Viewing Study NCT04992338



Ignite Creation Date: 2024-05-06 @ 4:28 PM
Last Modification Date: 2024-10-26 @ 2:10 PM
Study NCT ID: NCT04992338
Status: COMPLETED
Last Update Posted: 2022-03-11
First Post: 2021-07-21

Brief Title: Collaborative and Adaptive Recommender for Personalized DIEt Management
Sponsor: Fundació Eurecat
Organization: Fundació Eurecat

Study Overview

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
Status: COMPLETED
Status Verified Date: 2022-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CarpeDiem
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 users 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None