Adolescents' Health Through Mobile Apps, Wearables, and a Gamified TAC ( ActivA-App ) (ActivA-App)

November 14, 2023 updated by: Raquel Vaquero-Cristóbal, Universidad Católica San Antonio de Murcia

Promotion of Daily Recommended Physical Activity for Adolescents' Health Through Mobile Apps, Wearables, and a Gamified TAC

A primary factor in preventing diseases in adulthood, as well as overweight and obesity, is the promotion of physical activity from childhood and adolescence. Although the recommendations for practicing physical activity at this stage are broad, low rates of practice that do not comply with the recommendations are reported. There is a high percentage of use of new technologies, particularly mobile applications, they have been used with some success to improve the health of similar populations, although its use for this purpose has certain limitations. Therefore, this project will investigate whether the use of various mobile and wearable applications can be an effective way to periodically increase physical activity levels and establish new healthy habits that improve the present and future health of adolescents. Several secondary education centers in the Region of Murcia will participate in this project. The objective is to obtain relevant results that can serve as a starting point for other interventions at a national or international level.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The promotion of physical activity among young people has become a crucial factor in preventing adult-onset diseases, particularly overweight and obesity, and in improving health and well-being during this stage. The World Health Organization (WHO) recommends 60 minutes of moderate aerobic activity per day (or the equivalent in vigorous activity) and at least three days a week of strength-resistance exercises for children and adolescents. However, surveys on the physical activity habits of Spanish adolescents indicate that more than 50% do not meet these recommendations. Excessive use of new technologies has been identified as a predisposing factor for decreased physical activity, a habit that is increasingly common among adolescents. This, combined with the sedentary conditions brought about by the COVID-19 pandemic, has led to a significant increase in sedentary behavior among the young population. Nevertheless, new technologies, particularly mobile applications, have been used with some success to improve the health of similar populations, although their use for this purpose has certain limitations. Therefore, this project aims to address the decline in physical activity among the adolescent population and provide resources that will endure over time to promote physical activity among adolescents within the educational sphere. It's worth noting that during the period of Compulsory Secondary Education (ESO), there are only two hours of Physical Education (PE) per week, making it impossible to meet the recommended levels of practice solely through school-based physical activity. Thus, it is necessary to create resources that encourage physical activity in leisure time, involving both students and teachers, and that can also be utilized by future generations. This project builds upon prior research in promoting physical activity through Information and Communication Technologies (ICTs), but adapts it to a more sedentary social context, vastly different from before, requiring new strategies to increase physical activity in adolescents and thereby promote the preservation of physical and mental health following the inactivity imposed by the COVID-19 lockdown. Therefore, this project will investigate whether the use of various mobile applications and wearables can be an effective way to regularly increase physical activity levels and establish new healthy habits that improve both present and future health for adolescents. Additionally, it aims to provide teachers and students with an application that effectively encourages physical activity within the educational context, guided by professionals in Physical Activity and Sports Sciences, yet remains engaging and motivating for continued use. This will allow for a combination of physical activity and education within the context of Technology-Enhanced Learning and Communication (TAC). This project will involve several secondary education centers in the Region of Murcia, as it is one of the autonomous communities with higher levels of inactivity, overweight, and obesity in early ages. The goal is to obtain relevant results that can serve as a starting point for other interventions at a national or international level.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Be a student of compulsory secondary education
  • Not present any disease or surgical operation that would prevent the performance of the physical tests or the follow-up of the established intervention.
  • Complete the questionnaires provided and carry out the established tests in their entirety
  • Have access to any mobile device that allows access to the technological sports applications used in the intervention.

Exclusion Criteria:

  • Failure to complete the questionnaires provided and/or to take the prescribed tests in their entirety
  • Failure to complete scheduled intervention activities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: "MapMyWalk" Application
It is an application that promotes the practice of physical activity by recording the sports activities that the subject performs, as well as the dissemination of the same in social networks and participation in challenges available to users around the world. In addition, this application includes reminders of physical activity and personal achievements to encourage the practice of sports.
Behavioral: "MapMyWalk" Application
It is an application that promotes the practice of physical activity by recording the sports activities that the subject performs, as well as the dissemination of the same in social networks and participation in challenges available to users around the world. In addition, this application includes reminders of physical activity and personal achievements to encourage the practice of sports.
