Cardiovascular DiseaseNCT02808910
A Small Nudge for Better Health Through Reduced Salt Intake, Increased Vegetable Intake, and Smaller Portion Size
A study testing Nudged to eat less added salt and more other seasonings, Nudged to avoid foods high in salt content, and to choose foods low in salt content and Nudged to eat more vegetables in people with Cardiovascular Disease and Obesity, run by LHL Helse at 1 site in Norway.
Trial summary
This study will investigate whether small changes (nudges) made in a cafeteria, where participants eat for 4 weeks, can improve their food behavior and health during the 4 weeks, and 6 weeks and 6 months after their stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Obesity
- What is being tested?
- Nudged to eat less added salt and more other seasonings, Nudged to avoid foods high in salt content, and to choose foods low in salt content and Nudged to eat more vegetables
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2016to 1 Apr 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants should be part of the 4 week rehabilitation course at the Feiring heart clinic
- Participants should be willing and able to complete the necessary registration of food choices, and the relevant questionnaires
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nudging: How Small Changes in the Cafeteria of the Feiring Heart Clinic Can Result in a Healthier Food Choice.
This study will investigate whether small changes (nudges) made in a cafeteria, where participants eat for 4 weeks, can improve their food behavior and health during the 4 weeks, and 6 weeks and 6 months after their stay. Half the participants will be exposed to one of four types of nudges (focused on reducing salt intake, increasing vegetable intake, reducing portion size, and a combination of these nudges), and half of the participants will eat in the cafeteria as it is currently, without modifications.
Read the detailed description
A healthy diet is an important pillar for public health and for the prevention of several lifestyle diseases (e.g. obesity, cardiovascular diseases). However, diet choices are often not conscious choices. While it may help to make individuals more aware of healthy options for example through education or nutrition labels, it remains difficult for many to eat healthy. The food environment in which choices are made has an impact on the choice. Smart design of the food environment may help individuals to make a healthier choice, by nudging them towards the healthier alternative, while not limiting the availability of the less healthy choice.
This study tests how these 'nudges' can affect food behavior and health of participants in a 4-week rehabilitation course at Feiring Heart clinic. Nudges will be implemented in the cafeteria at the clinic.
Three types of nudges will be tested:
- Salt nudge: aims to reduce salt (sodium) intake. Salt will be less easily available in the cafeteria, and other spices (without sodium) will be made easily available. Food in the buffet that is either very high or very low in salt will be labeled.
- Vegetable nudge: aims to increase vegetable intake. Names of the vegetable dishes in the buffet will be made more attractive, signs will be placed with reminders to eat more vegetables, and with visual indications of the percentage of vegetables that should be part of a meal.
- Portion size nudge: aims to decrease portion size. Smaller plates will be provided, and utensils for self-serving calorie-dense foods in the buffet will be smaller than normal.
- One period will also combine all the nudges described above.
Outcomes include measures of food intake during the 4-week rehabilitation course, and whether food habits 6 weeks and 6 months after the 4-week course have changed, compared to before the course. BMI will be monitored during the 4-week period and self-assessed in the 6 months after. Physical activity habits will be considered during the entire experimental period, and satisfaction with the cafeteria food and service will be monitored throughout to assess whether the nudges impact customer satisfaction.
Results are expected to be transferable to other heart clinics, and cafeterias in other institutions.
