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多学科干预计划对超重肥胖儿童肝脏脂肪沉积的影响:EFIGRO研究方案

The effect of a multidisciplinary intervention program on hepatic adiposity in overweight-obese children: protocol of the EFIGRO study.

作者信息

Medrano M, Maiz E, Maldonado-Martín S, Arenaza L, Rodríguez-Vigil B, Ortega F B, Ruiz J R, Larrarte E, Diez-López I, Sarasúa-Miranda A, Tobalina I, Barrenechea L, Pérez-Asenjo J, Kannengiesser S, Manhães-Savio A, Echaniz O, Labayen I

机构信息

Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Physical Education and Sport, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain.

Nutrition, Exercise and Health Research Group, Elikadura, Ariketa Fisikoa eta Osasuna, ELIKOS group, University of the Basque Country, UPV/EHU, Vitoria-Gasteiz, Spain; Department of Personality, Assessment and Psychological Treatment, University of the Basque Country, UPV/EHU, San Sebastián-Donostia, Spain.

出版信息

Contemp Clin Trials. 2015 Nov;45(Pt B):346-355. doi: 10.1016/j.cct.2015.09.017. Epub 2015 Sep 25.

Abstract

BACKGROUND

Non-alcoholic fatty liver disease is the most frequent liver abnormality observed in overweight or obese children and is strongly associated with metabolic syndrome and insulin resistance.

OBJECTIVES

(i) To evaluate the effect of a 22-week multidisciplinary intervention program on hepatic fat fraction in overweight or obese children and (ii) to examine the effect of the intervention on cardiometabolic risk factors, self-esteem and well-being.

METHODS

A total of 160 children, 9-11 years, will be recruited by pediatricians and randomly assigned to control (N = 80) or intervention (N = 80) groups. The control group will receive a family-based lifestyle and psycho-educational program (2 days/month), while the intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program (3 days/week). The duration of training sessions will be 90 min of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises. The primary outcome is the change in hepatic fat fraction (magnetic resonance imaging, MRI). Secondary outcomes include cardiometabolic risk factors such as total adiposity (dual Xray absorptiometry), visceral adiposity (MRI), functional peak aerobic capacity (cardiopulmonary exercise testing), blood pressure, muscular fitness, speed–agility, and fasting blood insulin, glucose, C-reactive protein, alanine aminotransferase, aspartate aminotransferase, gamma glutamyltransferase, lipid profile and psychological measurements (questionnaires). All the measurements will be evaluated at baseline prior to randomization and after the intervention.

DISCUSSION

This study will provide insight in the efficacy of a multidisciplinary intervention program including healthy lifestyle education, psycho-education and supervised exercise to reduce hepatic fat and cardiometabolic risk in overweight children.

摘要

背景

非酒精性脂肪性肝病是超重或肥胖儿童中最常见的肝脏异常,与代谢综合征和胰岛素抵抗密切相关。

目的

(i)评估一项为期22周的多学科干预计划对超重或肥胖儿童肝脏脂肪分数的影响,以及(ii)研究该干预对心脏代谢危险因素、自尊和幸福感的影响。

方法

儿科医生将招募160名9至11岁的儿童,并将其随机分为对照组(N = 80)或干预组(N = 80)。对照组将接受基于家庭的生活方式和心理教育计划(每月2天),而干预组将参加相同的生活方式教育和心理教育计划,并加上运动计划(每周3天)。训练课程时长为90分钟的运动,包括热身、中度至剧烈的有氧运动和力量训练。主要结局是肝脏脂肪分数的变化(磁共振成像,MRI)。次要结局包括心脏代谢危险因素,如总体脂(双能X线吸收法)、内脏脂肪(MRI)、功能性峰值有氧能力(心肺运动测试)、血压、肌肉健康、速度敏捷性,以及空腹血胰岛素、血糖、C反应蛋白、丙氨酸转氨酶、天冬氨酸转氨酶、γ-谷氨酰转移酶、血脂谱和心理测量(问卷调查)。所有测量将在随机分组前的基线和干预后进行评估。

讨论

本研究将深入了解一项多学科干预计划的效果,该计划包括健康生活方式教育、心理教育和监督运动,以降低超重儿童的肝脏脂肪和心脏代谢风险。

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