TeenPower: e-Empowering Teenagers to Prevent Obesity (TeenPower)
Primary Purpose
Adolescent Obesity, Empowerment, ICT
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Structured school based intervention
mobile app usage
Sponsored by
About this trial
This is an interventional prevention trial for Adolescent Obesity
Eligibility Criteria
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
Sites / Locations
- Instituto Politécnico de Leiria
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Experimental Group A
Experimental Group B
Control Group
Arm Description
Structured school based intervention + mobile app usage
mobile app usage
Structured school based intervention
Outcomes
Primary Outcome Measures
Change from baseline BMI at 3 months
Body Mass Index
Change from baseline Physical activity at 3 months
Questionnaire "Quantification de l'Activité Physique en Altitude Chez les Enfants"
Change from baseline Nutrition at 3 months
Questionnaire on adolescent food choices
Change from baseline Adolescent Lifestyle at 3 months
Adolescent Lifestyle Profile Questionnaire
App usability
usability questionnaire
User experience
User experience questionnaire
Secondary Outcome Measures
Full Information
NCT ID
NCT03516097
First Posted
April 14, 2018
Last Updated
February 13, 2020
Sponsor
Instituto Politécnico de Leiria
Collaborators
Instituto Politécnico de Castelo Branco, Instituto Politécnico de Santarém, Município de Leiria
1. Study Identification
Unique Protocol Identification Number
NCT03516097
Brief Title
TeenPower: e-Empowering Teenagers to Prevent Obesity
Acronym
TeenPower
Official Title
TeenPower: e-Empowering Teenagers to Prevent Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
February 28, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Politécnico de Leiria
Collaborators
Instituto Politécnico de Castelo Branco, Instituto Politécnico de Santarém, Município de Leiria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity, Empowerment, ICT
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group A
Arm Type
Experimental
Arm Description
Structured school based intervention + mobile app usage
Arm Title
Experimental Group B
Arm Type
Experimental
Arm Description
mobile app usage
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Structured school based intervention
Intervention Type
Behavioral
Intervention Name(s)
Structured school based intervention
Intervention Description
Intervention includes behavioral, nutritional and physical activity counselling (online and face-to-face psycho-educative sessions).
Intervention Type
Device
Intervention Name(s)
mobile app usage
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from baseline BMI at 3 months
Description
Body Mass Index
Time Frame
Month 3
Title
Change from baseline Physical activity at 3 months
Description
Questionnaire "Quantification de l'Activité Physique en Altitude Chez les Enfants"
Time Frame
Month 3
Title
Change from baseline Nutrition at 3 months
Description
Questionnaire on adolescent food choices
Time Frame
Month 3
Title
Change from baseline Adolescent Lifestyle at 3 months
Description
Adolescent Lifestyle Profile Questionnaire
Time Frame
Month 3
Title
App usability
Description
usability questionnaire
Time Frame
Month 3
Title
User experience
Description
User experience questionnaire
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Instituto Politécnico de Leiria
City
Leiria
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
TeenPower: e-Empowering Teenagers to Prevent Obesity
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