Overweight AdolescentsNCT06089876
The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement
A study testing STRAVA mobile application in people with Overweight Adolescents and Obesity, Adolescent, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Overweight and obesity, understood as an accumulation of abnormal and excessive fat, are the second leading cause of preventable and avoidable mortality in developed countries, with more than 340 million children and adolescents affected by this disease worldwide. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight Adolescents, Obesity, Adolescent, Physical Inactivity
- What is being tested?
- STRAVA mobile application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 25 Sep 2023to 16 Feb 2024
- 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 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be a student of compulsory secondary education
- Present an BMI > 25.0
- 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.
Who cannot join
- Failure to complete the questionnaires provided and/or to take the prescribed tests in their entirety.
- Failure to complete scheduled intervention activities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Step Tracker Mobile Applications in Overweight and Obese Adolescents for the Promotion of Physical Activity and the Improvement of Kinanthropometric Variables, Fitness and Psychological State
Overweight and obesity, understood as an accumulation of abnormal and excessive fat, are the second leading cause of preventable and avoidable mortality in developed countries, with more than 340 million children and adolescents affected by this disease worldwide. As a consequence, overweight and obesity at an early age is already considered a pandemic by the World Health Organization (WHO), with a high incidence in developed countries.
The abuse of new technologies has remained at worrying levels in the post-COVID period, favoring an increase in the adolescent population considered sedentary. In this regard, up to 70% of adolescents show sedentary behaviors, especially affecting the time spent on screens by both males (93.8%) and females (87.2%). Thus, the use of the cell phone has been shown to be a determining factor, since between 10% and 16% of adolescents show a problematic use of this device, affecting, among other aspects, their behavior during their free time.
Read more
In recent years there has been an increase in sedentary time among adolescents and a decrease in the practice of physical activity that has favored a greater accumulation of body fat and increased the probability of being overweight or obese. In this context, some studies have tried to encourage the practice of physical activity in the school context in overweight and obese population, being these interventions effective to improve body composition.
However, these interventions also have their detractors, who argue that the hours of Physical Education are too limited to dedicate so much time to a single content, and that the pedagogical component is often overlooked in their implementation. As an alternative to the above, it has been suggested that Physical Education classes could be used to promote interventions that encourage adolescents to practice physical activity in their free time, and mobile applications could be used to monitor the activity carried out by adolescents, but also as an element that generates adherence and enjoyment in this population. Research in this population using these technologies is scarce, therefore, this project aims to determine the effectiveness of a ten-week intervention promoted from the subject of physical education in which a mobile application is used after school hours on physical activity, body composition and fitness in overweight or obese adolescents.
- Conditions
- Overweight Adolescents, Obesity, Adolescent, Physical Inactivity, Mobile Phone Use, Behavior, Health
- Being tested
- STRAVA mobile application
- Medical subject headings
- Pediatric Obesity, Sedentary Behavior, Cell Phone Use, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STRAVA mobile applicationBehavioural
The adolescents in the intervention group will use the STRAVA mobile application for a period of 10 weeks. To do so, they will follow the instructions provided by the researchers on the frequency of use, the distance to be covered and how to record it.
| Study group | Role | What they receive |
|---|---|---|
| "Strava" Application | Experimental | STRAVA is an application that allows you to record your physical activity. Using GPS, it allows you to record the distance traveled with different types of physical activity (walking, running, swimming, among others). In addition, it allows you to create a community and clubs within the same community with which you can propose group trails. Receives: Behavioral: STRAVA mobile application |
| Control Group | No intervention | They will not use any type of sports technology application. They will continue to perform their daily activities without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Level
The level of physical activity was measured using the Spanish version of the physical activity questionnaire for adolescents (PAQ-A). This questionnaire is composed of nine items, the first eight of which are completed on a Likert scale of 1 to 5 points. The arithmetic mean of the scores of the first eight items provides a final physical activity score. The minimum score ranges from 1 to 5 points. A 1 indicates that the level of physical activity of adolescents is very low, while a 5 indicates that the level of physical activity is very high.
