E-therapeutic Program for Obese Adolescents

Not Applicable

Completed

• Conditions: Obesity

• Registration Number: NCT01904474
• Lead Sponsor: Hospital de Santa Maria, Portugal

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-07-09
• Study First Submitted QC: 2013-07-17
• Study First Posted: 2013-07-22
• Primary Completion: 2015-01
• Study Completion: 2015-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Body mass index percentile	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 Outcome Measures

Name	Time	Method
Change in physical activity	24 weeks	Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week
Change in adherence to weight control	24 weeks	Change in adherence to weight control from baseline to 24 weeks, evaluated with a self-report instrument (AWCQ - Adherence to Weight Control Questionnaire)
Next.Step Usability	24 weeks	Perception of usability of the Next.Step platform measure with a self-reported instrument (NSUQ - Next.Step Usability Questionnaire)
Change in sedentary lifestyle	24 weeks	Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week of screen time
Change in body image	24 weeks	Change in body image silhouette perception from baseline to 24 weeks
Change in weight specific quality of life	24 weeks	Change in weight specific quality of life from baseline to 24 weeks, evaluated with a self-report instrument (IWQOL - Impact of Weight on Quality of Life)
Change in Lifestyle Profile	24 weeks	Change in Lifestyle Profile from baseline to 24 weeks, evaluated with a self-report instrument (ALP - Adolescent Lifestyle Profile).

Trial Locations

Locations (2)

Instituto Politécnico de Leiria; 🇵🇹 Leiria, Portugal

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal