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Clinical Trials/NCT01904474
NCT01904474
Completed
Not Applicable

Internet Based Intervention Program for Obese Adolescents and Their Families(NEXT.STEP)

Hospital de Santa Maria, Portugal2 sites in 1 country116 target enrollmentApril 2013
ConditionsObesity

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
Hospital de Santa Maria, Portugal
Enrollment
116
Locations
2
Primary Endpoint
Change in Body mass index percentile
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study aims to:

I. Determine the e-therapeutic intervention program effectiveness compared with the standard treatment protocol, on both the behavioural change (treatment adherence and promotion of healthy lifestyles) and health impact (weight control and quality of life), based on a population of adolescents followed at Paediatric Obesity Clinic (POC) of Hospital de Santa Maria (HSM), Lisbon (Portugal).

II. Evaluate the health profile, treatment adherence, lifestyle and impact of weight on quality of life of this population.

III. Test the usability of an e-therapeutic platform for obese adolescents and their families.

Detailed Description

Information and Communications Technology (ICT) have been identified as important tools, allowing for health gains and reducing costs. They have been associated with positive results in terms of efficiency, effectiveness, equity, accessibility and quality of the provided care/services (Alcañiz et al., 2009; Baulch et al., 2008; Cottrell, 2005; Grohol, 1999). The existence of accurate, reliable, structured and relevant information, available when and where is needed, enables professionals and consumers to make informed and timely decisions (High Commissioner for Health, 2010; Organization for Economic Cooperation and Development, 2010). This project was designed according to the national guidelines (Direção-Geral da Saúde, 2005), and has the potential to become a relevant educational and intervention instrument. Its content may be adapted to the needs and expectations of target groups. Strategies as problem solving reinforced by the e-therapeutic programme may enable participants to overcome barriers to adherence and thereby enhance treatment-induced weight losses (Murawski et al., 2009). Moreover, this project will allow to: a) Obtain relevant information about patients and their progress, enabling health professionals to interpret the inputs and send feedback in real time, b) Tailor therapeutic strategies to individual responses, c) Monitor individual progress. This study is designed as a randomized clinical trial. The experimental group will follow the standard treatment protocol and, additionally, receive free access to the e-therapeutic platform (Next.Step) for 24 weeks. The control group participants will follow the standard treatment protocol and join a waiting list for entering the Next.Step. Based on the literature review and on the contribution of the Nola Pender's Health Promotion reference model (Pender et al., 2010), investigators will look for empirical evidence for the general investigation hypothesis: treatment adherence, healthy lifestyles, quality of life and weight control of obese adolescents are positively influenced by this intervention program.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
August 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital de Santa Maria, Portugal
Responsible Party
Principal Investigator
Principal Investigator

Pedro Sousa

Dr.

Instituto Politécnico de Leiria

Eligibility Criteria

Inclusion Criteria

  • patients from POC/HSM
  • aged between 12 and 18 years
  • BMI percentile ≥ 95th
  • internet access at least once a week

Exclusion Criteria

  • presence of severe psychopathology
  • inability to communicate in writing
  • pregnancy
  • having been proposed for bariatric surgery

Outcomes

Primary Outcomes

Change in Body mass index percentile

Time Frame: 24 weeks

Change in BMI percentile from baseline to 24 weeks. Height and weight will be used to calculate BMI percentile, adjusted for age and gender.

Secondary Outcomes

  • Change in physical activity(24 weeks)
  • Change in adherence to weight control(24 weeks)
  • Next.Step Usability(24 weeks)
  • Change in sedentary lifestyle(24 weeks)
  • Change in body image(24 weeks)
  • Change in weight specific quality of life(24 weeks)
  • Change in Lifestyle Profile(24 weeks)

Study Sites (2)

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