<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02980393</url>
  </required_header>
  <id_info>
    <org_study_id>102392</org_study_id>
    <secondary_id>18843</secondary_id>
    <nct_id>NCT02980393</nct_id>
  </id_info>
  <brief_title>Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects</brief_title>
  <acronym>SHT</acronym>
  <official_title>The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kambiz Norozi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to assess whether a lifestyle intervention with diet, exercise and counselling&#xD;
      in young patients will have a positive influence on their weight and overall well-being. This&#xD;
      study will enrol patients between the ages of 7 to 17 years of age, who have congenital heart&#xD;
      disease, and have been identified being overweight or obese. A total of 40 individuals will&#xD;
      participate in this study. The study duration will last for 1 year.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Baseline Body Mass Index (BMI) at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>BMI is derived from body mass divided by the square of the body height</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Fat Mass at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Dual energy x-ray absorptiometry (DEXA) will measure fat mass.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Lean Mass at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Dual energy x-ray absorptiometry (DEXA) will measure lean mass.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Percent Fat at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Dual energy x-ray absorptiometry (DEXA) will measure percent fat.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Percent Android Fat at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Visceral Adipose Tissue at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Bone Mineral Content at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Baseline Maximum Oxygen Consumption at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Maximal exercise graded treadmill test will determine maximal oxygen consumption.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Average Caloric Intake at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Average caloric intake is estimated from three-day food records.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Self-Report Physical Activity Levels at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Physical activity levels will also be measured by the Physical Activity Questionnaire for Older Children</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Physical Activity Levels at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Physical activity levels will be measured from accelerometers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Quality of Life at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Pediatric Quality of Life Inventory Generic Core Scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Muscle function at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Leonardo Mechanograph® Ground Reaction Force Plate will assess jumping height.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Electrocardiographic measurement at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Electrocardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Transthoracic echocardiographic measurement at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Echo-cardiogram will be employed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Endothelial vasodilator function at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Peripheral arterial tonometry will assess endothelial vasodilator function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Lipid Profile at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Blood is drawn from patients who have been asked to fast for at least 10 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Electrolytes at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Blood is drawn from patients who have been asked to fast for at least 10 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Creatinine at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Blood is drawn from patients who have been asked to fast for at least 10 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Urea at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Blood is drawn from patients who have been asked to fast for at least 10 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Fasting Glucose at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Blood is drawn from patients who have been asked to fast for at least 10 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Serum Insulin at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Blood is drawn from patients who have been asked to fast for at least 10 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline Adiponectin at 1 year</measure>
    <time_frame>This outcome was measured at Baseline, 6 months, 1 year within the 1 year time frame</time_frame>
    <description>Blood is drawn from patients who have been asked to fast for at least 10 hours.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Congenital Heart Disease</condition>
  <condition>Pediatric Obesity</condition>
  <arm_group>
    <arm_group_label>Lifestyle intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle intervention</intervention_name>
    <description>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.</description>
    <arm_group_label>Lifestyle intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  overweight or obese (BMI&gt; 85%) patients&#xD;
&#xD;
          -  between 7-17 years of age&#xD;
&#xD;
          -  operated or non-operated congenital heart disease&#xD;
&#xD;
          -  reside in Southwestern Ontario&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to comply with research testing or intervention components due to mental&#xD;
             and/or physical disabilities, medications or comorbidities affecting weight or&#xD;
             metabolic condition&#xD;
&#xD;
          -  involvement in any concurrent lifestyle intervention program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kambiz Norozi, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Science Centre</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Western University, Canada</investigator_affiliation>
    <investigator_full_name>Kambiz Norozi</investigator_full_name>
    <investigator_title>Paediatric Cardiologist</investigator_title>
  </responsible_party>
  <keyword>congenital heart disease</keyword>
  <keyword>smart mobile technology</keyword>
  <keyword>children</keyword>
  <keyword>adolescents</keyword>
  <keyword>lifestyle counselling</keyword>
  <keyword>nutrition</keyword>
  <keyword>physical activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Pediatric Obesity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02980393
org study id: 102392
secondary id: 18843
nct id: NCT02980393
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 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
description: BMI is derived from body mass divided by the square of the body height
measure: 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
description: Dual energy x-ray absorptiometry (DEXA) will measure fat mass.
measure: 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
description: Dual energy x-ray absorptiometry (DEXA) will measure lean mass.
measure: 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
description: Dual energy x-ray absorptiometry (DEXA) will measure percent fat.
measure: 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
description: Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.
measure: 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
description: Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.
measure: 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
description: Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.
measure: 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
description: Maximal exercise graded treadmill test will determine maximal oxygen consumption.
measure: 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
description: Average caloric intake is estimated from three-day food records.
measure: 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
description: Physical activity levels will also be measured by the Physical Activity Questionnaire for Older Children
measure: 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
description: Physical activity levels will be measured from accelerometers
measure: 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
description: Pediatric Quality of Life Inventory Generic Core Scales
measure: 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
description: Leonardo Mechanograph® Ground Reaction Force Plate will assess jumping height.
measure: 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
description: Electrocardiogram
measure: 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
description: Echo-cardiogram will be employed.
measure: 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
description: Peripheral arterial tonometry will assess endothelial vasodilator function.
measure: 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
description: Blood is drawn from patients who have been asked to fast for at least 10 hours.
measure: 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
description: Blood is drawn from patients who have been asked to fast for at least 10 hours.
measure: 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
description: Blood is drawn from patients who have been asked to fast for at least 10 hours.
measure: 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
description: Blood is drawn from patients who have been asked to fast for at least 10 hours.
measure: 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
description: Blood is drawn from patients who have been asked to fast for at least 10 hours.
measure: 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
description: Blood is drawn from patients who have been asked to fast for at least 10 hours.
measure: 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
description: Blood is drawn from patients who have been asked to fast for at least 10 hours.
arm group label: Lifestyle intervention
arm group type: Experimental
description: 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.
intervention type: Behavioral
intervention name: Lifestyle intervention
description: 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.
arm group label: Lifestyle intervention
criteria: 
gender: All
minimum age: 7 Years
maximum age: 17 Years
healthy volunteers: No
last name: Kambiz Norozi, MD, PhD
role: Principal Investigator
affiliation: London Health Science Centre
responsible party type: Sponsor-Investigator
investigator affiliation: Western University, Canada
investigator full name: Kambiz Norozi
investigator title: Paediatric Cardiologist
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Overweight
mesh term: Pediatric Obesity