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临床试验/NCT02024061
NCT02024061已完成不适用

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

Grupo Lusófona4 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
99
试验地点
4
主要终点
Change in the Physical Activity Level

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Peer support

Experimental

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.

干预措施: Peer support (Behavioral)

Regular treatment

Active Comparator

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.

干预措施: Regular treatment (Behavioral)

结局指标

主要结局

Change in the Physical Activity Level

时间窗: Baseline, 4, 8 and 12 mo

The Physical Activity Level will be assessed by actigraphy (Actigraph GT3x).

Change in % Fat Mass

时间窗: Baseline, 6 and 12 mo

The % of Fat Mass will be measured through dual energy x-ray absorptiometry.

Change in BMI z-score

时间窗: Baseline, 4, 8 and 12 mo

BMI z-score will be calculated through height and weight measured with standardised procedures

Change in Sedentary behavior

时间窗: Baseline, 4, 8 and 12 mo

The sedentary behavior will be assessed by actigraphy (Actigraph GT3x) and by questionnaires (ASAQ)

次要结局

  • Changes in psychosocial health(Baseline, 4, 8 and 12 mo)

研究者

发起方
Grupo Lusófona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Palmeira

Associate Professor

Grupo Lusófona

研究点 (4)

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