The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Congenital Heart Disease
- Sponsor
- Kambiz Norozi
- Enrollment
- 40
- Primary Endpoint
- Change in Baseline Fat Mass at 1 year
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Investigators
Kambiz Norozi
Paediatric Cardiologist
Western University, Canada
Eligibility Criteria
Inclusion Criteria
- •overweight or obese (BMI\> 85%) patients
- •between 7-17 years of age
- •operated or non-operated congenital heart disease
- •reside in Southwestern Ontario
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Change in Baseline Fat Mass at 1 year
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)