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
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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|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|
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
- 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.
- Change in physical activity [ Time Frame: 24 weeks ]Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week
- 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
- Change in body image [ Time Frame: 24 weeks ]Change in body image silhouette perception from baseline to 24 weeks
- 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)
- 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)
- 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)
- 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).
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
|Instituto Politécnico de Leiria|
|Leiria, Portugal, 2411-901|
|Hospital de Santa Maria|
|Lisboa, Portugal, 1649-035|
|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|