Treatment of Pediatric Obesity (TOP) - A Multidisciplinary Approach Involving Adolescents and Their Peers (TOP)

July 19, 2017 updated by: Antonio Palmeira, Grupo Lusófona

Tratamento da Obesidade Pedi ́Atrica (TOP) - Uma Abordagem Multidisciplinar Envolvendo Pais e Pares

The purpose of this study is to analyse if a multidisciplinary approach including peers is effective in the treatment of obesity in adolescence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One in every 3 Portuguese adolescents is overweight (14% obese) (ONOCOP, 2009). Several institutions state that prevention is of upmost importance to deal with this epidemic (Council on Sports Medicine and Fitness; Council on School Health, 2006, August et al, 2008, Kohn et al, 2006), but public health stakeholders should also increase their efforts to treat those who already have excessive weight (Oude Luttikhuis et al, 2009). Several facts support this need, namely that obesity in adolescence: a) has a significant impact on both physical and psychosocial health (Lobstein et al, 2004); b) is an independent risk factor for adult obesity (Singh et al, 2008); c) is an independent risk factor for all cause mortality in adulthood - a more powerful predictor than being overweight in adult (Must et al, 1992); and d) is a major threat to the steady rise in life expectancy that occurred during the past two centuries (Olshansky et al, 2005).

Albeit this cumulative knowledge, treatment options remain elusive. A Cochrane review (Oude Luttikhuis et al, 2009) concluded that combined behavioral lifestyle interventions, when compared to standard care or self-help, provide significant and clinically meaningful reductions on weight in adolescents; and that the interventions should consider psychosocial determinants for behavior change and strategies to improve clinician-family interaction, in order to improve the desired outcomes.

The team of the TOP project has been working in this subject since 2004: the consult for obese adolescents of the Hospital de Santa Maria (HSM), a result of the collaboration between the two proponent Institutions. This has allowed the inclusion of exercise specialists in the obese adolescent' consult of the HSM, leading to an unusual (Fonseca et al, 2008), but surely necessary (Barlow et al, 2007), multidisciplinary program where, in the same Unit, adolescents are evaluated and receive medical, dietary and physical activity counselling. In compliance with the latest recommendations (Oude Luttikhuis et al, 2009), we use behavior change techniques directed not only to the adolescent but also to their parents, using the self-determination theory (SDT) rationale and motivational interviewing techniques (Teixeira et al, 2012), a treatment protocol that has been recognized by the Society for Adolescent Medicine (Fonseca et al, 2010).

Based on our previous experience and on recent literature that claims for the inclusion of peers as co-adjuvant on the weight management tasks, we hypothesize that: a) a larger and more frequent contact with the treatment staff; and b) the inclusion of peers as co-adjuvant on the weight management tasks in the TOP is necessary. Indeed, literature shows that adolescent' health related behaviors are associated with peer behaviors, in what Dishion named Social Contagion (Dishion & Dodge, 2005). Additionally, we think that regular physical activity (PA) and interactive educative sessions can provide the background to promote these two factors (Fonseca et al, 2012).

Therefore, the primary objective of this project is to develop, implement, and evaluate a treatment for adolescent obesity, which will use PA and interactive sessions to promote weight management skills, through the increase of contact time between the adolescent, parents, peers and treatment staff.

The primary outcomes will be body composition related variables, PA and sedentary behaviors. We will also look for putative moderators and mediators, derived from the behavior change rationales followed in the project, which will help understand and predict how the program has influenced the outcomes.

This project holds unique characteristics which comply with the latest recommendations for the treatment of adolescent obesity, and others that we have not been able to find in the literature: a) the inclusion of peers explicitly on the treatment protocol; b) the clinical setting of the treatment, with "real-life" subjects; c) objective measurements of the outcomes; d) the long-term treatment; and e) a well established rational (SDT and experiential learning) for the behavior change and to analyze the causal relations between predictors and outcomes.

This research is expected to contribute with increased knowledge about treatment options for adolescent obesity, specifically about the potential role of the inclusion of peers and increased time of contact through PA and interactive sessions. We also expect to contribute in a significant and clinically meaningful way to the weight management of the intervened adolescents. And, as HSM is a central hospital and a part of a medical university, the accumulated knowledge of the project will certainly be efficiently widespread to several other hospitals and obesity centers.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisboa, Portugal, 1649-035
        • Consulta de Obesidade na Adolescência, Hospital Santa Maria
      • Lisboa, Portugal, 1749-024
        • Universidade Lusófona Humanidades e Tecnologias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese adolescents with BMI greater than or equal to the 95th percentile
  • Aged between 14 and 17
  • Caucasian
  • Agree to the commitment.

Exclusion Criteria:

  • Adolescents with serious illnesses
  • Other factors preventing the engagement in regular PA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peer support

The intervention will be similar with the exception that in the experimental group during the interventions (Interactive Sessions, Physical activity sessions and holiday camps), the presence of peers is predominant, indispensable and motivational in the context and the dynamics of development of activities.

A team composed by a paediatrician and five exercise physiologists will conduct the delivery of the intervention. They all have previous training in adolescent obesity, resulting from their involvement in the adolescent obesity consult at the Hospital of Santa Maria.
Behavioral: Peer support
Active Comparator: Regular treatment

The intervention will be similar with the exception that in the experimental group during the interventions (IS, PA sessions and holiday camps), the presence of peers is predominant, indispensible and motivational in the context and the dynamics of development of activities.

A team composed by a paediatrician and five exercise physiologists will conduct the delivery of the intervention. They all have previous training in adolescent obesity, resulting from their involvement in the adolescent obesity consult at the Hospital of Santa Maria.
Behavioral: Regular treatment
The participants in this arm will receive the regular obesity treatment provided by the hospital and university (interactive sessions and physical activity).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI z-score
Time Frame: Baseline, 4, 8 and 12 mo
BMI z-score will be calculated through height and weight measured with standardised procedures
Baseline, 4, 8 and 12 mo
Change in % Fat Mass
Time Frame: Baseline, 6 and 12 mo
The % of Fat Mass will be measured through dual energy x-ray absorptiometry.
Baseline, 6 and 12 mo
Change in the Physical Activity Level
Time Frame: Baseline, 4, 8 and 12 mo
The Physical Activity Level will be assessed by actigraphy (Actigraph GT3x).
Baseline, 4, 8 and 12 mo
Change in Sedentary behavior
Time Frame: Baseline, 4, 8 and 12 mo
The sedentary behavior will be assessed by actigraphy (Actigraph GT3x) and by questionnaires (ASAQ)
Baseline, 4, 8 and 12 mo

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in psychosocial health
Time Frame: Baseline, 4, 8 and 12 mo
Quality of life, well-being and self-regulation variables will be measured by validated psychometric questionnaires.
Baseline, 4, 8 and 12 mo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Lusófona

Collaborators

University of Lisbon
Fundação para a Ciência e a Tecnologia

Investigators

  • Principal Investigator: Helena R Fonseca, MD, PhD, Faculty of Medicine, University of Lisbon
  • Principal Investigator: Antonio L Palmeira, PhD, U. Lusófona Humanidades e Tecnologias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 26, 2013

First Posted (Estimate)

December 31, 2013

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 19, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTDC/DES/113591/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Peer support

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tunisia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe