NCT01904474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

July 9, 2013

Last Update Submit

November 16, 2015

Conditions

Obesity

Keywords

obesityoverweighttechnologyinternetinterventionadolescents

Outcome Measures

Primary Outcomes (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.

    24 weeks

Secondary Outcomes (7)

  • Change in physical activity

    24 weeks

  • Change in sedentary lifestyle

    24 weeks

  • Change in body image

    24 weeks

  • Next.Step Usability

    24 weeks

  • Change in weight specific quality of life

    24 weeks

  • +2 more secondary outcomes

Study Arms (2)

Next.Step

EXPERIMENTAL

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

Standard protocol

ACTIVE COMPARATOR

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

Interventions

Next.Step - e-therapeutic intervention programOTHER
Next.Step
Standard treatment protocolOTHER
Standard protocol

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Politécnico de Leiria

Leiria, 2411-901, Portugal

Location

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

Location

Related Publications (11)

  • 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.

    BACKGROUND

  • Baulch J, Chester A, Brennan L. Treatment Alternatives for Overweight and Obesity: The Role of Online Interventions. Behaviour Change 25(1): 1-14, 2008.

    BACKGROUND

  • Cottrell S. E-therapy: the future? Healthcare Counselling & Psychotherapy Journal 5(1): 18-21, 2005.

    BACKGROUND

  • Direção-Geral da Saúde. Programa Nacional de Combate à Obesidade. Circular Normativa nº 03/DGCG de 17/03/2005.

    BACKGROUND

  • 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).

    BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    PMID: 19665096BACKGROUND

  • Organization for Economic Cooperation and Development. Improving health sector efficiency - The role of information and communication technologies. Paris: OECD Health Policy Studie, 2010.

    BACKGROUND

  • Pender N, Murdaugh C, Parsons M. Health Promotion in Nursing Practice (6th ed.). Upper Saddle River, NJ: Pearson/Prentice-Hall.

    BACKGROUND

  • 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.

    PMID: 26966545DERIVED

  • 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.

    PMID: 25772743DERIVED

MeSH Terms

Conditions

ObesityOverweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pedro M Sousa, Msc

    Instituto Politécnico de Leiria

    STUDY CHAIR

  • Helena R Fonseca, PhD

    Hospital de Santa Maria, Portugal

    PRINCIPAL INVESTIGATOR

  • Pedro J Gaspar, PhD

    Instituto Politécnico de Leiria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 22, 2013

Study Start

April 1, 2013

Primary Completion

January 1, 2015

Study Completion

August 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

PT(2)