Experimental: "POKEMON GO" APPLICATION
It is a mobile game that favors the increase of physical activity because it is necessary to walk to achieve the proposed objectives.
Behavioral: "POKEMON GO" APPLICATION
It is a mobile game that favors the increase of physical activity because it is necessary to walk to achieve the proposed objectives.
No Intervention: Control Group
They will not use any type of sports technology application. They will continue to perform their daily activities without intervention.
Experimental: "PACER" Application
It is an application that allows the recording of the sports activities performed. It includes alerts and reminders that allow the participant to plan his/her sports practice in advance, as well as a weekly record of the activities and kilometers run, and a comparative analysis with the previous week.
Behavioral: "PACER" Application
It is an application that allows the recording of the sports activities performed. It includes alerts and reminders that allow you to plan your sports practice in advance, as well as a weekly record of the activities and kilometers run, and a comparative analysis with the previous week.
Experimental: "Strava" Application
It is an application that promotes sports practice, nutritional habits and the necessary rest. Nutrition and sleep will be introduced as variables that favor a healthy lifestyle
Behavioral: "Strava" Application
It is an application that promotes sports practice, nutritional habits and the necessary rest. Nutrition and sleep will be introduced as variables that favor a healthy lifestyle.
Experimental: "JEFIT" APPLICATION
It is an app whose goal is to be a support in training of strength-resistance training. Setting a specific goal, with a full databaseover of exercises to perform.
Behavioral: "JEFIT" APPLICATION
It is an app whose goal is to be a support in training of strength-resistance training. Setting a specific goal, with a full databaseover of exercises to perform.
Experimental: "FITBIT-FLEX" APPLICATION
It is a physical activity wereable. It acts as a witness to physical activity and transmits the data to the computer or smartphone.
Behavioral: "FITBIT-FLEX" APPLICATION
It is a physical activity wereable. It acts as a witness to physical activity and transmits the data to the computer or smartphone.
Experimental: "MEIZU BONG 2S" APPLICATION
It is a physical activity wereable. It acts as a witness to physical activity and transmits the data to the computer or smartphone.
Behavioral: "MEIZU BONG 2S" APPLICATION
It is a physical activity wereable. It acts as a witness to physical activity and transmits the data to the computer or smartphone.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical Activity Level (International Physical Activity Questionnaire for Adolescents)
Time Frame: Pre-test, week 10, week 20 and week 24
The PAQ-A (Martínez-Gómez et al., 2009) will be used to establish the level of sports practice of the adolescents. This questionnaire includes eleven questions related to the practice of physical activity in school, after school, household chores and travel. The questionnaire makes it possible to classify adolescents as inactive or active (light, moderate or vigorous intensity). The questionnaire reports the time in hours and minutes that the participant performs physical activity. The longer the time, the better the result.
Pre-test, week 10, week 20 and week 24
Physical activity level (accelerometry)
Time Frame: Pre-test, week 10, week 20 and week 24
In a subset of secondary school students (n=30), physical activity will be analyzed using accelerometry with the Actigraph GT3X+Tri-Axis Accelerometer Monitor (Actigraph, Pensacola, Florida). To do this, participants will be asked to wear the accelerometer on their non-dominant hand continuously for seven consecutive days and nights. They will be instructed not to move the accelerometer during the measurement period (Hjorth et al., 2012).
Pre-test, week 10, week 20 and week 24
Use of internet (CERI Questionnaire)
Time Frame: Pre-test, week 10, week 20 and week 24
To measure the frequency of Internet use through new communication technologies, the CERI questionnaire (Fargues et al. 2009) will be used, which includes 10 questions rated on a scale of 1 to 4, with 1 being "almost never" and 4 "almost always". The questionnaire reports a number from 10 to 40, with the higher value being more use.
Pre-test, week 10, week 20 and week 24
Use of mobile phone (CERM Questionnaire)
Time Frame: Pre-test, week 10, week 20 and week 24.
To measure the frequency of cell phone use, regardless of whether it is for social networks, video games, etc., the CERM questionnaire (Fargues et al. 2009) will be used, which includes 10 questions rated on a scale of 1 to 4, with 1 being "almost never" and 4 being "almost always". The questionnaire reports a number from 10 to 40, with the higher value being a more use.
Pre-test, week 10, week 20 and week 24.
