NCT03248583

Brief Summary

Individuals living with food insecurity are disproportionately affected by overweight and obesity and associated chronic health problems. There remains a lack of sustainable and scalable interventions targeting widespread barriers to access to healthy foods in this population to increase the nutritional quality of foods purchased for preparation and consumption at home. This randomized controlled proof-of-principle trial was designed to examine the feasibility and initial efficacy of a "default option" in enhancing the nutritional quality of groceries selected via the online shopping service of a local grocery store under conditions that mimic the financial constraints typical of individuals living with food insecurity. In behavioral economics, the "default option" refers to the option a consumer selects if no active choice is made. The notion of the default option is based on the concept of "asymmetrical" or "libertarian paternalism," which seeks to subtly shift consumer behavior in a manner that promotes welfare, but without overtly interfering with the individual's freedom to choose. It was hypothesized that the "default" option effectively increases the nutritional quality of foods purchased online, compared to monetary incentives and psychoeducation about nutrition. Female undergraduate students (n = 60) selected food for one week using the online shopping service of a local grocery store with a budget corresponding to maximum weekly Supplemental Nutrition Assistance Program (SNAP) benefits. Before completing the task again, participants were randomized to: (1) a small monetary "incentive" for selecting groceries that meet nutritional guidelines (n = 17), (2) an "educational" brochure (n = 24), or (3) a "default" pre-filled online shopping cart containing a nutritionally balanced selection of groceries to which they could freely make changes (n = 18). Primary outcome measures capture the nutritional quality of groceries selected/ purchased.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

9 months

First QC Date

July 28, 2017

Last Update Submit

May 9, 2019

Conditions

Keywords

Proof-of-principleFeasibility

Outcome Measures

Primary Outcomes (1)

  • Nutritional quality

    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 laboratory visit, <1.5 hours

Study Arms (3)

Default

EXPERIMENTAL
Other: Default option

Psychoeducation

ACTIVE COMPARATOR
Other: Psychoeducation

Incentive

ACTIVE COMPARATOR
Other: Incentive

Interventions

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 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.

Default

Participants in the psychoeducation condition were instructed to read a brief psychoeducational brochure adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance ("Eat Smart New York").

Psychoeducation

Participants in the incentive condition were informed that they will receive a gift card to a major retailer of their choice if they select groceries that meet recommended nutritional guidelines for macro- and micronutrient requirements. Participants were given examples of macro- and micronutrients to ensure that the instructions were clear.

Incentive

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParticipant eligibility was based in part on self-representation of gender identity as female.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older
  • fluent in written and spoken English
  • able to provide informed consent

You may not qualify if:

  • significant dietary restrictions (i.e., meat avoidance, food allergies, religious dietary restrictions, etc.)
  • likely presence of current eating disorder diagnosis (score \>/= 2 on SCOFF screening measure)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Coffino JA, Hormes JM. A Default Option to Enhance Nutrition Within Financial Constraints: A Randomized, Controlled Proof-of-Principle Trial. Obesity (Silver Spring). 2018 Jun;26(6):961-967. doi: 10.1002/oby.22151. Epub 2018 Mar 31.

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 14, 2017

Study Start

January 13, 2016

Primary Completion

September 29, 2016

Study Completion

September 29, 2016

Last Updated

May 13, 2019

Record last verified: 2019-05