Clinical trial NCT04992338: Collaborative and Adaptive Recommender for Personalized DIEt Management
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Habit
Sleep
Life Style, Healthy
Physical Activity
Lead sponsor: Fundació Eurecat
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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 .

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mediterranean Lifestyle Index, (MEDLIFE)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reus
country: Spain
facility: Eurecat
Study officials:
References: