Adolescent ObesityNCT05329753
Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents
A study testing Mobile health application in people with Adolescent Obesity, run by University of Cadiz at 1 site in Spain.
Trial summary
The prevention of overweight and obesity in adolescents is a public health priority given the impact of obesity on both short- and long-term health. Scientific evidence has shown that interventions in diet and physical exercise can reduce the risk of obesity in children and young people since adolescence is an ideal… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Obesity
- What is being tested?
- Mobile health application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2019to 30 Jun 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Adolescents who were studying the 1st to 3rd grades of secondary education in public institutes
- Have a smartphone or tablet with an Android operating system and internet access
Who cannot join
- Adolescents with barriers that prevented them from understanding the characteristics of the study: Comprehension, visual or auditory problems
- Adolescents with disease or treatment that affect the variables studied (diagnosed diseases that affect body weight such as liver or kidney disease or regular treatment with drugs such as corticosteroids)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents on Sport and Nutrition Knowledge, Eating Habits and Physical Activity: A Randomized Clinical Trial
The prevention of overweight and obesity in adolescents is a public health priority given the impact of obesity on both short- and long-term health. Scientific evidence has shown that interventions in diet and physical exercise can reduce the risk of obesity in children and young people since adolescence is an ideal stage for educating on a healthy lifestyle and correcting the habits that may have been acquired in childhood. Smartphone applications (apps) can provide a useful alternative to overweight and obesity prevention measures.
The objective of this study was to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a mobile health application (m-Health) on improving the degree of sport and nutrition knowledge, eating habits, and level of physical activity of adolescents.
The sample consists of 305 adolescents, 154 in the intervention group and 151 in the control group that are evaluated at the beginning and 6 months later regarding sociodemographic, eating habits, food knowledge, level of physical activity, body mass index, and waist circumference. The educational intervention was carried out using an m-Health tool, a mobile phone application. The outcomes were changes in the mentioned variables to a six-month follow-up between the two groups.
Read the detailed description
Design: A randomized parallel-group, controlled clinical trial was performed on adolescents from public secondary schools in the province of Cadiz, Spain.
Randomization and Blinding: The randomization and allocation to each group (1:1, intervention, and usual care) are based on computer-generated random numbers stratified in the three courses of secondary education. The researchers responsible for the study do not participate in the allocation of the participants. Due to the kind of intervention, blinding is not possible when the participants are allocated to groups. To minimize any bias, objective clinical variables are measured during the evaluation visit and the analyses are performed by blinded researchers.
Study Sample: The estimated sample size to detect a mean difference of at least one point in the level of healthy eating habits, measured by the KidMed questionnaire, with a standard deviation of the values in the questionnaire known from previous studies of 2.5 points, a level of confidence of 95% and statistical power of 90%, it was 126 participants in each group, intervention, and control. Assuming a 20% loss to follow-up, 305 participants were recruited, 154 in the intervention group and 151 in the control group.
Recruitment: All participants, in the intervention and control groups, received an Intervention on healthy habits consisting of four sessions developed by a nurse over two months. Adolescents who voluntarily decided to participate in the mobile Health educational intervention were recruited by a nurse. Both the adolescents and their parents signed the informed consent.
Intervention: The nurse installs the application on the mobile phone of the participants in the intervention group. It is a friendly, easy-to-use application for smartphones and tablets that favors the process of learning while playing.
Application Contents: Through the application, the adolescent participates in five activities: food, exercises, tests, learning more, and games that are different from each other but interconnected and that allow progress to be seen. The application "Care your habits" has educational materials on nutrition and physical activity. The participant records the food eaten and the physical activity performed, in addition to answering health questionnaires.
Technical Data of the Application:
The application has been developed for Android mobiles with versions between API 16 and API 28, which guarantees user compatibility. This app uses Firebase, a cloud platform that enables certain features, such as a secure login for app users. The application uses an initial Activity, which is responsible for managing the Login. The application is structured in different Fragments. Each of these Fragments is made up of a layout that is the graphical interface that the user sees and a class in the Java programming language that is the part in charge of processing the user's interaction with the interface and performing the appropriate action.
The app needs a server that manages interactions with the database where the data that users provide voluntarily from the app itself is stored. The part of the server that supports and complements the Android application is made up of a RESTful API developed in the NodeJS programming language. This server communicates with Firebase in order to verify the identity of the user who is providing data at all times, so that a user could not falsify another user's data.
All of this information is persistently stored in a NoSQL database, specifically a MongoDB database. The information provided by users is encrypted to prevent data theft.
Ethical Considerations: The study was conducted in agreement with the guidelines and protocols established in the Helsinki Declaration as revised in Fortaleza (Brazil) in October 2013, and complies with Law 14/2007 on Biomedical Research and with European Data Protection Regulations. The Biomedical Research Ethics Committee of Cádiz, Andalusian, approved the project with the reference: 11_02_2019. The informed written consent of all the participants and their parents was requested. The application guarantees security measures regarding the current General Data Protection Regulations in Europe. It also includes data encryption mechanisms.
- Conditions
- Adolescent Obesity
- Being tested
- Mobile health application
- Keywords
- mobile application, eating habits, physical activity, overweight, nutrition knowledge
- Medical subject headings
- Pediatric Obesity, Feeding Behavior, Motor Activity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health applicationDevice
Health intervention through a smartphone application that favors the process of learning
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Mobile application Receives: Device: Mobile health application |
| Control group | No intervention | Usual education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating habits
KidMed: A 16-item Questionnaire of Mediterranean diet adherence (unit of measure: points. Each item is scored 0 or 1. The total Mediterranean diet score ranges from 0 to 12 points. The higher the score, the higher the degree of adherence to the Mediterranean Diet).
Measured: 6 months
Nutrition knowledge
General and Sport Nutrition knowledge Questionnaire: A questionnaire with 62 items (unit of measure: points. The higher the score, the higher the knowledge level)
Measured: 6 months
Level of physical activity
Physical Activity Questionnaire for adolescents (PAQ-A) (The overall result of the test is a score from 1 to 5 points that allows to establish a graduation in the level of physical activity made by each adolescent. Do higher values represent a better outcome)
Measured: 6 months
Secondary outcomes (2)
Body mass index
Body mass index is calculated as weight in kilograms divided by height in meters squared. The WHO tables for adolescents by age and sex were used to classify the body mass index of adolescents as normal, overweight, and obese.
Measured: 6 months
Waist circumference
Waist circumference was defined as the smallest abdominal circumference between the lowest rib and the upper anterior iliac spine.
Percentile tables for Spanish adolescents by age and sex were used
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start15 Sep 2019
- Primary completion5 May 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ObesityStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M J Santi, MD, Principal investigator, University of Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329753
- Sponsor's protocol ID
- PI-77.18 EIESOJTIC18
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2022
- Last updated
- 15 Apr 2022
- Results posted
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents on Sport and Nutrition Knowledge, Eating Habits and Physical Activity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05329753
- Acronym / sponsor ID
- PI-77.18 EIESOJTIC18
- Conditions
- Adolescent Obesity
- Keywords
- mobile application, eating habits, physical activity, overweight, nutrition knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Apr 2022 (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.
The prevention of overweight and obesity in adolescents is a public health priority given the impact of obesity on both short- and long-term health. Scientific evidence has shown that interventions in diet and physical exercise can reduce the risk of obesity in children and young people since adolescence is an ideal stage for educating on a healthy lifestyle and correcting the habits that may have been acquired in childhood. Smartphone applications (apps) can provide a useful alternative to overweight and obesity prevention measures.
The objective of this study was to evaluate, through a randomized controlled clinical trial, the effect of an intervention based on a mobile health application (m-Health) on improving the degree of sport and nutrition knowledge, eating habits, and level of physical activity of adolescents.
The sample consists of 305 adolescents, 154 in the intervention group and 151 in the control group that are evaluated at the beginning and 6 months later regarding sociodemographic, eating habits, food knowledge, level of physical activity, body mass index, and waist circumference. The educational intervention was carried out using an m-Health tool, a mobile phone application. The outcomes were changes in the mentioned variables to a six-month follow-up between the two groups.
Detailed description
Design: A randomized parallel-group, controlled clinical trial was performed on adolescents from public secondary schools in the province of Cadiz, Spain.
Randomization and Blinding: The randomization and allocation to each group (1:1, intervention, and usual care) are based on computer-generated random numbers stratified in the three courses of secondary education. The researchers responsible for the study do not participate in the allocation of the participants. Due to the kind of intervention, blinding is not possible when the participants are allocated to groups. To minimize any bias, objective clinical variables are measured during the evaluation visit and the analyses are performed by blinded researchers.
