- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04186533
A Default Option for Health: Improving Nutrition Within the Financial and Geographic Constraints of Food Insecurity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Food insecurity is associated with an increased risk of obesity and weight-related illnesses. The present study is the first longitudinal randomized control trial to examine if an online prefilled grocery shopping cart (i.e., a default cart) nudges individuals with food insecurity to purchase healthier groceries compared to receiving nutrition education.
It was hypothesized that the prefilled online grocery shopping cart (i.e., default condition) will result in a significant improvement in the nutritional quality of groceries purchased compared to those receiving nutrition education.
Thirty-eight food pantry users recruited from food pantries in New York in 2018 were enrolled in the present study and were given $48.50 to purchase groceries weekly using an online grocery website for five weeks. At baseline, participants were instructed to purchase groceries keeping in mind nutrition, cost, and taste. For the subsequent four weeks (T1-T4), participants were randomized to receive 1) nutrition education or 2) a prefilled online grocery shopping cart that met their nutritional needs based on age and sex (Default).
Our primary nutritional outcomes included HEI scores, calories (kcal), and energy density (kcal/grams).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Albany, New York, United States, 12222
- University at Albany, SUNY
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 18 years old
- Residing in a single person household
- Receiving assistance at a food pantry
- Able to read and write in English
- Able to provide informed consent
- Current residence in a zip code served by Price Chopper's delivery program
- None of the following dietary restrictions: Vegetarian/vegan, Gluten-free/celiacs, Lactose intolerance, egg allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Default Intervention
Participants in the default condition were presented with a pre-filled online shopping cart containing a combination of groceries that meet macro- and micronutrient requirements for their gender and age, and told that they are free to delete, add, and exchange any item they wish to finalize their selections.
|
The default option is a behavioral economics construct that refers to the option a consumer selects if no active choice is made (e.g.
opt-out 401K plans, which significantly increase enrollment, compared to active sign up).
Participants in the default condition were presented with a prefilled online shopping cart containing groceries that met nutritional requirements based on participants' gender and age.
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Active Comparator: Nutrition Education
Participants in the nutrition education condition were instructed to read brief nutrition education handouts before online grocery shopping.
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The nutrition education materials were adapted from materials currently utilized by the Supplemental Nutrition Assistance Education Program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Healthy Eating Index Score
Time Frame: 1 month
|
(score ranging from 0-100
|
1 month
|
Calories
Time Frame: 1 month
|
kcal
|
1 month
|
Energy Density
Time Frame: 1 month
|
kcal/grams
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia M Hormes, PhD, University at Albany
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-E-224-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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