Nutrition PoorNCT03248583
Decision-Making Processes While Online Grocery Shopping
A study testing Default option, Psychoeducation and Incentive in people with Nutrition Poor, run by University at Albany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nutrition Poor
- What is being tested?
- Default option, Psychoeducation and Incentive
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2016to 29 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18 or older
- fluent in written and spoken English
- able to provide informed consent
Who cannot join
- 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)
About this study
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.
Read more
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.
- Conditions
- Nutrition Poor
- Being tested
- Default option, Psychoeducation, Incentive
- Keywords
- Proof-of-principle, Feasibility
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default optionOther
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.
PsychoeducationOther
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").
IncentiveOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Default | Experimental | Not described Receives: Other: Default option |
| Psychoeducation | Active comparator | Not described Receives: Other: Psychoeducation |
| Incentive | Active comparator | Not described Receives: Other: Incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single laboratory visit, <1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start13 Jan 2016
- Primary completion29 Sep 2016
- Study completion29 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nutrition PoorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Hormes, University at Albany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248583
- Sponsor's protocol ID
- 16-E-005-01
- Status last verified
- May 2019
- First submitted
- 28 Jul 2017
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29604181
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision-Making Processes While Online Grocery Shopping
- ClinicalTrials.gov ID
- NCT03248583
- Acronym / sponsor ID
- 16-E-005-01
- Conditions
- Nutrition Poor
- Keywords
- Proof-of-principle, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 29 Sep 2016 (actual)
- Study completion
- 29 Sep 2016 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Default | Experimental | Other: Default option |
| Psychoeducation | Active comparator | Other: Psychoeducation |
| Incentive | Active comparator | Other: Incentive |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18 or older
- fluent in written and spoken English
- able to provide informed consent
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Default optionThe "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. | Other | Default |
| PsychoeducationParticipants 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"). | Other | Psychoeducation |
| IncentiveParticipants 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. | Other | Incentive |
Primary outcome
Nutritional quality
Time frame: Single laboratory 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Derived from this study: PubMed 29604181Coffino 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Default option, Psychoeducation and Incentive in people with Nutrition Poor, run by University at Albany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutritional quality (time frame: Single laboratory visit, <1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03248583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.