Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Pediatric Obesity

• Registration Number: NCT02980393
• Lead Sponsor: Kambiz Norozi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Study First Submitted: 2016-11-24
• Study First Submitted QC: 2016-11-29
• Status Verified: 2016-12
• Study First Posted: 2016-12-02
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Baseline Fat Mass at 1 year	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Change in Baseline Adiponectin at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Blood is drawn from patients who have been asked to fast for at least 10 hours.
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	Physical activity levels will be measured from accelerometers
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	Physical activity levels will also be measured by the Physical Activity Questionnaire for Older Children
Change in Baseline Muscle function at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Leonardo Mechanograph® Ground Reaction Force Plate will assess jumping height.
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	Echo-cardiogram will be employed.
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	Peripheral arterial tonometry will assess endothelial vasodilator function.
Change in Baseline Creatinine at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Blood is drawn from patients who have been asked to fast for at least 10 hours.
Change in Baseline Electrocardiographic measurement at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Electrocardiogram
Change in Baseline Urea at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Blood is drawn from patients who have been asked to fast for at least 10 hours.
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	Average caloric intake is estimated from three-day food records.
Change in Baseline Electrolytes at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Blood is drawn from patients who have been asked to fast for at least 10 hours.
Change in Baseline Fasting Glucose at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Blood is drawn from patients who have been asked to fast for at least 10 hours.
Change in Baseline Serum Insulin at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Blood is drawn from patients who have been asked to fast for at least 10 hours.
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	Pediatric Quality of Life Inventory Generic Core Scales
Change in Baseline Lipid Profile at 1 year	This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame	Blood is drawn from patients who have been asked to fast for at least 10 hours.