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E-therapeutic Program for Obese Adolescents

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01904474
Enrollment
116
Registered
2013-07-22
Start date
2013-04-30
Completion date
2015-08-31
Last updated
2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, overweight, technology, internet, intervention, adolescents

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.

Interventions

OTHERNext.Step - e-therapeutic intervention program

Sponsors

Instituto Politécnico de Leiria
CollaboratorOTHER
Hospital de Santa Maria, Portugal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Body mass index percentile24 weeksChange in BMI percentile from baseline to 24 weeks. Height and weight will be used to calculate BMI percentile, adjusted for age and gender.

Secondary

MeasureTime frameDescription
Change in body image24 weeksChange in body image silhouette perception from baseline to 24 weeks
Next.Step Usability24 weeksPerception of usability of the Next.Step platform measure with a self-reported instrument (NSUQ - Next.Step Usability Questionnaire)
Change in physical activity24 weeksChange in physical activity from baseline to 24 weeks, measure in self-reported hours/week
Change in sedentary lifestyle24 weeksChange in physical activity from baseline to 24 weeks, measure in self-reported hours/week of screen time
Change in adherence to weight control24 weeksChange 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 Profile24 weeksChange in Lifestyle Profile from baseline to 24 weeks, evaluated with a self-report instrument (ALP - Adolescent Lifestyle Profile).
Change in weight specific quality of life24 weeksChange 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)

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026