Clinical trial NCT02980393: Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects
Official title: The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Pediatric Obesity
Keywords: congenital heart disease
smart mobile technology
children
adolescents
lifestyle counselling
nutrition
physical activity
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: London Health Sciences Centre
First posted: 2016-12-02
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Baseline Body Mass Index (BMI) at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Fat Mass at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Lean Mass at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Percent Fat at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Percent Android Fat at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Visceral Adipose Tissue at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Bone Mineral Content at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Maximum Oxygen Consumption at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Secondary outcomes:
measure: Change in Baseline Average Caloric Intake at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Self-Report Physical Activity Levels at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Physical Activity Levels at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Quality of Life at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Muscle function at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Electrocardiographic measurement at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Transthoracic echocardiographic measurement at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Endothelial vasodilator function at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Lipid Profile at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Electrolytes at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Creatinine at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Urea at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Fasting Glucose at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Serum Insulin at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
measure: Change in Baseline Adiponectin at 1 year
timeFrame: This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame
Other outcomes:
Locations:
Study officials:
affiliation: London Health Science Centre
name: Kambiz Norozi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rombeek M, De Jesus S, Altamirano-Diaz L, Welisch E, Prapavessis H, Seabrook JA, Norozi K. The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial. Pilot Feasibility Stud. 2017 Nov 15;3:59. doi: 10.1186/s40814-017-0207-y. eCollection 2017.