Satisfaction with life (Life Satisfaction Scale)
Time Frame: Pre-test, week 10, week 20 and week 24
Life satisfaction is defined as a person's overall evaluation of his or her life. The person examines the tangible aspects of his or her life and compares them with a standard or criterion chosen by him or her, arriving at a judgment about satisfaction with his or her life (Pavot et al., 1991). Thus, judgments about satisfaction depend on the comparisons the subject makes between the circumstances of his or her life and a standard that he or she considers appropriate. The life satisfaction scale (Diener et al., 1985) provides information on feelings of happiness, feelings of loneliness and satisfaction in school among adolescents, obtaining an overall assessment of life satisfaction. The scale is composed of five questions that are answered on a scale of 1 to 5, with 1 being "strongly disagree" and 5 "strongly agree". The minimum score will be 5 and the maximum 25 points. A higher score indicates greater satisfaction with life.
Pre-test, week 10, week 20 and week 24
Physical condition (Maximal oxygen consumption)
Time Frame: Pre-test, week 10, week 20 and week 24
The 20-m shuttle run test evaluates maximal aerobic capacity by means of an incremental 20-meter out-and-back test. The initial speed of the test is 8.5 km/h and is increased every minute by an audible signal. The test ends when the subject stops or fails to reach the reference line two consecutive times. The speed recorded is the speed reached in the last stage that the subject is able to complete. Through the equations of Leger, Mercier, Gadoury and Lambert (1988) the reference value of the subject's VO2 max. is obtained.
Pre-test, week 10, week 20 and week 24
Physical condition (Handgrip Strength)
Time Frame: Pre-test, week 10, week 20 and week 24
The test will provide information about the isometric force (kg) that the participant is able to develop with the forearm musculature. For this purpose, a digital dynamometer with manual grip (5030J1, Jamar ®, Sammons Preston, United Kingdom) will be used. Prior to the execution, the instrument will be adjusted according to the age of the player and the length of his/her hand. Two measurements will be taken with each arm, with a one minute rest between them. The participant must hold the dynamometer with the executing hand and the arm extended along the torso, without contacting it, and produce the maximum force possible (Rojas, Vázquez, Sánchez, Banik, & Argáez, 2012; Valdes & Yanci, 2016). Manual grip strength determined by dynamometer is significantly associated with proper cardiovascular health in adolescents, so its analysis is of interest as part of an assessment of global physical fitness (García-Hermoso et al., 2019).
Pre-test, week 10, week 20 and week 24
Physical condition (Lower extremity muscle strength)
Time Frame: Pre-test, week 10, week 20 and week 24
The countermovement jump test (CMJ) will be used to measure this variable. This test provides information on the explosive strength of the lower body. The CMJ is a vertical jump that begins with the subject in a standing position, followed by knee flexion to a position of approximately 90 degrees, and a rapid extension of the knees to perform a jump in which the maximum height is reached. It should be noted that there is no stop in the knee flexion position since the intention is to take advantage of the explosive elastic reflex energy of the movement. The subjects will perform two repetitions of the jump 2 minutes apart. A MuscleLab force platform (Ergotest Innovation S.A., Norway) will be used to record the data, which will measure the time of flight from the time the subject takes off from the platform to the time the subject re-enters contact with the platform.
Pre-test, week 10, week 20 and week 24
Physical condition (Hamstrings Flexibility)
Time Frame: Pre-test, week 10, week 20 and week 24
The sit-and-reach test will be used. A 30-centimeter measuring box (Finder Flex-Tester, Novel Products, USA) with a millimeter ruler is required. In the initial position, the subject should be in a seated position, with knees fully extended feet hip-width apart and soles of the feet perpendicular to the floor and in contact with the box. The subject will be asked to place one hand on top of the other, with the palms of the hands facing downward and the fingers stretched out. The subject will perform a neck flexion to bring the chin to the chest and a trunk flexion with the knees fully stretched and without ballistic movements, trying to reach the greatest possible distance and maintaining the posture for 3 seconds. The distance will be measured in centimeters and the value 0 will correspond to the tangent of the soles of the feet, the values being positive when this distance is exceeded, and negative when it is not reached.
Pre-test, week 10, week 20 and week 24
Physical condition (horizontal jump)
Time Frame: Pre-test, week 10, week 20 and week 24.]
Upper lower body strength is measured form a standing position with feet approximately shoulder´s width apart. Participant jump as far forward as possible. The test is performance twice. The longest distance achieved was recorded in centimeters20.
