The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Change in Baseline Fat Mass at 1 year
研究概览
简要总结
This study is to assess whether a lifestyle intervention with diet, exercise and counselling in young patients will have a positive influence on their weight and overall well-being. This study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart disease, and have been identified being overweight or obese. A total of 40 individuals will participate in this study. The study duration will last for 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •overweight or obese (BMI> 85%) patients
- •between 7-17 years of age
- •operated or non-operated congenital heart disease
- •reside in Southwestern Ontario
排除标准
- •inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition
- •involvement in any concurrent lifestyle intervention program
结局指标
主要结局
Change in Baseline Fat Mass at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Dual energy x-ray absorptiometry (DEXA) will measure fat mass.
Change in Baseline Visceral Adipose Tissue at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.
Change in Baseline Lean Mass at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Dual energy x-ray absorptiometry (DEXA) will measure lean mass.
Change in Baseline Bone Mineral Content at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.
Change in Baseline Percent Fat at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Dual energy x-ray absorptiometry (DEXA) will measure percent fat.
Change in Baseline Body Mass Index (BMI) at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
BMI is derived from body mass divided by the square of the body height
Change in Baseline Percent Android Fat at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.
Change in Baseline Maximum Oxygen Consumption at 1 year
时间窗: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Maximal exercise graded treadmill test will determine maximal oxygen consumption.
次要结局
- Change in Baseline Adiponectin at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Physical Activity Levels at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Self-Report Physical Activity Levels at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Muscle function at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Transthoracic echocardiographic measurement at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Endothelial vasodilator function at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Creatinine at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Electrocardiographic measurement at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Urea at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Average Caloric Intake at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Electrolytes at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Fasting Glucose at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Serum Insulin at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Quality of Life at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
- Change in Baseline Lipid Profile at 1 year(This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame)
研究者
Kambiz Norozi
Paediatric Cardiologist
Western University, Canada