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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
The structured lifestyle intervention involves alternating weekly phone calls with two health coaches: a registered dietitian and a fitness specialist. A total of 50 phone calls (25 nutrition-related and 25 physical activity-related) are delivered over the one-year study. After six months in the program, participants are introduced to supporting program-specific software that they can access online, as an additional way to interact with the program, set goals, and record their progress. Client and family-centred nutrition and physical activity counselling includes an initial and regular behavioural assessment, and subsequent conversations (i.e., phone calls) using motivational interviewing techniques intended to increase knowledge or skills, and improve behaviours.
Change in Baseline Body Mass Index (BMI) at 1 year
BMI is derived from body mass divided by the square of the body height
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Fat Mass at 1 year
Dual energy x-ray absorptiometry (DEXA) will measure fat mass.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Lean Mass at 1 year
Dual energy x-ray absorptiometry (DEXA) will measure lean mass.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Percent Fat at 1 year
Dual energy x-ray absorptiometry (DEXA) will measure percent fat.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Percent Android Fat at 1 year
Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Visceral Adipose Tissue at 1 year
Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Bone Mineral Content at 1 year
Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
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Change in Baseline Maximum Oxygen Consumption at 1 year
Maximal exercise graded treadmill test will determine maximal oxygen consumption.
Time frame: 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
Average caloric intake is estimated from three-day food records.
Time frame: 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
Physical activity levels will also be measured by the Physical Activity Questionnaire for Older Children
Time frame: 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
Physical activity levels will be measured from accelerometers
Time frame: 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
Pediatric Quality of Life Inventory Generic Core Scales
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Muscle function at 1 year
Leonardo Mechanograph® Ground Reaction Force Plate will assess jumping height.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Electrocardiographic measurement at 1 year
Electrocardiogram
Time frame: 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
Echo-cardiogram will be employed.
Time frame: 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
Peripheral arterial tonometry will assess endothelial vasodilator function.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Lipid Profile at 1 year
Blood is drawn from patients who have been asked to fast for at least 10 hours.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Electrolytes at 1 year
Blood is drawn from patients who have been asked to fast for at least 10 hours.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Creatinine at 1 year
Blood is drawn from patients who have been asked to fast for at least 10 hours.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Urea at 1 year
Blood is drawn from patients who have been asked to fast for at least 10 hours.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Fasting Glucose at 1 year
Blood is drawn from patients who have been asked to fast for at least 10 hours.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Serum Insulin at 1 year
Blood is drawn from patients who have been asked to fast for at least 10 hours.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Change in Baseline Adiponectin at 1 year
Blood is drawn from patients who have been asked to fast for at least 10 hours.
Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame