NCT02980393

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Kambiz Norozi · Academic / Other
• Sex: All
• Age: 7 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Heart Disease
• Pediatric Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-05-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-12-02
• Last updated: 2016-12-22