Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00746460
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2008-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Healthy Options Feasibility Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D000073865', 'term': 'Cigarette Smoking'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D016540', 'term': 'Smoking Cessation'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'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'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000073869', 'term': 'Tobacco Smoking'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D064424', 'term': 'Tobacco Use'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-10', 'studyFirstSubmitDate': '2008-09-03', 'studyFirstSubmitQcDate': '2008-09-03', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of using health care providers other than physicians within a GMF to conduct a CV risk assessment and intervention on primary prevention patients', 'timeFrame': '10 months'}], 'secondaryOutcomes': [{'measure': "Patient's CV risk factors and overall CV risk", 'timeFrame': '16 weeks'}, {'measure': "Subject's adherence with lifestyle changes and prescribed medications", 'timeFrame': '16 weeks'}, {'measure': 'Satisfaction of the nurse', 'timeFrame': '10 months'}, {'measure': 'Satisfaction of the patient', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['primary prevention', 'patient knowledge', 'nurse', 'exercise', 'smoking cessation', 'weight loss'], 'conditions': ['Obesity', 'Sedentary Lifestyle', 'Dyslipidemia', 'Hypertension', 'Cigarette Smoking', 'Diabetes']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.myhealthcheckup.com', 'label': 'Web site used by study participants'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that having health care providers other than physicians within a "Groupe de Médecine de Famille" conduct cardiovascular risk assessments and teach lifestyle interventions to primary prevention patients will increase the likelihood that patients will adopt and maintain healthy lifestyles. These objectives will be supported by providing subjects with a cardiovascular risk profile estimating the subject\'s risk of cardiovascular disease and teaching them how to use the resources related to lifestyle changes available on the www.myhealthcheckup.com Web site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects 30-79 years of age without known cardiovascular disease but with one or more risk factors such as obesity, a sedentary lifestyle, dyslipidemia, hypertension, cigarette smoking, or diabetes\n* Have provided informed consent\n* Recent (past 6 months) fasting lipid profile results in the medical charts\n\nExclusion Criteria:\n\n* Unable or unlikely to follow and/or complete study or evidence of uncooperative attitude\n* Subject is not literate in either French or English\n* Subject does not have easy and regular access to the Internet\n* Exercise or weight loss are contra-indicated for medical reasons'}, 'identificationModule': {'nctId': 'NCT00746460', 'briefTitle': 'The Healthy Options Feasibility Study', 'organization': {'class': 'OTHER', 'fullName': 'McGill University'}, 'officialTitle': 'The Effectiveness of CVD Risk Profiles When Used by Allied Health Care Providers (HCP) Within a "Groupe de Médecine de Famille": The Healthy Options Feasibility Study.', 'orgStudyIdInfo': {'id': 'CLIN-08001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Behavioral', 'interventionNames': ['Behavioral: CVD risk profile']}], 'interventions': [{'name': 'CVD risk profile', 'type': 'BEHAVIORAL', 'description': 'Cardiovascular risk assessment and behavioral counselling', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3Z 2A7', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill Cardiovascular Health Improvement Program', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Steven Grover, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McGill Cardiovascualr Health Improvement Program'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director McGill Comprehensive Health Improvement Program', 'investigatorFullName': 'Steven Grover, MD', 'investigatorAffiliation': 'McGill University'}}}}