- Conditions
- Cardiovascular Disease, Obesity
- Being tested
- Nudged to eat less added salt and more other seasonings, Nudged to avoid foods high in salt content, and to choose foods low in salt content, Nudged to eat more vegetables, Nudged to eat smaller portions, Nudged to eat less calorie-dense food
- Keywords
- behavior, food intake, salt, vegetables, portion size, weight loss, habits
- Medical subject headings
- Cardiovascular Diseases, Obesity, Behavior, Weight Loss, Habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nudged to eat less added salt and more other seasoningsBehavioural
Nudged to avoid foods high in salt content, and to choose foods low in salt contentBehavioural
Nudged to eat more vegetablesBehavioural
Nudged to eat smaller portionsBehavioural
Nudged to eat less calorie-dense foodBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Salt nudge | Experimental | The following changes will be made in the cafeteria: Salt will be placed in a corner of the buffet, rather than on each dining table. Other spices, without sodium, will be provided on the table. A sign will be placed on the table that nudges participants to try the other spices. Food in the buffet that is high in salt will be labeled with a negative-appearing symbol, and food in the buffet that is low in salt will be labeled with a positive symbol. Receives: Behavioral: Nudged to eat less added salt and more other seasonings; Behavioral: Nudged to avoid foods high in salt content, and to choose foods low in salt content |
| Vegetable nudge | Experimental | The following changes will be made in the cafeteria: Names of the vegetable dishes in the buffet will be made more attractive. Signs will be placed with reminders to eat more vegetables. Signs will be placed with a visual indication of the percentage of a meal that should consist of vegetables. Receives: Behavioral: Nudged to eat more vegetables |
| Portion size nudge | Experimental | The following changes will be made in the cafeteria: Smaller plates will replace the regular plates. Verbal and visual nudges to reduce portion size will be given. Utensils for self-serving calorie-dense foods in the buffet will be smaller than normal. Receives: Behavioral: Nudged to eat smaller portions; Behavioral: Nudged to eat less calorie-dense food |
| Combined nudge | Experimental | All three nudges are combined in this intervention. Receives: Behavioral: Nudged to eat less added salt and more other seasonings; Behavioral: Nudged to avoid foods high in salt content, and to choose foods low in salt content; Behavioral: Nudged to eat more vegetables; Behavioral: Nudged to eat smaller portions; Behavioral: Nudged to eat less calorie-dense food |
| Control groups | No intervention | No changes are made to the cafeteria, compared to the pre-study situation. One control group participates after each of the nudges to control for effects of time of the year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMI from start of intervention to end of intervention
BMI is measured, and change in BMI between day 0 and day 28 is used.
Measured: Measured at baseline at day 0 of intervention and at completion of intervention at day 28 of intervention)
Change in dietary habits 1
Habits are compared with habits as listed before the start of the 4 week intervention period. Done through an online survey.
Measured: 6 weeks after the 4 week intervention period
Change in dietary habits 2
Habits are compared with habits as listed before the start of the 4 week intervention period. Done through an online survey.
Measured: 6 months after the 4 week intervention period
Secondary outcomes (8)
Dietary choices in cafeteria 1.1
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Tuesday lunch meal during the first week of the intervention
Dietary choices in cafeteria 1.2
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Thursday lunch meal during the first week of the intervention
Dietary choices in cafeteria 2.1
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Tuesday lunch meal during the second week of the intervention
Dietary choices in cafeteria 2.2
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Thursday lunch meal during the second week of the intervention
Dietary choices in cafeteria 3.1
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Tuesday lunch meal during the third week of the intervention
Dietary choices in cafeteria 3.2
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Thursday lunch meal during the third week of the intervention
Dietary choices in cafeteria 4.1
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Tuesday lunch meal during the fourth week of the intervention
Dietary choices in cafeteria 4.2
Participants make photos of their meal including drinks, and register any condiments or seasoning added
Measured: Thursday lunch meal during the fourth week of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startApr 2016
- Primary completion20 May 2017
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- LHL Helse
- Sponsor type
- University, hospital or other
- Collaborators
- NIBIO - Norwegian Institute of Bioeconomy Research, Norwegian University of Life Sciences, Animalia
- Responsible party
- Sponsor
- Investigators
- Laila Dufseth, Principal investigator, LHL Helse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808910
- Sponsor's protocol ID
- 2016/231300
- Other IDs
- 2016
- Status last verified
- Aug 2019
- First submitted
- 3 May 2016
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wansink, B. & Sobal, J. Mindless eating: The 200 daily food decisions we overlook. Environment and Behavior. 2007, 39(1):106-123. 2007
Rolls BJ. Plenary Lecture 1: Dietary strategies for the prevention and treatment of obesity. Proc Nutr Soc. 2010 Feb;69(1):70-9. doi: 10.1017/S0029665109991674. Epub 2009 Dec 3.
PubMed 19954563Rozin, P., Scott, S., Dingley, M., Urbanek, J.K., Jiang, H., Kaltenbach, M. Nudge to nobesity I: Minor changes in accessibility decrease food intake. Judgment and Decision Making, 2011, 6:323-332.
Just, D.R. & Wansink, B. Smarter Lunchrooms: Using Behavioral Economics to Improve Meal Selection. Chocies Magazine. 2009, 24(3).
van Kleef E, Otten K, van Trijp HC. Healthy snacks at the checkout counter: a lab and field study on the impact of shelf arrangement and assortment structure on consumer choices. BMC Public Health. 2012 Dec 12;12:1072. doi: 10.1186/1471-2458-12-1072.
PubMed 23231863
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nudging: How Small Changes in the Cafeteria of the Feiring Heart Clinic Can Result in a Healthier Food Choice.
- ClinicalTrials.gov ID
- NCT02808910
- Acronym / sponsor ID
- 2016/231300
- Conditions
- Cardiovascular Disease, Obesity
- Keywords
- behavior, food intake, salt, vegetables, portion size, weight loss, habits
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- LHL HelseUniversity, hospital or other
- Collaborators
- NIBIO - Norwegian Institute of Bioeconomy Research, Norwegian University of Life Sciences, Animalia
- Study start
- Apr 2016
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
This study will investigate whether small changes (nudges) made in a cafeteria, where participants eat for 4 weeks, can improve their food behavior and health during the 4 weeks, and 6 weeks and 6 months after their stay. Half the participants will be exposed to one of four types of nudges (focused on reducing salt intake, increasing vegetable intake, reducing portion size, and a combination of these nudges), and half of the participants will eat in the cafeteria as it is currently, without modifications.
Detailed description
A healthy diet is an important pillar for public health and for the prevention of several lifestyle diseases (e.g. obesity, cardiovascular diseases). However, diet choices are often not conscious choices. While it may help to make individuals more aware of healthy options for example through education or nutrition labels, it remains difficult for many to eat healthy. The food environment in which choices are made has an impact on the choice. Smart design of the food environment may help individuals to make a healthier choice, by nudging them towards the healthier alternative, while not limiting the availability of the less healthy choice.
This study tests how these 'nudges' can affect food behavior and health of participants in a 4-week rehabilitation course at Feiring Heart clinic. Nudges will be implemented in the cafeteria at the clinic.
Three types of nudges will be tested:
- Salt nudge: aims to reduce salt (sodium) intake. Salt will be less easily available in the cafeteria, and other spices (without sodium) will be made easily available. Food in the buffet that is either very high or very low in salt will be labeled.
- Vegetable nudge: aims to increase vegetable intake. Names of the vegetable dishes in the buffet will be made more attractive, signs will be placed with reminders to eat more vegetables, and with visual indications of the percentage of vegetables that should be part of a meal.
- Portion size nudge: aims to decrease portion size. Smaller plates will be provided, and utensils for self-serving calorie-dense foods in the buffet will be smaller than normal.
- One period will also combine all the nudges described above.
Outcomes include measures of food intake during the 4-week rehabilitation course, and whether food habits 6 weeks and 6 months after the 4-week course have changed, compared to before the course. BMI will be monitored during the 4-week period and self-assessed in the 6 months after. Physical activity habits will be considered during the entire experimental period, and satisfaction with the cafeteria food and service will be monitored throughout to assess whether the nudges impact customer satisfaction.
Results are expected to be transferable to other heart clinics, and cafeterias in other institutions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Salt nudge | Experimental | Behavioral: Nudged to eat less added salt and more other seasonings, Behavioral: Nudged to avoid foods high in salt content, and to choose foods low in salt contentThe following changes will be made in the cafeteria: Salt will be placed in a corner of the buffet, rather than on each dining table. Other spices, without sodium, will be provided on the table. A sign will be placed on the table that nudges participants to try the other spices. Food in the buffet that is high in salt will be labeled with a negative-appearing symbol, and food in the buffet that is low in salt will be labeled with a positive symbol. |
| Vegetable nudge | Experimental | Behavioral: Nudged to eat more vegetablesThe following changes will be made in the cafeteria: Names of the vegetable dishes in the buffet will be made more attractive. Signs will be placed with reminders to eat more vegetables. Signs will be placed with a visual indication of the percentage of a meal that should consist of vegetables. |
| Portion size nudge | Experimental | Behavioral: Nudged to eat smaller portions, Behavioral: Nudged to eat less calorie-dense foodThe following changes will be made in the cafeteria: Smaller plates will replace the regular plates. Verbal and visual nudges to reduce portion size will be given. Utensils for self-serving calorie-dense foods in the buffet will be smaller than normal. |
| Combined nudge | Experimental | Behavioral: Nudged to eat less added salt and more other seasonings, Behavioral: Nudged to avoid foods high in salt content, and to choose foods low in salt content, Behavioral: Nudged to eat more vegetables, Behavioral: Nudged to eat smaller portions, Behavioral: Nudged to eat less calorie-dense foodAll three nudges are combined in this intervention. |
| Control groups | No intervention | –No changes are made to the cafeteria, compared to the pre-study situation. One control group participates after each of the nudges to control for effects of time of the year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants should be part of the 4 week rehabilitation course at the Feiring heart clinic
- Participants should be willing and able to complete the necessary registration of food choices, and the relevant questionnaires
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Nudged to eat less added salt and more other seasonings | Behavioural | Combined nudge, Salt nudge |
| Nudged to avoid foods high in salt content, and to choose foods low in salt content | Behavioural | Combined nudge, Salt nudge |
| Nudged to eat more vegetables | Behavioural | Combined nudge, Vegetable nudge |
| Nudged to eat smaller portions | Behavioural | Combined nudge, Portion size nudge |
| Nudged to eat less calorie-dense food | Behavioural | Combined nudge, Portion size nudge |
Primary outcome
Change in BMI from start of intervention to end of intervention
Time frame: Measured at baseline at day 0 of intervention and at completion of intervention at day 28 of intervention)
BMI is measured, and change in BMI between day 0 and day 28 is used.
