- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952949
A Default Option to Enhance Dietary Quality in Participants With Food Insecurity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Food insecurity is associated with an increased risk of overweight/obesity and weight-related chronic illnesses. The present study provides preliminary evidence for the efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity.
In behavioral economics, the default option refers to the option a consumer selects if no active choice is made. This study aims to determine whether the use of a default prefilled online grocery shopping cart results in the purchase of healthier food items in individuals with food insecurity, compared to nutrition education. The default approach, a non-monetary intervention that manipulates choice architecture, improves food choice behaviors in individuals facing significant financial constraints. The intervention is potentially broadly scalable via online platforms.
It was hypothesized that the default option effectively increases the nutritional quality of foods purchased online, compared to nutrition education.
Fifty participants recruited from food pantries in New York in 2018 were randomized to: (1) review nutrition information before selecting groceries for a week using a local grocery store's online shopping and delivery service (n = 23) or (2) modify a default prefilled online shopping cart containing groceries that meet nutritional guidelines according to their personal preferences (n = 27).
Primary outcome measures capture the nutritional quality of groceries purchased. Our primary nutritional outcomes include servings of whole grains fruits and vegetables, fiber, daily calories, fat, saturated fat, sodium and cholesterol content.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18 or older
- single person household
- fluent in written and spoken English
- able to provide informed consent
- food-insecure (verbal agreement that they consider themselves to be of that category) but not currently receiving SNAP benefits (as they would otherwise have access to twice the amount of benefits typically allocated; please note that all participants will be provided with information about enrollment in SNAP following study participation)
- current residence in a zip code served by Price Chopper's delivery program
Exclusion Criteria:
- None of the following dietary restrictions: vegetarian/vegan, gluten-free/celiacs disease, and lactose intolerant
- current residence outside of a zip code served by Price Chopper's delivery program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Default
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.
|
Active Comparator: Nutrition Education
Participants in the nutrition education condition were instructed to read a brief education brochure before online grocery shopping.
|
The nutrition education materials were adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance ("Eat Smart New York").
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nutritional Quality of Groceries Purchased
Time Frame: Single visit, <1.5 hours
|
The Thrifty Food Plan Calculator (TFPC) was used to quantify the nutritional quality of groceries selected by study participants.
The TFPC was developed using U.S. Department of Agriculture nutrition and consumption data and is designed to have users input information about the relative amount of money spent on various categories of food and provides comprehensive information on caloric, macro-, and micronutrient content of the foods selected based on participant age and gender.
|
Single visit, <1.5 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia M. Hormes, PhD, University at Albany
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-E-260-01
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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