E-therapeutic Program for Obese Adolescents

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904474
• Other study ID #: PTDC/DTP-PIC/0769/2012
• Status: Completed
• Phase: N/A
• First received: July 9, 2013
• Last updated: November 16, 2015
• Start date: April 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Hospital de Santa Maria, Portugal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Next.Step - e-therapeutic intervention program

• Standard treatment protocol

Locations

Country	Name	City	State
Portugal	Instituto Politécnico de Leiria	Leiria
Portugal	Hospital de Santa Maria	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Santa Maria, Portugal	Instituto Politécnico de Leiria

Country where clinical trial is conducted

Portugal, 

References & Publications (9)

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. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body mass index percentile	Change in BMI percentile from baseline to 24 weeks. Height and weight will be used to calculate BMI percentile, adjusted for age and gender.	24 weeks	No
Secondary	Change in physical activity	Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week	24 weeks	No
Secondary	Change in sedentary lifestyle	Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week of screen time	24 weeks	No
Secondary	Change in body image	Change in body image silhouette perception from baseline to 24 weeks	24 weeks	No
Secondary	Next.Step Usability	Perception of usability of the Next.Step platform measure with a self-reported instrument (NSUQ - Next.Step Usability Questionnaire)	24 weeks	No
Secondary	Change in weight specific quality of life	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)	24 weeks	No
Secondary	Change in adherence to weight control	Change in adherence to weight control from baseline to 24 weeks, evaluated with a self-report instrument (AWCQ - Adherence to Weight Control Questionnaire)	24 weeks	No
Secondary	Change in Lifestyle Profile	Change in Lifestyle Profile from baseline to 24 weeks, evaluated with a self-report instrument (ALP - Adolescent Lifestyle Profile).	24 weeks	No