Measured: Through study completion, an average of 25 weeks
Use of internet
The Questionnaire of Experiences Related to Internet Use (CERI) will be used to analyze problematic Internet use by adolescents. This instrument is composed of 10 items that are completed on a Likert scale from 1 to 4 points (1: never; 4: almost always), with the sum of the 10 items being the final score of the questionnaire. The questionnaire indicates problematic use (PU), when the score is higher than 26 in the CERI; occasional problems (OP), when the score is between 18 and 25 in the CERI; and no problems (NP), when the score is lower than 18 in the CERI. It has been previously validated and has a Cronbach's alpha of 0.77 for CERI.
Measured: Through study completion, an average of 25 weeks
Use of mobile phone
The Questionnaire of Experiences Related to Mobile Phones (CERM) will be used to analyze problematic mobile phone use by adolescents. This instrument is composed of 10 items that are completed on a Likert scale from 1 to 4 points (1: never; 4: almost always), with the sum of the 10 items being the final score of the questionnaire. The questionnaire indicates problematic use (PU), when the score is higher than 24 in the CERM; occasional problems (OP), when the score is between 16 and 23 in the CERM; and no problems (NP), when the score is lower than 16 in the CERM. It has been previously validated and has a Cronbach's alpha of 0.80 for CERM.
Measured: Through study completion, an average of 25 weeks
Handgrip Strength
To assess upper limb strength, participants will be instructed to utilize a Takei Tkk5401 digital handheld dynamometer (Takei Scientific Instruments, Tokyo, Japan) and squeeze it with their elbow fully extended. This position is chosen because it allows for maximum force production.
Measured: Through study completion, an average of 25 weeks
VO2 max.
To assess the cardiorespiratory capacity of adolescents, the 20-m shuttle run test, an incremental test of high validity and reliability for use with adolescents, will be used. Using the formula of Léger and the speed at which the subject finishes the test, maximal oxygen consumption (VO2 max) is predicted.
Measured: Through study completion, an average of 25 weeks
Countermovement jump (CMJ)
For the CMJ, a force platform with a sampling frequency of 200 Hz (MuscleLab, Stathelle, Norway) will be used. During the CMJ test, participants will be instructed to execute a maximal vertical jump while keeping their hands on their waists and ensuring full trunk extension throughout the flight phase.
Measured: Through study completion, an average of 25 weeks
Hamstrings flexibility
To measure hamstring and lumbar flexibility, the sit-and-reach test will be used. The adolescents have to perform maximum trunk flexion, keeping their hands and knees fully extended, to reach the maximum possible distance by sliding their palms, one on top of the other, across the box.
Measured: Through study completion, an average of 25 weeks
Speed
To measure speed, the 20-m sprint will be used, in which adolescents, starting from a standing position behind a line, and initiating the run at a time of their choice, must cover 20 m in the shortest possible time. Single-beam photocells (Polifemo Light; Microgate, Italy) placed at hip height will be used for the measurement.
Measured: Through study completion, an average of 25 weeks
Curl-up
To assess abdominal muscle endurance will be use Curl-up. The highest number of repetitions the subject completes in one minute will be recorded.
Measured: Through study completion, an average of 25 weeks
Push-up
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).
Measured: Through study completion, an average of 25 weeks
Height
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%.
Measured: Through study completion, an average of 25 weeks
Weight
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
Measured: Through study completion, an average of 25 weeks
Fat mass
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.
Measured: Through study completion, an average of 25 weeks
Fat-free mass
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.
Measured: Through study completion, an average of 25 weeks
BMI
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.
Measured: Through study completion, an average of 25 weeks
Secondary outcomes (1)
User version of the Mobile Application Rating Scale
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. Engagement scores range between 5 and 25 points; functionality and information between 4 and 20; aesthetics between 3 and 15; subjective quality between 4 and 20; and perceived impact between 6 and 30. A higher score in all cases indicates a better assessment of the app.
Measured: Through study completion, an average of 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start25 Sep 2023
- Primary completion8 Dec 2023 (estimated)
- Study completion16 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight AdolescentsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Vaquero-Cristóbal, Universidad de Murcia
- Investigators
- Raquel Vaquero-Cristóbal, PhD, Principal investigator, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089876
- Sponsor's protocol ID
- AFYNNTT-ESOCARM
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mateo-Orcajada A, Ponce-Ramirez CM, Abenza-Cano L, Vaquero-Cristobal R. Effects of 10 Weeks of Walking With Mobile Step-Tracking Apps on Body Composition, Fitness, and Psychological State in Adolescents Who Are Overweight and Obese: Randomized Controlled Trial. J Med Internet Res. 2024 Dec 10;26:e55243. doi: 10.2196/55243.
PubMed 39656510
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Step Tracker Mobile Applications in Overweight and Obese Adolescents for the Promotion of Physical Activity and the Improvement of Kinanthropometric Variables, Fitness and Psychological State
- ClinicalTrials.gov ID
- NCT06089876
- Acronym / sponsor ID
- AFYNNTT-ESOCARM
- Conditions
- Overweight Adolescents, Obesity, Adolescent, Physical Inactivity, Mobile Phone Use, Behavior, Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 8 Dec 2023 (estimated)
- Study completion
- 16 Feb 2024 (estimated)
- First posted
- 19 Oct 2023 (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.
Overweight and obesity, understood as an accumulation of abnormal and excessive fat, are the second leading cause of preventable and avoidable mortality in developed countries, with more than 340 million children and adolescents affected by this disease worldwide. As a consequence, overweight and obesity at an early age is already considered a pandemic by the World Health Organization (WHO), with a high incidence in developed countries.
The abuse of new technologies has remained at worrying levels in the post-COVID period, favoring an increase in the adolescent population considered sedentary. In this regard, up to 70% of adolescents show sedentary behaviors, especially affecting the time spent on screens by both males (93.8%) and females (87.2%). Thus, the use of the cell phone has been shown to be a determining factor, since between 10% and 16% of adolescents show a problematic use of this device, affecting, among other aspects, their behavior during their free time.
In recent years there has been an increase in sedentary time among adolescents and a decrease in the practice of physical activity that has favored a greater accumulation of body fat and increased the probability of being overweight or obese. In this context, some studies have tried to encourage the practice of physical activity in the school context in overweight and obese population, being these interventions effective to improve body composition.
However, these interventions also have their detractors, who argue that the hours of Physical Education are too limited to dedicate so much time to a single content, and that the pedagogical component is often overlooked in their implementation. As an alternative to the above, it has been suggested that Physical Education classes could be used to promote interventions that encourage adolescents to practice physical activity in their free time, and mobile applications could be used to monitor the activity carried out by adolescents, but also as an element that generates adherence and enjoyment in this population. Research in this population using these technologies is scarce, therefore, this project aims to determine the effectiveness of a ten-week intervention promoted from the subject of physical education in which a mobile application is used after school hours on physical activity, body composition and fitness in overweight or obese adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Strava" Application | Experimental | Behavioral: STRAVA mobile applicationSTRAVA is an application that allows you to record your physical activity. Using GPS, it allows you to record the distance traveled with different types of physical activity (walking, running, swimming, among others). In addition, it allows you to create a community and clubs within the same community with which you can propose group trails. |
| Control Group | No intervention | –They will not use any type of sports technology application. They will continue to perform their daily activities without intervention. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Be a student of compulsory secondary education
- Present an BMI > 25.0
- 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.
Key exclusion criteria (2 listed)
- Failure to complete the questionnaires provided and/or to take the prescribed tests in their entirety.
- Failure to complete scheduled intervention activities.
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 |
|---|---|---|
| STRAVA mobile applicationThe adolescents in the intervention group will use the STRAVA mobile application for a period of 10 weeks. To do so, they will follow the instructions provided by the researchers on the frequency of use, the distance to be covered and how to record it. | Behavioural | "Strava" Application |
Primary outcome
Physical Activity Level
Time frame: Through study completion, an average of 25 weeks
The level of physical activity was measured using the Spanish version of the physical activity questionnaire for adolescents (PAQ-A). This questionnaire is composed of nine items, the first eight of which are completed on a Likert scale of 1 to 5 points. The arithmetic mean of the scores of the first eight items provides a final physical activity score. The minimum score ranges from 1 to 5 points. A 1 indicates that the level of physical activity of adolescents is very low, while a 5 indicates that the level of physical activity is very high.