Pre-test, week 10, week 20 and week 24.]
Anthropometric Variables (Height)
Time Frame: Pre-test, week 10, week 20 and week 24
To measure height, a SECA measuring rod should be used. Adolescents should stand barefoot with their backs against the measuring rod, heels of their feet together and their gaze straight ahead. Measurements will be obtained in centimeters and will be repeated 2 times for each subject. A third measurement will only be taken if the difference between the first and second measurement is greater than 1%.
Pre-test, week 10, week 20 and week 24
Anthropometric Variables (Weight)
Time Frame: Pre-test, week 10, week 20 and week 24.]
A Tanita BC 418-MA Segmental scale (Tanita, Tokyo) will be used to measure body weight. The subject will step on the scale with both feet inside the scale and looking straight ahead, without leaning the body. Values will be obtained in kilograms and two measurements will be carried out on each subject. If the difference between both measurements is greater than 1%, a third measurement will be taken
Pre-test, week 10, week 20 and week 24.]
Anthropometric Variables (Fat mass)
Time Frame: Pre-test, week 10, week 20 and week 24.
To obtain the fat mass, it will be necessary to previously measure the triceps, thigh and leg folds, and the waist, hip, relaxed arm, thigh and leg perimeters. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the fat mass can be calculated using the formula of Slaughter et al. (1988)
Pre-test, week 10, week 20 and week 24.
Anthropometric Variables (Fat-free mass)
Time Frame: Pre-test, week 10, week 20 and week 24.
To obtain the fat-free mass, it will be necessary to previously measure the triceps, thigh and leg folds, and the perimeters of the waist, hip, relaxed arm, thigh and leg. For these previous measurements, two measurements will be taken in each subject, and a third measurement will be necessary if the difference between the first two is greater than 5%. Once the values of the previous measurements have been obtained, the-fat free mass can be calculated using the formula of Poortmans et al. (2005)
Pre-test, week 10, week 20 and week 24.
Physical condition (upper limb strength)
Time Frame: Pre-test, week 10, week 20 and week 24
To assess upper limb strength will be used Push-up test. The subject will perform as many repetitions as possible in one minute, or until reaching exhaustion (Castro-Piñero et al., 2010).
Pre-test, week 10, week 20 and week 24
Physical condition (Curl-up)
Time Frame: Pre-test, week 10, week 20 and week 24
To assess abdominal muscle endurance will be use Curl-up. The highest number of repetitions the subject completes in one minute will be recorded (García-Pastor et al., 2016).
Pre-test, week 10, week 20 and week 24
Physical condition (Maximum speed)
Time Frame: Pre-test, week 10, week 20 and week 24.
To assess maximum speed will be used 20-m sprint. A maximum speed sprint over 20 meters will be performed, following the protocol of previous research (García-Manso et al., 1996). Photocells placed at hip height will be used for timing quantification (Altmann et al., 2017).
Pre-test, week 10, week 20 and week 24.
Anthropometric Variables (BMI)
Time Frame: Pre-test, week 10, week 20 and week 24.
Previously obtained height and weight measurements will be used to establish the BMI. The formula used will be weight/height^2, and the result will be obtained in kg/m^2. This index is commonly used and is related to metabolic and cardiovascular diseases in adolescents and adults.
Pre-test, week 10, week 20 and week 24.
Satisfaction and frustration of basic psychological needs
Time Frame: Pre-test, week 10, week 20 and week 24.
This questionnaire is made up of 24 items grouped into six factors and analyze different basic psychological needs, as described in the Self-Determination Theory (SDT), developed by Deci and Ryan. Autonomy is evaluated by four items, relatedness is evaluated by four items, and competence by four items. The frustration of each of the basic psychological needs, in turn, is evaluated by four elements each. The 14 items will be evaluated through a five-point Likert-type scale, ranging from 1 (completely false) to 5 (completely true). All factors values range 4 and 20 points. Higher scores report a better score in the factor.
Pre-test, week 10, week 20 and week 24.
Motivation in Physical Education Classes
Time Frame: Pre-test, week 10, week 20 and week 24.
To assess motivation towards physical education classes, the Perceived Locus of Causality Scale (PLOC) has been used. This scale is made up of 20 items on a 7-point Liker scale from completely agree to completely disagree. These items evaluate 5 factors: intrinsic motivation, identified regulation, introjected regulation, external regulation and amotivation. All factors values range 1 and 7 points. Higher scores report a better score in the factor.
Pre-test, week 10, week 20 and week 24.
Fat percentage
Time Frame: Pre-test, week 10, week 20 and week 24.
It will assessed by bioimpedance in percentage, following the recommendations of Brantlov et al. (2017) for proper execution.
Pre-test, week 10, week 20 and week 24.
Hydration percentage
Time Frame: Pre-test, week 10, week 20 and week 24.
It will assessed by bioimpedance in percentage, following the recommendations of Brantlov et al. (2017) for proper execution.
Pre-test, week 10, week 20 and week 24.
Muscle mass
Time Frame: Pre-test, week 10, week 20 and week 24.
It will assessed by bioimpedance in kilogramers, following the recommendations of Brantlov et al. (2017) for proper execution.
Pre-test, week 10, week 20 and week 24.
Bone weight
Time Frame: Pre-test, week 10, week 20 and week 24.
It will assessed by bioimpedance, in kilogramers, following the recommendations of Brantlov et al. (2017) for proper execution.
Pre-test, week 10, week 20 and week 24.
Visceral fat
Time Frame: Pre-test, week 10, week 20 and week 24.
It will assessed by bioimpedance in kilogramers, following the recommendations of Brantlov et al. (2017) for proper execution.
Pre-test, week 10, week 20 and week 24.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Healthy lifestyle habits (Survey on Healthy Habits in Adolescents)
Time Frame: Pre-test, week 10, week 20 and week 24
The "Survey on Healthy Habits in Adolescents" (ENHASA) will be used. This questionnaire consists of 26 items that are completed using a Likert scale of 0-10 points, addressing four dimensions related to the main risk factors: nutrition, physical activity, new technologies, and environment. The final score allows for the following classification: very poor habits, poor, acceptable, good, and very good (Carpena-Lucas et al., 2022; Jiménez-Candel et al., 2021).
Pre-test, week 10, week 20 and week 24
Evaluation of ICTs (User version of the Mobile Application Rating Scale)
Time Frame: week 10
The User version of the Mobile Application Rating Scale (uMARS) is a scale consisting of 26 items completed using a Likert scale ranging from 1 to 5 points. This scale allows for the assessment of 6 dimensions, which include engagement, functionality, aesthetics, information, subjective quality, and perceived impact of the mobile application (Martin-Payo et al., 2021). All factors values range 1 and 5 points. Higher scores report a better score in the factor
week 10
Biological maturation
Time Frame: Pre-test, week 10, week 20 and week 24.
Biological maturation will also be assessed since it can be crucial during this stage of development. To do this, the sexspecific formula from Mirwald et al. (2002) will be used to estimate the maturation offset of the adolescents. Based on the maturation offset, the biological maturation of each subject will be calculated (Albaladejo-Saura et al., 2022).
Pre-test, week 10, week 20 and week 24.
Academic performance
Time Frame: Week 10, week 20 and week 24.]
The educational institution will be asked for the academic record of the academic year in which the measurements are conducted for the participating students in order to establish the relationship between the level of physical activity and academic performance. Academic performance will be obtained with the average grade of all the subjects taken by the participant in the course in which the program is developed. This average grade will be provided by the school.
Week 10, week 20 and week 24.]
Mediterranean Diet Quality (KIDMED Questionnaire)
Time Frame: Pre-test, week 10, week 20 and week 24
The KIDMED questionnaire (Serra-Majem et al., 2004) will be used to establish the level of adherence of adolescents to the Mediterranean diet. It consists of 16 questions that are scored with a value of -1 if they denote a negative connotation with respect to the Mediterranean diet, or with a +1 if they are positive in relation to the diet. The index ranges from 0 to 12 points and the results are classified as: optimal Mediterranean diet (>8 points), requires improvement to adjust intake to Mediterranean patterns (4-7 points), and very low diet quality (≤ 3 points). The questions included in the questionnaire are related to the main foods included in this type of diet (fruit, vegetables, bread, etc.).
Pre-test, week 10, week 20 and week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Católica San Antonio de Murcia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raquel Vaquero-Cristobal, PhD, Universidad de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Project ActivA-App
  • PID2022-140245OA-I00 (Other Grant/Funding Number: Ministerio de Ciencia e Innovación)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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