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

Study Overview
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Brief Summary
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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.

Official Title
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The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects

Conditions
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Congenital Heart Disease, Pediatric Obesity

Intervention / Treatment
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* Behavioral: Lifestyle intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle intervention<br>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. | Behavioral: Lifestyle intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Body Mass Index (BMI) at 1 year | BMI is derived from body mass divided by the square of the body height | 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. | 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. | 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. | 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. | 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. | 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. | This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame | 
| Change in Baseline Maximum Oxygen Consumption at 1 year | Maximal exercise graded treadmill test will determine maximal oxygen consumption. | This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Average Caloric Intake at 1 year | Average caloric intake is estimated from three-day food records. | 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, smart mobile technology, children, adolescents, lifestyle counselling, nutrition, physical activity