Nutrition PoorNCT03952949
A Default Option to Enhance Dietary Quality in Participants With Food Insecurity
A study testing Default Option While Online Grocery Shopping and Nutrition Education in people with Nutrition Poor, run by University at Albany.
Trial summary
Food insecurity is associated with an increased risk of overweight/obesity and weight-related chronic illnesses. 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
- Nutrition Poor
- What is being tested?
- Default Option While Online Grocery Shopping and Nutrition Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2017to 28 Oct 2017
- 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
- 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
Who cannot join
- 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
About this study
Food insecurity is associated with an increased risk of overweight/obesity and weight-related chronic illnesses. 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 food selection in an online grocery shopping task.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.
Read the 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.
- Conditions
- Nutrition Poor
- Being tested
- Default Option While Online Grocery Shopping, Nutrition Education
- Keywords
- Nutrition, Food Insecurity, Choice Architecture, Nudge
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Default Option While Online Grocery ShoppingBehavioural
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 New York State Office of Temporary and Disability Assistance ("Eat Smart New York").
| Study group | Role | What they receive |
|---|---|---|
| Default | 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 While Online Grocery Shopping |
| Nutrition Education | Active comparator | Participants in the nutrition education condition were instructed to read a brief education brochure 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.
Nutritional Quality of Groceries Purchased
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 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 posted16 May 2019
- Study start4 Jan 2017
- Primary completion28 Oct 2017
- Study completion28 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia M. Hormes, PhD, Principal investigator, University at Albany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952949
- Sponsor's protocol ID
- 16-E-260-01
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Default Option to Enhance Dietary Quality in Participants With Food Insecurity
- ClinicalTrials.gov ID
- NCT03952949
- Acronym / sponsor ID
- 16-E-260-01
- Conditions
- Nutrition Poor
- Keywords
- Nutrition, Food Insecurity, Choice Architecture, Nudge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 28 Oct 2017 (actual)
- Study completion
- 28 Oct 2017 (actual)
- First posted
- 16 May 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 overweight/obesity and weight-related chronic illnesses. 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 food selection in an online grocery shopping task.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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Default | Experimental | Behavioral: Default Option While Online Grocery ShoppingParticipants 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 a brief education brochure 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 (6 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
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 Option While Online Grocery ShoppingThe "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 |
| Nutrition EducationThe nutrition education materials were adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance ("Eat Smart New York"). | Behavioural | Nutrition Education |
Primary outcome
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.
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 16 May 2019.
- Individual participant dataSharing planned: No
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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
Questions about this trial
What is this clinical trial studying?
A study testing Default Option While Online Grocery Shopping and Nutrition Education 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 6 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 16 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 of Groceries Purchased (time frame: Single visit, <1.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2019.