Diet HabitCarpeDiemNCT04992338
Collaborative and Adaptive Recommender for Personalized DIEt Management
A study testing Mobile app in people with Diet Habit and Sleep, run by Fundació Eurecat at 1 site in Spain.
Trial summary
CarpeDiem is a mobile application which provides personalized and holistic recommendations in the area of diet, physical activity and sleep to help their users adopt a healthier lifestyle. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Habit, Sleep, Life Style, Healthy
- What is being tested?
- Mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2021to 18 Dec 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women who are between 18 and 65 years old.
- Owners of a smartphone or tablet with Android 6.0 operative system version or higher (API 23), with internet access and Bluetooth connectivity.
- Must accept the informed consent .
Who cannot join
- Pregnancy or lactation
- Having a physical limitation to perform physical activity
- Usage of another app to monitor their lifestyle habits (nutrition, physical activity or sleep)
- Have a diagnosed sleep disorder or are taking sleep medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Analyze the Effects of the Use of the Mobile Application CarpeDiem (Collaborative and Adaptive Recommender for PersonalizedDIEtManagement) on Lifestyle Habits
CarpeDiem is a mobile application which provides personalized and holistic recommendations in the area of diet, physical activity and sleep to help their users adopt a healthier lifestyle. In this study it is hypothesized that the usage of this application can achieve a more effective lifestyle improvement than an intervention with the use of wearables, their respective generic applications and general healthy lifestyle recommendations. Therefore, this study aims to assess whether the incorporation of a mobile application such as CarpeDiem, which includes smart, personalized and holistic recommendations related to a healthy lifestyle (diet, physical activity and sleep) is associated with a more pronounced change in healthy lifestyle habits than a passive monitoring approach using wearables and the administration of general recommendations.
This clinical trial consists of a multicenter pilot study performed at the headquarters of the Technology Center of Catalonia (Eurecat), randomized, parallel and controlled, performed with healthy adults (18 to 65 years old). 100 subjects will be recruited, 50 as an intervention group and 50 as a control group. The study is scheduled to begin in June 2021.
Read more
Both groups will receive an activity tracker (Fitbit Inspire HR 2). The intervention group will also receive instructions to download and use the CarpeDiem application. Through the CarpeDiem application, participants will be able to answer follow-up questionnaires, perform missions related to the healthy consumption of various food groups, monitor their physical activity and sleep, and receive periodic, personalized and holistic recommendations based on the three pillars of health. The control group will receive instructions to download the Fitbit application and will additionally receive general recommendations for healthy lifestyle habits through standardized documents. Both groups will be provided access to the initial and final questionnaires that will be done online. All participants must return the signed informed consent either with a digital signature or by mail to the Eurecat-Barcelona headquarters.
The main variable of the study is: the Mediterranean lifestyle index, calculated from the short MEDLIFE questionnaire with 28 items, validated for the Spanish adult population.
The secondary variables are:
Diet related: Food intake and food groups taken from the Food Frequency Questionnaire (CFCA). Diet diversity index calculated from the CFCA.
Related to physical activity: Total physical activity in MET-minutes / week, extracted from the IPAQ questionnaire. Data referring to daily activity (minutes sitting and moderate and intense physical activity and number of steps taken) measured with the activity bracelet.
Sleep-related: Sleep quality index, derived from the Pittsburg Sleep Quality Questionnaire (PSQI). Data referring to users' daily sleep (sleep duration, efficiency, start and end) measured with the activity bracelet.
Related to the user's experience in using the application, evaluated through the UEQ questionnaire. Only at the end of the intervention.
In total, subjects will receive 3 visits:
Visit 0, pre-screening visit before randomization to check inclusion / exclusion criteria, using an online form.
Visit 1, after randomization, inclusion visit. Participants will receive the activity bracelet and informed consent at their homes. During this visit, participants will answer the questionnaires using online forms.
Visit 2, after three months, final visit of the study intervention. Participants will answer the questionnaires using online forms.