Use of internet
Time frame: Through study completion, an average of 25 weeks
The Questionnaire of Experiences Related to Internet Use (CERI) will be used to analyze problematic Internet use by adolescents. This instrument is composed of 10 items that are completed on a Likert scale from 1 to 4 points (1: never; 4: almost always), with the sum of the 10 items being the final score of the questionnaire. The questionnaire indicates problematic use (PU), when the score is higher than 26 in the CERI; occasional problems (OP), when the score is between 18 and 25 in the CERI; and no problems (NP), when the score is lower than 18 in the CERI. It has been previously validated and has a Cronbach's alpha of 0.77 for CERI.
Use of mobile phone
Time frame: Through study completion, an average of 25 weeks
The Questionnaire of Experiences Related to Mobile Phones (CERM) will be used to analyze problematic mobile phone use by adolescents. This instrument is composed of 10 items that are completed on a Likert scale from 1 to 4 points (1: never; 4: almost always), with the sum of the 10 items being the final score of the questionnaire. The questionnaire indicates problematic use (PU), when the score is higher than 24 in the CERM; occasional problems (OP), when the score is between 16 and 23 in the CERM; and no problems (NP), when the score is lower than 16 in the CERM. It has been previously validated and has a Cronbach's alpha of 0.80 for CERM.
Handgrip Strength
Time frame: Through study completion, an average of 25 weeks
To assess upper limb strength, participants will be instructed to utilize a Takei Tkk5401 digital handheld dynamometer (Takei Scientific Instruments, Tokyo, Japan) and squeeze it with their elbow fully extended. This position is chosen because it allows for maximum force production.
VO2 max.
Time frame: Through study completion, an average of 25 weeks
To assess the cardiorespiratory capacity of adolescents, the 20-m shuttle run test, an incremental test of high validity and reliability for use with adolescents, will be used. Using the formula of Léger and the speed at which the subject finishes the test, maximal oxygen consumption (VO2 max) is predicted.
Countermovement jump (CMJ)
Time frame: Through study completion, an average of 25 weeks
For the CMJ, a force platform with a sampling frequency of 200 Hz (MuscleLab, Stathelle, Norway) will be used. During the CMJ test, participants will be instructed to execute a maximal vertical jump while keeping their hands on their waists and ensuring full trunk extension throughout the flight phase.
Hamstrings flexibility
Time frame: Through study completion, an average of 25 weeks
To measure hamstring and lumbar flexibility, the sit-and-reach test will be used. The adolescents have to perform maximum trunk flexion, keeping their hands and knees fully extended, to reach the maximum possible distance by sliding their palms, one on top of the other, across the box.
Speed
Time frame: Through study completion, an average of 25 weeks
To measure speed, the 20-m sprint will be used, in which adolescents, starting from a standing position behind a line, and initiating the run at a time of their choice, must cover 20 m in the shortest possible time. Single-beam photocells (Polifemo Light; Microgate, Italy) placed at hip height will be used for the measurement.
Curl-up
Time frame: Through study completion, an average of 25 weeks
To assess abdominal muscle endurance will be use Curl-up. The highest number of repetitions the subject completes in one minute will be recorded.
Push-up
Time frame: Through study completion, an average of 25 weeks
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).
Height
Time frame: Through study completion, an average of 25 weeks
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%.
Weight
Time frame: Through study completion, an average of 25 weeks
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
Fat mass
Time frame: Through study completion, an average of 25 weeks
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.
Fat-free mass
Time frame: Through study completion, an average of 25 weeks
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.
BMI
Time frame: Through study completion, an average of 25 weeks
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.
1 secondary outcome
User version of the Mobile Application Rating Scale
Time frame: Through study completion, an average of 25 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 39656510Mateo-Orcajada A, Ponce-Ramirez CM, Abenza-Cano L, Vaquero-Cristobal R. Effects of 10 Weeks of Walking With Mobile Step-Tracking Apps on Body Composition, Fitness, and Psychological State in Adolescents Who Are Overweight and Obese: Randomized Controlled Trial. J Med Internet Res. 2024 Dec 10;26:e55243. doi: 10.2196/55243.
- 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.
Raquel Vaquero-Cristóbal, PhD principal investigator
Universidad de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STRAVA mobile application in people with Overweight Adolescents and Obesity, Adolescent, run by Universidad Católica San Antonio de Murcia 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Oct 2023. 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?
Results are not available in the source record.
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?
Physical Activity Level (time frame: Through study completion, an average of 25 weeks). The study lists 15 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 NCT06089876, which also lists 1 linked publication.
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 23 Oct 2023.