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ObesityNCT01904474

E-therapeutic Program for Obese Adolescents

A study testing Next.Step - e-therapeutic intervention program and Standard treatment protocol in people with Obesity, run by Hospital de Santa Maria, Portugal at 2 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Obesity
What is being tested?
Next.Step - e-therapeutic intervention program and Standard treatment protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
2 sitesPortugal
Study dates
Apr 2013to Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • patients from POC/HSM
  • aged between 12 and 18 years
  • BMI percentile ≥ 95th
  • internet access at least once a week

Who cannot join

  • presence of severe psychopathology
  • inability to communicate in writing
  • pregnancy
  • having been proposed for bariatric surgery

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

  • Instituto Politécnico de Leiria

    Leiria, 2411-901

  • Hospital de Santa Maria

    Lisbon, 1649-035

Other trials in Portugal

About this study

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

This study aims to:

  1. 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.

Read the 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.

Conditions
Obesity
Being tested
Next.Step - e-therapeutic intervention program, Standard treatment protocol
Keywords
obesity, overweight, technology, internet, intervention, adolescents
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Next.Step - e-therapeutic intervention programOther

  • Standard treatment protocolOther

Study groups in NCT01904474
Study groupRoleWhat they receive
Next.StepExperimentalExperimental 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.
Receives: Other: Next.Step - e-therapeutic intervention program
Standard protocolActive comparatorThe 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.
Receives: Other: Standard treatment protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 weeks

Secondary outcomes (7)

  1. Change in physical activity

    Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week

    Measured: 24 weeks

  2. Change in sedentary lifestyle

    Change in physical activity from baseline to 24 weeks, measure in self-reported hours/week of screen time

    Measured: 24 weeks

  3. Change in body image

    Change in body image silhouette perception from baseline to 24 weeks

    Measured: 24 weeks

  4. Next.Step Usability

    Perception of usability of the Next.Step platform measure with a self-reported instrument (NSUQ - Next.Step Usability Questionnaire)

    Measured: 24 weeks

  5. 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)

    Measured: 24 weeks

  6. 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)

    Measured: 24 weeks

  7. Change in Lifestyle Profile

    Change in Lifestyle Profile from baseline to 24 weeks, evaluated with a self-report instrument (ALP - Adolescent Lifestyle Profile).

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionJan 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01904474
Sponsor's protocol ID
PTDC/DTP-PIC/0769/2012
Status last verified
Nov 2015
First submitted
9 Jul 2013
Last updated
17 Nov 2015
Results posted
No

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).

  • 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.

    PubMed 19665096

  • 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.

    PubMed 26966545

  • 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.

    PubMed 25772743

Questions about this trial

What is this clinical trial studying?

A study testing Next.Step - e-therapeutic intervention program and Standard treatment protocol in people with Obesity, run by Hospital de Santa Maria, Portugal at 2 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Body mass index percentile (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904474, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.

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