- Conditions
- Diet Habit, Sleep, Life Style, Healthy, Physical Activity
- Being tested
- Mobile app
- Medical subject headings
- Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appDevice
The CarpeDiem application is a mobile application, designed in collaboration with the Health and Nutrition Technology Unit (UTNS, Eurecat) and the translational research group on respiratory medicine of the Institut de Recerca Biomèdica de Lleida. The application is available for devices with Android as the operative system and its advanced interface allows the user to monitor their physical activity, sleep and diet and motivate them to meet personalized goals through gamification. To do this, the user must answer the questionnaires that they will find on the main page of the application with a predetermined frequency, as well as perform missions that will help them acquire healthier habits. In addition, the user will receive motivational messages and recommendations through notifications that will help and guide them to achieve their missions and achieve their goals, and as a result of changing habits.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - CarpeDiem app | Experimental | Participants will receive at their home the activity tracker of Fitbit brand, model Inspire HR 2, as well as instructions to download and use the CarpeDiem application and the Fitbit application in their mobile phones and synchronize the bracelet. The intervention consists of detecting unhealthy user behaviors and, through contextualized and personalized recommendations and strategies based on gamification, modifying said behaviors and motivating individuals to maintain this modification over time in order to prevent illnesses associated with bad habits. The intervention is performed through the CarpeDiem application, participants will be able to answer follow-up questionnaires, carry out missions designed to improve their eating habits, monitor their physical activity and sleep. Receives: Device: Mobile app |
| Control group - Activity tracker + general recommendations | No intervention | Participants will receive the Fitbit activity tracker, model Inspire HR 2. They will also receive instructions to download the Fitbit application from their mobile phone and synchronize the bracelet. Additionally, this group will receive general recommendations on healthy lifestyle habits through standardized documents that contain general guidelines, such as: "Get in the habit of going to sleep and always waking up at the same time, even on weekends." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mediterranean Lifestyle Index, (MEDLIFE)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start30 Jun 2021
- Primary completion28 Nov 2021
- Study completion18 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Eurecat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992338
- Sponsor's protocol ID
- 2
- Acronym
- CarpeDiem
- Status last verified
- Mar 2022
- First submitted
- 21 Jul 2021
- Last updated
- 11 Mar 2022
- 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 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Analyze the Effects of the Use of the Mobile Application CarpeDiem (Collaborative and Adaptive Recommender for PersonalizedDIEtManagement) on Lifestyle Habits
- ClinicalTrials.gov ID
- NCT04992338
- Acronym / sponsor ID
- CarpeDiem / 2
- Conditions
- Diet Habit, Sleep, Life Style, Healthy, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundació EurecatUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- 18 Dec 2021 (actual)
- First posted
- 5 Aug 2021 (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.
CarpeDiem is a mobile application which provides personalized and holistic recommendations in the area of diet, physical activity and sleep to help their users adopt a healthier lifestyle. In this study it is hypothesized that the usage of this application can achieve a more effective lifestyle improvement than an intervention with the use of wearables, their respective generic applications and general healthy lifestyle recommendations. Therefore, this study aims to assess whether the incorporation of a mobile application such as CarpeDiem, which includes smart, personalized and holistic recommendations related to a healthy lifestyle (diet, physical activity and sleep) is associated with a more pronounced change in healthy lifestyle habits than a passive monitoring approach using wearables and the administration of general recommendations.
This clinical trial consists of a multicenter pilot study performed at the headquarters of the Technology Center of Catalonia (Eurecat), randomized, parallel and controlled, performed with healthy adults (18 to 65 years old). 100 subjects will be recruited, 50 as an intervention group and 50 as a control group. The study is scheduled to begin in June 2021.
Both groups will receive an activity tracker (Fitbit Inspire HR 2). The intervention group will also receive instructions to download and use the CarpeDiem application. Through the CarpeDiem application, participants will be able to answer follow-up questionnaires, perform missions related to the healthy consumption of various food groups, monitor their physical activity and sleep, and receive periodic, personalized and holistic recommendations based on the three pillars of health. The control group will receive instructions to download the Fitbit application and will additionally receive general recommendations for healthy lifestyle habits through standardized documents. Both groups will be provided access to the initial and final questionnaires that will be done online. All participants must return the signed informed consent either with a digital signature or by mail to the Eurecat-Barcelona headquarters.
The main variable of the study is: the Mediterranean lifestyle index, calculated from the short MEDLIFE questionnaire with 28 items, validated for the Spanish adult population.
The secondary variables are:
Diet related: Food intake and food groups taken from the Food Frequency Questionnaire (CFCA). Diet diversity index calculated from the CFCA.
Related to physical activity: Total physical activity in MET-minutes / week, extracted from the IPAQ questionnaire. Data referring to daily activity (minutes sitting and moderate and intense physical activity and number of steps taken) measured with the activity bracelet.
Sleep-related: Sleep quality index, derived from the Pittsburg Sleep Quality Questionnaire (PSQI). Data referring to users' daily sleep (sleep duration, efficiency, start and end) measured with the activity bracelet.
Related to the user's experience in using the application, evaluated through the UEQ questionnaire. Only at the end of the intervention.
In total, subjects will receive 3 visits:
Visit 0, pre-screening visit before randomization to check inclusion / exclusion criteria, using an online form.
Visit 1, after randomization, inclusion visit. Participants will receive the activity bracelet and informed consent at their homes. During this visit, participants will answer the questionnaires using online forms.
Visit 2, after three months, final visit of the study intervention. Participants will answer the questionnaires using online forms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - CarpeDiem app | Experimental | Device: Mobile appParticipants will receive at their home the activity tracker of Fitbit brand, model Inspire HR 2, as well as instructions to download and use the CarpeDiem application and the Fitbit application in their mobile phones and synchronize the bracelet. The intervention consists of detecting unhealthy user behaviors and, through contextualized and personalized recommendations and strategies based on gamification, modifying said behaviors and motivating individuals to maintain this modification over time in order to prevent illnesses associated with bad habits. The intervention is performed through the CarpeDiem application, participants will be able to answer follow-up questionnaires, carry out missions designed to improve their eating habits, monitor their physical activity and sleep. |
| Control group - Activity tracker + general recommendations | No intervention | –Participants will receive the Fitbit activity tracker, model Inspire HR 2. They will also receive instructions to download the Fitbit application from their mobile phone and synchronize the bracelet. Additionally, this group will receive general recommendations on healthy lifestyle habits through standardized documents that contain general guidelines, such as: "Get in the habit of going to sleep and always waking up at the same time, even on weekends." |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women who are between 18 and 65 years old.
- Owners of a smartphone or tablet with Android 6.0 operative system version or higher (API 23), with internet access and Bluetooth connectivity.
- Must accept the informed consent .
Key exclusion criteria (4 listed)
- Pregnancy or lactation
- Having a physical limitation to perform physical activity
- Usage of another app to monitor their lifestyle habits (nutrition, physical activity or sleep)
- Have a diagnosed sleep disorder or are taking sleep medication
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 |
|---|---|---|
| Mobile appThe CarpeDiem application is a mobile application, designed in collaboration with the Health and Nutrition Technology Unit (UTNS, Eurecat) and the translational research group on respiratory medicine of the Institut de Recerca Biomèdica de Lleida. The application is available for devices with Android as the operative system and its advanced interface allows the user to monitor their physical activity, sleep and diet and motivate them to meet personalized goals through gamification. To do this, the user must answer the questionnaires that they will find on the main page of the application with a predetermined frequency, as well as perform missions that will help them acquire healthier habits. In addition, the user will receive motivational messages and recommendations through notifications that will help and guide them to achieve their missions and achieve their goals, and as a result of changing habits. | Device | Intervention group - CarpeDiem app |
Primary outcome
Mediterranean Lifestyle Index, (MEDLIFE)
Time frame: 3 months
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 11 Mar 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile app in people with Diet Habit and Sleep, run by Fundació Eurecat at 1 site in Spain.
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 4 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 11 Mar 2022. 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 Spain. 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?
Mediterranean Lifestyle Index, (MEDLIFE) (time frame: 3 months). 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 11 Mar 2022.