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Completed

NCT Number: NCT02980393

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

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.

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Key information

Conditions

Congenital Heart Disease Behavior Body Weight Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

Primary outcomes

  1. Change in Baseline Body Mass Index (BMI) at 1 year

    Time frame: 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

  2. Change in Baseline Fat Mass at 1 year

    Time frame: 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.

  3. Change in Baseline Lean Mass at 1 year

    Time frame: 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.

  4. Change in Baseline Percent Fat at 1 year

    Time frame: 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.

  5. Change in Baseline Percent Android Fat at 1 year

    Time frame: 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.

  6. Change in Baseline Visceral Adipose Tissue at 1 year

    Time frame: 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.

  7. Change in Baseline Bone Mineral Content at 1 year

    Time frame: 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.

  8. Change in Baseline Maximum Oxygen Consumption at 1 year

    Time frame: 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 outcomes

  1. Change in Baseline Average Caloric Intake at 1 year

    Time frame: 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.

  2. Change in Baseline Self-Report Physical Activity Levels at 1 year

    Time frame: 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

  3. Change in Baseline Physical Activity Levels at 1 year

    Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

    Physical activity levels will be measured from accelerometers

  4. Change in Baseline Quality of Life at 1 year

    Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

    Pediatric Quality of Life Inventory Generic Core Scales

  5. Change in Baseline Muscle function at 1 year

    Time frame: 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.

  6. Change in Baseline Electrocardiographic measurement at 1 year

    Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

    Electrocardiogram

  7. Change in Baseline Transthoracic echocardiographic measurement at 1 year

    Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

    Echo-cardiogram will be employed.

  8. Change in Baseline Endothelial vasodilator function at 1 year

    Time frame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame

    Peripheral arterial tonometry will assess endothelial vasodilator function.

  9. Change in Baseline Lipid Profile at 1 year

    Time frame: 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.

  10. Change in Baseline Electrolytes at 1 year

    Time frame: 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.

  11. Change in Baseline Creatinine at 1 year

    Time frame: 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.

  12. Change in Baseline Urea at 1 year

    Time frame: 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.

  13. Change in Baseline Fasting Glucose at 1 year

    Time frame: 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.

  14. Change in Baseline Serum Insulin at 1 year

    Time frame: 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.

  15. Change in Baseline Adiponectin at 1 year

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kambiz Norozi

Other

Collaborators

  • London Health Sciences Centre

Registry information

Official study title

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

Acronym: SHT

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2016
Registry last updated
Dec 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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