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

Congenital Heart Disease Clinical Trial

— SHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980393
• Other study ID #: 102392
• Secondary ID: 18843
• Status: Completed
• Phase: N/A
• First received: November 24, 2016
• Last updated: December 20, 2016
• Start date: May 2012
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Overweight
• Pediatric Obesity

Intervention

Behavioral:
• Lifestyle intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kambiz Norozi	London Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No