Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2013-04-30
2015-08-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Next.Step
Experimental group participants, in addition to the standard treatment program are invited to get restricted access to the e-therapeutic platform (Next.Step), which includes a diverse set of resources, such as: educational resources (videos, brochures, menus, weekly tips, access to other links), self-monitoring (food, weight and physical activity records), social support (chats, discussion forums and personalized messages), interactive training modules (self-assessment quizzes, making their own diets) and motivational tools (personal goals planning, treatment progression registry, positive reinforcement).
Intervention length will be 36 weeks (24 weeks of direct intervention with a follow-up of 12 weeks), being based on case management methodology.
Next.Step - e-therapeutic intervention program
Standard protocol
The control group will follow the POC/HSM standard treatment protocol, which includes a baseline evaluation session with a paediatrician for initial screening, followed by appointments with the nutritionist and exercise physiologist. The second set of appointments will take place one month after for adjustments. After this, the adolescent will have appointments at 3, 6, 9 and 12 months. These adolescents will join a waiting list and nine months (36 weeks) after having started the standard treatment, they will receive the personal codes for accessing Next.Step.
Standard treatment protocol
Interventions
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Next.Step - e-therapeutic intervention program
Standard treatment protocol
Eligibility Criteria
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Inclusion Criteria
* aged between 12 and 18 years
* BMI percentile ≥ 95th
* internet access at least once a week
Exclusion Criteria
* inability to communicate in writing
* pregnancy
* having been proposed for bariatric surgery
12 Years
18 Years
ALL
No
Sponsors
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Instituto Politécnico de Leiria
OTHER
Hospital de Santa Maria, Portugal
OTHER
Responsible Party
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Pedro Sousa
Dr.
Principal Investigators
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Pedro M Sousa, Msc
Role: STUDY_CHAIR
Instituto Politécnico de Leiria
Helena R Fonseca, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Santa Maria, Portugal
Pedro J Gaspar, PhD
Role: STUDY_CHAIR
Instituto Politécnico de Leiria
Locations
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Instituto Politécnico de Leiria
Leiria, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
Countries
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References
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Alcañiz M, Botella C, Baños R, Zaragoza I, Guixeres J. The Intelligent e-Therapy system: a new paradigm for telepsychology and cybertherapy. British Journal of Guidance & Counselling 37(3): 287-296, 2009.
Baulch J, Chester A, Brennan L. Treatment Alternatives for Overweight and Obesity: The Role of Online Interventions. Behaviour Change 25(1): 1-14, 2008.
Cottrell S. E-therapy: the future? Healthcare Counselling & Psychotherapy Journal 5(1): 18-21, 2005.
Direção-Geral da Saúde. Programa Nacional de Combate à Obesidade. Circular Normativa nº 03/DGCG de 17/03/2005.
Grohol JH. Best practices in e-therapy: Definition & Scope of e-therapy. 1999. Available at: www.psychcentral.com/best/best3.htm (accessed 12 Feb 2012).
High Commissioner for Health [Alto Comissariado da Saúde]. Plano Nacional de Saúde 2011-2016: Tecnologias de Informação e Comunicação, 2010. Available at: www.acs.min-saude.pt/pns2011-2016/files/2010/07/TIC4.pdf (accessed 12 Fev 2012).
Murawski ME, Milsom VA, Ross KM, Rickel KA, DeBraganza N, Gibbons LM, Perri MG. Problem solving, treatment adherence, and weight-loss outcome among women participating in lifestyle treatment for obesity. Eat Behav. 2009 Aug;10(3):146-51. doi: 10.1016/j.eatbeh.2009.03.005. Epub 2009 Mar 29.
Organization for Economic Cooperation and Development. Improving health sector efficiency - The role of information and communication technologies. Paris: OECD Health Policy Studie, 2010.
Pender N, Murdaugh C, Parsons M. Health Promotion in Nursing Practice (6th ed.). Upper Saddle River, NJ: Pearson/Prentice-Hall.
Fonseca H, Prioste A, Sousa P, Gaspar P, Machado Mdo C. Effectiveness analysis of an internet-based intervention for overweight adolescents: next steps for researchers and clinicians. BMC Obes. 2016 Mar 9;3:15. doi: 10.1186/s40608-016-0094-4. eCollection 2016.
Sousa P, Fonseca H, Gaspar P, Gaspar F. Controlled trial of an Internet-based intervention for overweight teens (Next.Step): effectiveness analysis. Eur J Pediatr. 2015 Sep;174(9):1143-57. doi: 10.1007/s00431-015-2502-z. Epub 2015 Mar 14.
Other Identifiers
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PTDC/DTP-PIC/0769/2012
Identifier Type: -
Identifier Source: org_study_id