Efficacy of a Structured Exercise Prescription Program Over Anthropometric, Metabolic and Fitness Parameters in Obese Children and Adolescents Included in a Multicomponent Lifestyle Intervention Program. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- VO2 max
研究概览
简要总结
This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months.
The parameters that will be evaluated between groups are physical fitness, anthropometry, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage, inflammatory biomarkers, anxiety and depression scores, and allelic variants related to physical fitness.
详细描述
This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity (study group) with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months.
The parameters that will be evaluated between groups are physical fitness (measured by VO2max, ECG at rest, biomechanics and dynamometry), anthropometric measurements (weight height, BMI, plicometry, bioimpedance, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage (carotid intima-media thickness, atherogenic dyslipidemia), inflammatory biomarkers (leptin, adiponectin, IL-17, IL-10, INF-gamma, IL-6, IL-12, y TNF-alpha), anxiety and depression scores evaluated with Child Depression Inventory (CID) and -Trait Anxiety Inventory for Children (STAI-CH), and allelic variants related to physical fitness (ACTN, TRH2 y FTO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial
入排标准
- 年龄范围
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with BMI ≥ Pc 95 and < 35kg/m2 Both sexes Accepts to participate and signs informed consent
排除标准
- •Presence of endocrine disease including type I and II diabetes mellitus Presence of arterial hypertension Presence of primary dyslipidemia Presence of infections at moment of enrollment Presence of systemic disease Presence of genetic disorder Medical treatment that may interfere with lipid or glucose metabolism Prolonged or acute immobilization Participated in a previous similar intervention
研究组 & 干预措施
Personalized structured exercise
This group will be enrolled in a multicomponent program for obese children (8-12 years old) that includes intervention workshops concerning nutrition, emotional factors, cognitive therapy and personalized structured exercise prescription that will be offered on-site and online and monitored through the use of heart rate monitoring devices. The type of exercise offered to patients in this arm is precisely designed for obese patients according to age and physical fitness parameters.
Intervention: Non-personalized non-structured exercise
干预措施: Personalized structured exercise program (Other)
Non-personalized non-structured exercise
This group will be enrolled in a multicomponent program for obese children (8-12 years old) that includes intervention workshops concerning nutrition, emotional factors, cognitive therapy and non-personalized non-structured exercise prescription Intervention: Non-personalized non-structured exercise
干预措施: Non personalized non-structured exercise program (Other)
结局指标
主要结局
VO2 max
时间窗: 6 months
Changes in VO2 max as fitness indicator
OGTT
时间窗: 6 months
Oral glucose tolerance test
次要结局
- Lean body mass(6 months)
- BMI(6 months)
- AST(6 months)
- ALT(6 months)
- GGT(6 months)
- Leptin(6 months)
- Adiponectin(6 months)
研究者
Nayely Garibay Nieto
Head of the Child and Adolescent Obesity Clinic
Hospital General de México Dr. Eduardo Liceaga