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临床试验/NCT02941770
NCT02941770Unknown不适用

The Effect of a Physical Activity Consultation in the Management of Adolescent Overweight, Including Anthropometry, Physical Activity Levels, Cardiorespiratory Fitness, and Endothelial Health

University of Lisbon2 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
165
试验地点
2
主要终点
Sedentary behavior

研究概览

简要总结

The prevalence of pediatric obesity makes this condition a worldwide public health concern. Physical Activity (PA) is recognized as having many health benefits, many of them related to obesity and its comorbidities. Despite of all the efforts, the majority of the overweight children/adolescents still present low levels of PA and high levels of sedentary behaviors. Thus, it seems that the greatest challenge is to influence behavior change in order to increase PA exposure in this population. PA consultation can be a cost-effective way of enhancing PA and improve weight status among overweight children.

The main objective of this study is to analyze if the inclusion of a PA consultation in a multidisciplinary program for the management of adolescent overweight improves body mass index (BMI) z-score, PA levels and sedentary behavior outcomes at six and twelve months, compared to those attending only the Pediatric and the Dietetic consultations.

This study was designed as a non-randomized, controlled clinical trial with six months duration and follow-up at the 12th month, that will include overweight adolescents (BMI ≥ p85) aged 12 to 17, attending the Clinic for the first time, and accepted to be enrolled. Those with (i) major pathologies (other than obesity or its related comorbidities), (ii) inability to perform regular PA, (iii) mental disorders, (iv) smoking habits, (v) under any kind of prescription (other than antihypertensives or metformin), or (vi) being involved in another weight loss program will be excluded. According to the sample size calculation, we expect to recruit 129 participants that will be allocated in three groups by consecutive sampling: (i) control group - standard care (Pediatric and Dietitian consultations); (ii) intervention group I - standard care plus PA consultation; (iii) intervention group II - 2 weekly exercise sessions additionally to the standard care and PA consultations..

详细描述

Secondary objectives

The success of adolescent obesity management cannot be assessed only based on the BMI/BMI z-score or PA levels. Thus, the secondary objectives of this study are:

(i) Analyze the effect of the intervention on cardiorespiratory fitness (CRF). CRF is commonly expressed as VO2 max and represents the ability to uptake, deliver, and use oxygen to produce energy. CRF is inversely associated with BMI and waist circumference, and have a potential beneficial effect on the endothelial function and structure - which is known to be impaired among overweight adolescents - even without the occurrence of major changes in the BMI.

(ii) Analyze the effect of the intervention on biochemical markers, including insulin resistance and lipid profile.

(iii) Analyze whether changes in BMI z-score, PA/sedentary behavior and CRF are associated with changes in endothelial structural health (assessed trough carotid intima-media thickness - cIMT) and function (assessed trough pulse wave velocity - PWV).

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
Double (Participant, Investigator)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Coming from the Lisbon region;
  • A BMI ≥ p85 for gender and age;
  • Attending the Clinic for the first time;
  • Accepted to be enrolled.

排除标准

  • Major pathologies (other than obesity or its related comorbidities);
  • Inability to perform regular PA;
  • Mental disorders;
  • Smoking habits;
  • Under any kind of prescription (other than antihypertensives or metformin);
  • Being involved in another weight loss program.

结局指标

主要结局

Sedentary behavior

时间窗: 12 months

Questionnaire ASAQ (Adolescent Sedentary Activity Questionnaire)

Physical activity (PA) levels

时间窗: 12 months

Body mass index (BMI) z-score

时间窗: 12 months

次要结局

  • Cardiorespiratory fitness (CRF)(12 months)
  • Pulse wave velocity (PWV)(12 months)
  • Cost-effectiveness (CE)(12 months)
  • Carotid intima-media thickness (cIMT)(12 months)
  • Lipid profile (TC, LDL-C, HDL-C)(12 months)
  • Glucose metabolism (Glucose, Insulin, HOMA-IR)(12 months)
  • inflammation (C-RP)(12 months)
  • Body composition(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

A. Videira-Silva

PhD student

University of Lisbon

研究点 (2)

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