Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-02-24 @ 10:54 AM
Study NCT ID:
NCT02980393
Status:
COMPLETED
Last Update Posted:
2016-12-22
First Post:
2016-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-20', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2016-11-29', 'lastUpdatePostDateStruct': {'date': '2016-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'BMI is derived from body mass divided by the square of the body height'}, {'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', 'description': 'Dual energy x-ray absorptiometry (DEXA) will measure fat mass.'}, {'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', 'description': 'Dual energy x-ray absorptiometry (DEXA) will measure lean mass.'}, {'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', 'description': 'Dual energy x-ray absorptiometry (DEXA) will measure percent fat.'}, {'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', 'description': 'Dual energy x-ray absorptiometry (DEXA) will measure percent android fat.'}, {'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', 'description': 'Dual energy x-ray absorptiometry (DEXA) will measure visceral adipose tissue.'}, {'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', 'description': 'Dual energy x-ray absorptiometry (DEXA) will measure bone mineral content.'}, {'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', 'description': 'Maximal exercise graded treadmill test will determine maximal oxygen consumption.'}], 'secondaryOutcomes': [{'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', 'description': 'Average caloric intake is estimated from three-day food records.'}, {'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', '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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', 'timeFrame': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['congenital heart disease', 'smart mobile technology', 'children', 'adolescents', 'lifestyle counselling', 'nutrition', 'physical activity'], 'conditions': ['Congenital Heart Disease', 'Pediatric Obesity']}, 'referencesModule': {'references': [{'pmid': '29167745', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight or obese (BMI\\> 85%) patients\n* between 7-17 years of age\n* operated or non-operated congenital heart disease\n* reside in Southwestern Ontario\n\nExclusion Criteria:\n\n* inability to comply with research testing or intervention components due to mental and/or physical disabilities, medications or comorbidities affecting weight or metabolic condition\n* involvement in any concurrent lifestyle intervention program'}, 'identificationModule': {'nctId': 'NCT02980393', 'acronym': 'SHT', 'briefTitle': 'Smart Heart Trial: Structured Lifestyle Intervention for Overweight and Obese Youth With Operated Heart Defects', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'The Impact of a Structured Lifestyle Intervention on Body Composition and Exercise Capacity in Overweight Children With Operated Heart Defects', 'orgStudyIdInfo': {'id': '102392'}, 'secondaryIdInfos': [{'id': '18843', 'type': 'OTHER', 'domain': 'UWesternOntario'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle intervention', '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.', 'interventionNames': ['Behavioral: Lifestyle intervention']}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Lifestyle intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kambiz Norozi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Science Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kambiz Norozi', 'class': 'OTHER'}, 'collaborators': [{'name': 'London Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Paediatric Cardiologist', 'investigatorFullName': 'Kambiz Norozi', 'investigatorAffiliation': 'Western University, Canada'}}}}