- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03516097
TeenPower: e-Empowering Teenagers to Prevent Obesity (TeenPower)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leiria, Portugal
- Instituto Politécnico de Leiria
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- school groups of Leiria, Santarém and Castelo Branco, aged between 12 and 16, with easy access to internet and smartphone/tablet
Exclusion Criteria:
- language or cognitive limitations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental Group A
Structured school based intervention + mobile app usage
|
Intervention includes behavioral, nutritional and physical activity counselling (online and face-to-face psycho-educative sessions).
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).
|
EXPERIMENTAL: Experimental Group B
mobile app usage
|
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).
|
ACTIVE_COMPARATOR: Control Group
Structured school based intervention
|
Intervention includes behavioral, nutritional and physical activity counselling (online and face-to-face psycho-educative sessions).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline BMI at 3 months
Time Frame: Month 3
|
Body Mass Index
|
Month 3
|
Change from baseline Physical activity at 3 months
Time Frame: Month 3
|
Questionnaire "Quantification de l'Activité Physique en Altitude Chez les Enfants"
|
Month 3
|
Change from baseline Nutrition at 3 months
Time Frame: Month 3
|
Questionnaire on adolescent food choices
|
Month 3
|
Change from baseline Adolescent Lifestyle at 3 months
Time Frame: Month 3
|
Adolescent Lifestyle Profile Questionnaire
|
Month 3
|
App usability
Time Frame: Month 3
|
usability questionnaire
|
Month 3
|
User experience
Time Frame: Month 3
|
User experience questionnaire
|
Month 3
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- POCI-01-0145-FEDER-23557
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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