Adolescent ObesityTeenPowerNCT03516097
TeenPower: e-Empowering Teenagers to Prevent Obesity
A study testing Structured school based intervention and mobile app usage in people with Adolescent Obesity and Empowerment, run by Instituto Politécnico de Leiria at 1 site in Portugal.
Trial summary
Transdisciplinary practice-based action research project that aims to develop innovative cognitive-behavioral interventions to empower adolescents, through increased and interactive contact between adolescent and multidisciplinary healthcare team. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Adolescent Obesity, Empowerment, ICT
- What is being tested?
- Structured school based intervention and mobile app usage
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2018to 28 Feb 2019
- 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
- No healthy volunteers
- Child
Who may be able to join
- school groups of Leiria, Santarém and Castelo Branco, aged between 12 and 16, with easy access to internet and smartphone/tablet
Who cannot join
- language or cognitive limitations
Trial locations and contacts
1 site in 1 country.
About this study
Transdisciplinary practice-based action research project that aims to develop innovative cognitive-behavioral interventions to empower adolescents, through increased and interactive contact between adolescent and multidisciplinary healthcare team. Project born from the discussion with trans-territorial stakeholders (health professionals and school communities), in the absence of an integrated, creative and dynamic strategy of overweight prevention and promotion of salutogenic behaviors in adolescents.
The polytechnics of Leiria, Santarém and Castelo Branco are co-promotors of this project, as well as Município de Leiria (City Council), key partners in the development and implementation of the intervention program. It is expected the partnership with ARS-Centro.
The main goal is the development, implementation and evaluation of a program for the promotion of healthy behaviors and prevention of obesity in adolescence, based on e-therapy and sustained by the case management methodology.
Read the detailed description
Transdisciplinary practice-based action research project that aims to develop innovative interventions to promote healthy behaviors. Project called from a territorial issue, identified and discussed with local stakeholders (health professionals and school community), in the absence of an integrated, creative and dynamic strategy of overweight prevention and promotion of salutogenic behaviors in adolescents.
Adolescent obesity has reached epidemic proportions, being urgent to find effective prevention strategies and adequate resources that induce change at the individual, family and community level. The core components of classic prevention programs have been unable to obtain the desired adherence. The solution may involve a more extensive and frequent contact with the healthcare team and the use of alternative communication channels and interacting/dynamic technologies with adolescents.
Given the research team's experience in developing innovative products and healthcare technological solutions, this need was faced as an opportunity to network and explore synergies between territorial partners. The polytechnics of Leiria (IPL), Santarém (IPS) and Castelo Branco (IPCB) are co-promotors of this project, as well as the Município de Leiria (City Council). It is also expected the partnership with the local primary healthcare stakeholders (Administração Regional de Saúde do Centro: ARS-C), key partners in the development phase and in the implementation of the intervention program. An agile product development process will be adopted, an iterative and incremental approach for planning and implementing, in an intense and permanent dialogue with healthcare professionals, and adolescents throughout the platform and the mobile app development process.
The main goal is the development, implementation and evaluation of a program for the promotion of healthy behaviors and prevention of obesity in adolescence, based on e-therapy and sustained by the case management methodology. The project is directed to the cognitive-behavioral empowerment of adolescents, through increased and interactive contact between adolescents and multidisciplinary healthcare team. The use of Information and Communication Technologies (ICT) in the intervention can optimize resources and maximize impact, as a complement to conventional approaches, The project includes the development of three complementary studies: (S1) evaluation of adolescents' health status and cognitive-behavioral indicators, (S2) usability evaluation of the TeenPower platform and mobile app (S3) implementation and adherence evaluation to the TeenPower intervention program.
The positive evaluation of the intervention program will stimulate the inclusion of ICT in the promotion of salutogenic behaviors and overweight prevention, creating technological interfaces that will allow customizing the intervention parameters and facilitating the monitoring and tracking.
- Conditions
- Adolescent Obesity, Empowerment, ICT
- Being tested
- Structured school based intervention, mobile app usage
- Medical subject headings
- Pediatric Obesity, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured school based interventionBehavioural
Intervention includes behavioral, nutritional and physical activity counselling (online and face-to-face psycho-educative sessions).
mobile app usageDevice
The e-therapeutic platform and mobile app (TeenPower) includes educational resources, self-monitoring, social support, interactive training modules and motivational tools. In addition to the case manager, the program will also have the direct support of an interdisciplinary team (nurse, nutritionist, exercise physiologist, psychologist among others).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group A | Experimental | Structured school based intervention + mobile app usage Receives: Behavioral: Structured school based intervention; Device: mobile app usage |
| Experimental Group B | Experimental | mobile app usage Receives: Device: mobile app usage |
| Control Group | Active comparator | Structured school based intervention Receives: Behavioral: Structured school based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline BMI at 3 months
Body Mass Index
Measured: Month 3
Change from baseline Physical activity at 3 months
Questionnaire "Quantification de l'Activité Physique en Altitude Chez les Enfants"
Measured: Month 3
Change from baseline Nutrition at 3 months
Questionnaire on adolescent food choices
Measured: Month 3
Change from baseline Adolescent Lifestyle at 3 months
Adolescent Lifestyle Profile Questionnaire
Measured: Month 3
App usability
usability questionnaire
Measured: Month 3
User experience
User experience questionnaire
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2018
- Study completion28 Feb 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Politécnico de Leiria
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Politécnico de Castelo Branco, Polytechnic University of Santarém, Município de Leiria
- Responsible party
- Principal investigator, Pedro Sousa, Instituto Politécnico de Leiria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516097
- Sponsor's protocol ID
- POCI-01-0145-FEDER-23557
- Acronym
- TeenPower
- Status last verified
- Feb 2020
- First submitted
- 14 Apr 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TeenPower: e-Empowering Teenagers to Prevent Obesity
- ClinicalTrials.gov ID
- NCT03516097
- Acronym / sponsor ID
- TeenPower / POCI-01-0145-FEDER-23557
- Conditions
- Adolescent Obesity, Empowerment, ICT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Instituto Politécnico de LeiriaUniversity, hospital or other
- Collaborators
- Instituto Politécnico de Castelo Branco, Polytechnic University of Santarém, Município de Leiria
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 4 May 2018 (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.
Transdisciplinary practice-based action research project that aims to develop innovative cognitive-behavioral interventions to empower adolescents, through increased and interactive contact between adolescent and multidisciplinary healthcare team. Project born from the discussion with trans-territorial stakeholders (health professionals and school communities), in the absence of an integrated, creative and dynamic strategy of overweight prevention and promotion of salutogenic behaviors in adolescents.
The polytechnics of Leiria, Santarém and Castelo Branco are co-promotors of this project, as well as Município de Leiria (City Council), key partners in the development and implementation of the intervention program. It is expected the partnership with ARS-Centro.
The main goal is the development, implementation and evaluation of a program for the promotion of healthy behaviors and prevention of obesity in adolescence, based on e-therapy and sustained by the case management methodology.
Detailed description
Transdisciplinary practice-based action research project that aims to develop innovative interventions to promote healthy behaviors. Project called from a territorial issue, identified and discussed with local stakeholders (health professionals and school community), in the absence of an integrated, creative and dynamic strategy of overweight prevention and promotion of salutogenic behaviors in adolescents.
Adolescent obesity has reached epidemic proportions, being urgent to find effective prevention strategies and adequate resources that induce change at the individual, family and community level. The core components of classic prevention programs have been unable to obtain the desired adherence. The solution may involve a more extensive and frequent contact with the healthcare team and the use of alternative communication channels and interacting/dynamic technologies with adolescents.
Given the research team's experience in developing innovative products and healthcare technological solutions, this need was faced as an opportunity to network and explore synergies between territorial partners. The polytechnics of Leiria (IPL), Santarém (IPS) and Castelo Branco (IPCB) are co-promotors of this project, as well as the Município de Leiria (City Council). It is also expected the partnership with the local primary healthcare stakeholders (Administração Regional de Saúde do Centro: ARS-C), key partners in the development phase and in the implementation of the intervention program. An agile product development process will be adopted, an iterative and incremental approach for planning and implementing, in an intense and permanent dialogue with healthcare professionals, and adolescents throughout the platform and the mobile app development process.
The main goal is the development, implementation and evaluation of a program for the promotion of healthy behaviors and prevention of obesity in adolescence, based on e-therapy and sustained by the case management methodology. The project is directed to the cognitive-behavioral empowerment of adolescents, through increased and interactive contact between adolescents and multidisciplinary healthcare team. The use of Information and Communication Technologies (ICT) in the intervention can optimize resources and maximize impact, as a complement to conventional approaches, The project includes the development of three complementary studies: (S1) evaluation of adolescents' health status and cognitive-behavioral indicators, (S2) usability evaluation of the TeenPower platform and mobile app (S3) implementation and adherence evaluation to the TeenPower intervention program.
The positive evaluation of the intervention program will stimulate the inclusion of ICT in the promotion of salutogenic behaviors and overweight prevention, creating technological interfaces that will allow customizing the intervention parameters and facilitating the monitoring and tracking.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group A | Experimental | Behavioral: Structured school based intervention, Device: mobile app usageStructured school based intervention + mobile app usage |
| Experimental Group B | Experimental | Device: mobile app usagemobile app usage |
| Control Group | Active comparator | Behavioral: Structured school based interventionStructured school based intervention |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- school groups of Leiria, Santarém and Castelo Branco, aged between 12 and 16, with easy access to internet and smartphone/tablet
Key exclusion criteria (1 listed)
- language or cognitive limitations
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 |
|---|---|---|
| Structured school based interventionIntervention includes behavioral, nutritional and physical activity counselling (online and face-to-face psycho-educative sessions). | Behavioural | Control Group, Experimental Group A |
| mobile app usageThe e-therapeutic platform and mobile app (TeenPower) includes educational resources, self-monitoring, social support, interactive training modules and motivational tools. In addition to the case manager, the program will also have the direct support of an interdisciplinary team (nurse, nutritionist, exercise physiologist, psychologist among others). | Device | Experimental Group A, Experimental Group B |
Primary outcome
Change from baseline BMI at 3 months
Time frame: Month 3
Body Mass Index
Change from baseline Physical activity at 3 months
Time frame: Month 3
Questionnaire "Quantification de l'Activité Physique en Altitude Chez les Enfants"
Change from baseline Nutrition at 3 months
Time frame: Month 3
Questionnaire on adolescent food choices
Change from baseline Adolescent Lifestyle at 3 months
Time frame: Month 3
Adolescent Lifestyle Profile Questionnaire
App usability
Time frame: Month 3
usability questionnaire
User experience
Time frame: Month 3
User experience questionnaire
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 17 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured school based intervention and mobile app usage in people with Adolescent Obesity and Empowerment, run by Instituto Politécnico de Leiria at 1 site in Portugal.
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 1 inclusion and 1 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 17 Feb 2020. 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 Portugal. 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?
Change from baseline BMI at 3 months (time frame: Month 3). The study lists 6 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 17 Feb 2020.