diastolic Blood Pressure Change from baseline in diastolic blood pressure (indicator of heart health) Assessed at baseline and 3 months.
See also
  Status Clinical Trial Phase
Completed NCT03003923 - Promoting Vegetable Intake in Preschool Aged Children N/A
Completed NCT03113474 - Profiling the Endocannabinoid Response to Hedonic Eating N/A
Recruiting NCT04662606 - Neurofunctional Correlates of Intentional Actions Towards Food Stimuli N/A
Recruiting NCT06015490 - The Impact of the Physiological Response to Sugar on Brain Activity and Behavior N/A
Recruiting NCT05652842 - Assessing the Impact of Rotational and Shift Work on Sleep, Activity, Energy Balance, and Food Choice in Adults
Completed NCT05079477 - Online Study of the Effects of Sugary Drink Warning Labels on Consumption N/A
Recruiting NCT05977348 - Increasing Food Literacy in Preschoolers to Reduce Obesity Risk N/A
Completed NCT04544332 - The GAIN Study: Understanding What Helps Children Learn to Like and Eat New Foods
Completed NCT04497974 - Sweet Tooth: Nature or Nurture? Role of Long-term Dietary Sweetness Exposure on Sweetness Preferences N/A
Completed NCT03400566 - Effects of Experiential Learning on Vegetable Intake in Preschool Children N/A
Active, not recruiting NCT04262102 - The Dastatuz Project N/A
Completed NCT05592340 - Restaurant Menu Carbon Footprint Labeling N/A
Recruiting NCT02005003 - Cognitive and Metabolic Effects of a Probiotic Supplement N/A
Completed NCT05432271 - Online Food and Beverage Labels and Vending Machine Selections N/A
Active, not recruiting NCT04788836 - How Altered Gut-Brain-Axis Influences Food Choices: Part 2 (BrainFood)
Completed NCT05175391 - Improving Protein Intake in Older Adults N/A
Not yet recruiting NCT06324630 - Implementation of Innovative Food Prescription Programs in Older Adults N/A
Recruiting NCT02931812 - Feeding Behavior and Taste Sensitivity Before and After Liver or Renal Transplantation
Completed NCT02457234 - Influence of Cultural Immersion on Willingness to Try Fruits and Vegetables Among Children in Guam: the Traditions Study N/A
Recruiting NCT06432517 - Sources and Mechanisms of Energy Compensation N/A