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

Not Applicable

Completed

• Conditions: Congenital Heart Disease; Pediatric Obesity
• Interventions: Behavioral: Lifestyle intervention

• 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

Arm && Interventions

Group	Intervention	Description
Lifestyle intervention	Lifestyle intervention	Participants are guided by a fitness specialist who will help the participants to incorporate physical activity into their daily life. Based on the cardiologist assessment, an individual home-based exercise program will be developed. Participants are also guided and advised on nutrition with emphasis on low fat content and increased fiber. The nutrition counseling will focus on sustainable changes and will help participants to make healthy food choices.

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.