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E-therapeutic Program for Obese Adolescents

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ClinicalTrials.gov Identifier: NCT01904474
Recruitment Status : Completed
First Posted : July 22, 2013
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Instituto Politécnico de Leiria
Information provided by (Responsible Party):
Pedro Sousa, Instituto Politécnico de Leiria

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.


Condition or disease Intervention/treatment Phase
Obesity Other: Next.Step - e-therapeutic intervention program Other: Standard treatment protocol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Internet Based Intervention Program for Obese Adolescents and Their Families(NEXT.STEP)
Study Start Date : April 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
Experimental: 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.

Other: Next.Step - e-therapeutic intervention program
Active Comparator: 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.
Other: Standard treatment protocol



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in physical activity [ Time Frame: 24 weeks ]
    Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week

  2. Change in sedentary lifestyle [ Time Frame: 24 weeks ]
    Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week of screen time

  3. Change in body image [ Time Frame: 24 weeks ]
    Change in body image silhouette perception from baseline to 24 weeks

  4. Next.Step Usability [ Time Frame: 24 weeks ]
    Perception of usability of the Next.Step platform measure with a self-reported instrument (NSUQ - Next.Step Usability Questionnaire)

  5. Change in weight specific quality of life [ Time Frame: 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)

  6. Change in adherence to weight control [ Time Frame: 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)

  7. Change in Lifestyle Profile [ Time Frame: 24 weeks ]
    Change in Lifestyle Profile from baseline to 24 weeks, evaluated with a self-report instrument (ALP - Adolescent Lifestyle Profile).



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01904474


Locations
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Portugal
Instituto Politécnico de Leiria
Leiria, Portugal, 2411-901
Hospital de Santa Maria
Lisboa, Portugal, 1649-035
Sponsors and Collaborators
Hospital de Santa Maria, Portugal
Instituto Politécnico de Leiria
Investigators
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Study Chair: Pedro M Sousa, Msc Instituto Politécnico de Leiria
Principal Investigator: Helena R Fonseca, PhD Hospital de Santa Maria, Portugal
Study Chair: Pedro J Gaspar, PhD Instituto Politécnico de Leiria
Publications:
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).
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Pedro Sousa, Dr., Instituto Politécnico de Leiria
ClinicalTrials.gov Identifier: NCT01904474    
Other Study ID Numbers: PTDC/DTP-PIC/0769/2012
First Posted: July 22, 2013    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Pedro Sousa, Instituto Politécnico de Leiria:
obesity
overweight
technology
internet
intervention
adolescents
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms