Food SelectionNCT04186533
A Default Option for Health: Improving Nutrition Within the Financial and Geographic Constraints of Food Insecurity
A study testing Default Option and Nutrition Education in people with Food Selection and Obesity, run by University at Albany at 1 site in United States.
Trial summary
Food insecurity is associated with an increased risk of obesity. The availability of a default option (i.e., option a consumer selects if no active choice is made) has been shown to effectively nudge consumer behavior. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Selection, Obesity
- What is being tested?
- Default Option and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 6 Jun 2018
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Food insecurity is associated with an increased risk of obesity. The availability of a default option (i.e., option a consumer selects if no active choice is made) has been shown to effectively nudge consumer behavior. An online default option (i.e., prefilled grocery shopping cart) was previously shown to positively impact the food purchases of individuals with food insecurity.The present study aims to extend these findings bye examining efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity over the course of a month.
Read the 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).
- Conditions
- Food Selection, Obesity
- Being tested
- Default Option, Nutrition Education
- Keywords
- food insecurity, nutrition, obesity, default option, online grocery shopping
- Medical subject headings
- Food Preferences, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default OptionBehavioural
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.
Nutrition EducationBehavioural
The nutrition education materials were adapted from materials currently utilized by the Supplemental Nutrition Assistance Education Program
| Study group | Role | What they receive |
|---|---|---|
| Default Intervention | Experimental | 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. Receives: Behavioral: Default Option |
| Nutrition Education | Active comparator | Participants in the nutrition education condition were instructed to read brief nutrition education handouts before online grocery shopping. Receives: Behavioral: Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy Eating Index Score
(score ranging from 0-100
Measured: 1 month
Calories
kcal
Measured: 1 month
Energy Density
kcal/grams
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start9 Feb 2018
- Primary completion29 May 2018
- Study completion6 Jun 2018
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 Food SelectionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Principal investigator, Julia Hormes, University at Albany
- Investigators
- Julia M Hormes, PhD, Principal investigator, University at Albany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04186533
- Sponsor's protocol ID
- 17-E-224-01
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coffino JA, Han GT, Evans EW, Luba R, Hormes JM. A Default Option to Improve Nutrition for Adults With Low Income Using a Prefilled Online Grocery Shopping Cart. J Nutr Educ Behav. 2021 Sep;53(9):759-769. doi: 10.1016/j.jneb.2021.06.011.
PubMed 34509276
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Default Option for Health: Improving Nutrition Within the Financial and Geographic Constraints of Food Insecurity
- ClinicalTrials.gov ID
- NCT04186533
- Acronym / sponsor ID
- 17-E-224-01
- Conditions
- Food Selection, Obesity
- Keywords
- food insecurity, nutrition, obesity, default option, online grocery shopping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 29 May 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 4 Dec 2019 (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.
Food insecurity is associated with an increased risk of obesity. The availability of a default option (i.e., option a consumer selects if no active choice is made) has been shown to effectively nudge consumer behavior. An online default option (i.e., prefilled grocery shopping cart) was previously shown to positively impact the food purchases of individuals with food insecurity.The present study aims to extend these findings bye examining efficacy of an online default option in enhancing the nutritional quality of online grocery purchases in individuals with food insecurity over the course of a month.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Default Intervention | Experimental | Behavioral: Default OptionParticipants 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. |
| Nutrition Education | Active comparator | Behavioral: Nutrition EducationParticipants in the nutrition education condition were instructed to read brief nutrition education handouts before online grocery shopping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
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 prefilled online shopping cart containing groceries that met nutritional requirements based on participants' gender and age. | Behavioural | Default Intervention |
| Nutrition EducationThe nutrition education materials were adapted from materials currently utilized by the Supplemental Nutrition Assistance Education Program | Behavioural | Nutrition Education |
Primary outcome
Healthy Eating Index Score
Time frame: 1 month
(score ranging from 0-100
Calories
Time frame: 1 month
kcal
Energy Density
Time frame: 1 month
kcal/grams
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 4 Dec 2019.
- Derived from this study: PubMed 34509276Coffino JA, Han GT, Evans EW, Luba R, Hormes JM. A Default Option to Improve Nutrition for Adults With Low Income Using a Prefilled Online Grocery Shopping Cart. J Nutr Educ Behav. 2021 Sep;53(9):759-769. doi: 10.1016/j.jneb.2021.06.011.
- Individual participant dataSharing planned: No
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Influence of Social Media Ads on Food Choice - Master Protocol
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Optimization Trial to Empower sElection of Nutritious Foods
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Food Menu Labelling Effects on Individuals With Eating Disorders and Other Mental Health Conditions.
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RecruitingObservational study
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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.
Julia M Hormes, PhD principal investigator
University at Albany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Default Option and Nutrition Education in people with Food Selection and Obesity, run by University at Albany at 1 site in United States.
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 7 inclusion and 0 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Healthy Eating Index Score (time frame: 1 month). The study lists 3 primary outcomes in all. 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 NCT04186533, 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 4 Dec 2019.