Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-02-23 @ 9:22 PM
Study NCT ID:
NCT02730559
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2016-03-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}, {'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003153', 'term': 'Community Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2016-04-05', 'studyFirstSubmitDate': '2016-03-31', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in total cholesterol to HDL-C ratio', 'timeFrame': 'Initial clinic visit (baseline); Repeated 6 months after baseline;'}]}, 'conditionsModule': {'keywords': ['Motivational Interviewing'], 'conditions': ['Dyslipidemias']}, 'descriptionModule': {'briefSummary': "The primary focus of this proposal is to address growing concern of overweight/ obese adolescents with hyperlipidemia. The proposed study is a 2-arm randomized controlled clinical trial to compare the effectiveness of Motivational interviewing (MI) interventions with the parent and adolescent dyad versus adolescent (10-17yr) alone. The patients will be recruited from the Lipid clinic at Sick Kids. The study hypothesis is that parent child dyad will have more success due to the possible synergetic effect compared to adolescents alone. The study's primary outcome is cholesterol levels (Triglycerides/HDL ratio) and secondary outcomes include overall improvement in their lifestyle and their responses to the MI intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at randomization: 10-17 years old\n* 12 hour fasting lipid profile with triglycerides ≥39 mg/dL (1.0 mmol/L) or HDL-C ≤46 mg/dL (1.2 mmol/L), and with non-HDL-C ≥123 mg/dL (3.2 mmol/L)\n* Waist to height ratio ≥0.5.\n\nExclusion Criteria:\n\n* On lipid lowering medication\n* non-English speaking\n* Developmentally delayed'}, 'identificationModule': {'nctId': 'NCT02730559', 'briefTitle': 'Motivational Interviewing With Dyslipidemic Adolescents Together With a Parent Versus With Adolescents Alone: A Mixed Methods Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'orgStudyIdInfo': {'id': '1000035605'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Group A (Parent-adolescent dyads)', 'interventionNames': ['Other: Motivational Interviewing/Counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group - Active Comparator', 'description': 'Group B (Adolescents only)', 'interventionNames': ['Other: Motivational Interviewing/Counselling']}], 'interventions': [{'name': 'Motivational Interviewing/Counselling', 'type': 'OTHER', 'description': 'Motivational Interviewing/Counselling', 'armGroupLabels': ['Control Group - Active Comparator', 'Intervention Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Cardiologist', 'investigatorFullName': 'Brian McCrindle', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}