Study Sample: The estimated sample size to detect a mean difference of at least one point in the level of healthy eating habits, measured by the KidMed questionnaire, with a standard deviation of the values in the questionnaire known from previous studies of 2.5 points, a level of confidence of 95% and statistical power of 90%, it was 126 participants in each group, intervention, and control. Assuming a 20% loss to follow-up, 305 participants were recruited, 154 in the intervention group and 151 in the control group.
Recruitment: All participants, in the intervention and control groups, received an Intervention on healthy habits consisting of four sessions developed by a nurse over two months. Adolescents who voluntarily decided to participate in the mobile Health educational intervention were recruited by a nurse. Both the adolescents and their parents signed the informed consent.
Intervention: The nurse installs the application on the mobile phone of the participants in the intervention group. It is a friendly, easy-to-use application for smartphones and tablets that favors the process of learning while playing.
Application Contents: Through the application, the adolescent participates in five activities: food, exercises, tests, learning more, and games that are different from each other but interconnected and that allow progress to be seen. The application "Care your habits" has educational materials on nutrition and physical activity. The participant records the food eaten and the physical activity performed, in addition to answering health questionnaires.
Technical Data of the Application:
The application has been developed for Android mobiles with versions between API 16 and API 28, which guarantees user compatibility. This app uses Firebase, a cloud platform that enables certain features, such as a secure login for app users. The application uses an initial Activity, which is responsible for managing the Login. The application is structured in different Fragments. Each of these Fragments is made up of a layout that is the graphical interface that the user sees and a class in the Java programming language that is the part in charge of processing the user's interaction with the interface and performing the appropriate action.
The app needs a server that manages interactions with the database where the data that users provide voluntarily from the app itself is stored. The part of the server that supports and complements the Android application is made up of a RESTful API developed in the NodeJS programming language. This server communicates with Firebase in order to verify the identity of the user who is providing data at all times, so that a user could not falsify another user's data.
All of this information is persistently stored in a NoSQL database, specifically a MongoDB database. The information provided by users is encrypted to prevent data theft.
Ethical Considerations: The study was conducted in agreement with the guidelines and protocols established in the Helsinki Declaration as revised in Fortaleza (Brazil) in October 2013, and complies with Law 14/2007 on Biomedical Research and with European Data Protection Regulations. The Biomedical Research Ethics Committee of Cádiz, Andalusian, approved the project with the reference: 11_02_2019. The informed written consent of all the participants and their parents was requested. The application guarantees security measures regarding the current General Data Protection Regulations in Europe. It also includes data encryption mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Mobile health applicationMobile application |
| Control group | No intervention | –Usual education |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Adolescents who were studying the 1st to 3rd grades of secondary education in public institutes
- Have a smartphone or tablet with an Android operating system and internet access
Key exclusion criteria (2 listed)
- Adolescents with barriers that prevented them from understanding the characteristics of the study: Comprehension, visual or auditory problems
- Adolescents with disease or treatment that affect the variables studied (diagnosed diseases that affect body weight such as liver or kidney disease or regular treatment with drugs such as corticosteroids)
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 health applicationHealth intervention through a smartphone application that favors the process of learning | Device | Intervention group |
Primary outcome
Eating habits
Time frame: 6 months
KidMed: A 16-item Questionnaire of Mediterranean diet adherence (unit of measure: points. Each item is scored 0 or 1. The total Mediterranean diet score ranges from 0 to 12 points. The higher the score, the higher the degree of adherence to the Mediterranean Diet).
Nutrition knowledge
Time frame: 6 months
General and Sport Nutrition knowledge Questionnaire: A questionnaire with 62 items (unit of measure: points. The higher the score, the higher the knowledge level)
Level of physical activity
Time frame: 6 months
Physical Activity Questionnaire for adolescents (PAQ-A) (The overall result of the test is a score from 1 to 5 points that allows to establish a graduation in the level of physical activity made by each adolescent. Do higher values represent a better outcome)
2 secondary outcomes
Body mass index
Time frame: 6 months
Waist circumference
Time frame: 6 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 15 Apr 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.
M J Santi, MD principal investigator
University of Cádiz
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 health application in people with Adolescent Obesity, run by University of Cadiz 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 2 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: finished, as of the sponsor's last update on 15 Apr 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?
Eating habits (time frame: 6 months). The study lists 3 primary outcomes in all. 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 15 Apr 2022.