Change in dietary habits 1
Time frame: 6 weeks after the 4 week intervention period
Habits are compared with habits as listed before the start of the 4 week intervention period. Done through an online survey.
Change in dietary habits 2
Time frame: 6 months after the 4 week intervention period
Habits are compared with habits as listed before the start of the 4 week intervention period. Done through an online survey.
8 secondary outcomes
Dietary choices in cafeteria 1.1
Time frame: Tuesday lunch meal during the first week of the intervention
Dietary choices in cafeteria 1.2
Time frame: Thursday lunch meal during the first week of the intervention
Dietary choices in cafeteria 2.1
Time frame: Tuesday lunch meal during the second week of the intervention
Dietary choices in cafeteria 2.2
Time frame: Thursday lunch meal during the second week of the intervention
Dietary choices in cafeteria 3.1
Time frame: Tuesday lunch meal during the third week of the intervention
Dietary choices in cafeteria 3.2
Time frame: Thursday lunch meal during the third week of the intervention
Dietary choices in cafeteria 4.1
Time frame: Tuesday lunch meal during the fourth week of the intervention
Dietary choices in cafeteria 4.2
Time frame: Thursday lunch meal during the fourth week of the intervention
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 15 Aug 2019.
- BackgroundWansink, B. & Sobal, J. Mindless eating: The 200 daily food decisions we overlook. Environment and Behavior. 2007, 39(1):106-123. 2007
- Background: PubMed 19954563Rolls BJ. Plenary Lecture 1: Dietary strategies for the prevention and treatment of obesity. Proc Nutr Soc. 2010 Feb;69(1):70-9. doi: 10.1017/S0029665109991674. Epub 2009 Dec 3.
- BackgroundRozin, P., Scott, S., Dingley, M., Urbanek, J.K., Jiang, H., Kaltenbach, M. Nudge to nobesity I: Minor changes in accessibility decrease food intake. Judgment and Decision Making, 2011, 6:323-332.
- BackgroundJust, D.R. & Wansink, B. Smarter Lunchrooms: Using Behavioral Economics to Improve Meal Selection. Chocies Magazine. 2009, 24(3).
- Background: PubMed 23231863van Kleef E, Otten K, van Trijp HC. Healthy snacks at the checkout counter: a lab and field study on the impact of shelf arrangement and assortment structure on consumer choices. BMC Public Health. 2012 Dec 12;12:1072. doi: 10.1186/1471-2458-12-1072.
- 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.
Laila Dufseth principal investigator
LHL Helse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nudged to eat less added salt and more other seasonings, Nudged to avoid foods high in salt content, and to choose foods low in salt content and Nudged to eat more vegetables in people with Cardiovascular Disease and Obesity, run by LHL Helse at 1 site in Norway.
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 2 inclusion and 1 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 15 Aug 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 Norway. 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?
Change in BMI from start of intervention to end of intervention (time frame: Measured at baseline at day 0 of intervention and at completion of intervention at day 28 of intervention)). 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 NCT02808910, which also lists 5 linked publications.
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 15 Aug 2019.