NCT03516097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

April 14, 2018

Last Update Submit

February 13, 2020

Conditions

Adolescent ObesityEmpowermentICT

Outcome Measures

Primary Outcomes (6)

  • Change from baseline BMI at 3 months

    Body Mass Index

    Month 3

  • Change from baseline Physical activity at 3 months

    Questionnaire "Quantification de l'Activité Physique en Altitude Chez les Enfants"

    Month 3

  • Change from baseline Nutrition at 3 months

    Questionnaire on adolescent food choices

    Month 3

  • Change from baseline Adolescent Lifestyle at 3 months

    Adolescent Lifestyle Profile Questionnaire

    Month 3

  • App usability

    usability questionnaire

    Month 3

  • User experience

    User experience questionnaire

    Month 3

Study Arms (3)

Experimental Group A

EXPERIMENTAL

Structured school based intervention + mobile app usage

Behavioral: Structured school based interventionDevice: mobile app usage

Experimental Group B

EXPERIMENTAL

mobile app usage

Device: mobile app usage

Control Group

ACTIVE COMPARATOR

Structured school based intervention

Behavioral: Structured school based intervention

Interventions

Structured school based interventionBEHAVIORAL

Intervention includes behavioral, nutritional and physical activity counselling (online and face-to-face psycho-educative sessions).

Control GroupExperimental Group A
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).

Experimental Group AExperimental Group B

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • school groups of Leiria, Santarém and Castelo Branco, aged between 12 and 16, with easy access to internet and smartphone/tablet

You may not qualify if:

  • language or cognitive limitations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Politécnico de Leiria

Leiria, Portugal

Location

MeSH Terms

Conditions

Pediatric ObesityEmpowerment

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 14, 2018

First Posted

May 4, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2018

Study Completion

February 28, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Locations

PT(1)