Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-03-04 @ 7:52 PM
Study NCT ID:
NCT00665158
Status:
COMPLETED
Last Update Posted:
2011-10-31
First Post:
2008-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention and Reduction of Obesity Through Active Living
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D056128', 'term': 'Obesity, Abdominal'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-27', 'studyFirstSubmitDate': '2008-04-21', 'studyFirstSubmitQcDate': '2008-04-22', 'lastUpdatePostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waist Circumference', 'timeFrame': '2 Years'}], 'secondaryOutcomes': [{'measure': 'Metabolic Syndrome', 'timeFrame': '2 Years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abdominal obesity, exercise, behaviour modification'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '22371872', 'type': 'DERIVED', 'citation': 'Ross R, Lam M, Blair SN, Church TS, Godwin M, Hotz SB, Johnson A, Katzmarzyk PT, Levesque L, MacDonald S. Trial of prevention and reduction of obesity through active living in clinical settings: a randomized controlled trial. Arch Intern Med. 2012 Mar 12;172(5):414-24. doi: 10.1001/archinternmed.2011.1972. Epub 2012 Feb 27.'}]}, 'descriptionModule': {'briefSummary': 'We will perform a randomized, controlled trial, the primary aim of which is to assess the effectiveness of a behavioral-based physical activity program in the prevention and treatment of obesity and related co-morbid conditions in a primary care setting. We hypothesize that the prevention and/or reduction of obesity and related co-morbidities in patients randomized to an individualized education and behavior counseling group will be greater by comparison to those randomized to a group that receives standard care alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women between 25 and 65 years of age.\n* Sedentary lifestyle (planned physical activity for the purpose of health one day per week or less).\n* Abdominally obese (waist circumference greater than 88 and 102 cm for women and men respectively).\n* Weight stable (± 2 kg) for 6 months prior to the beginning of the study.\n* BMI between 25 and 34.9 kg/m2 (Because a lifestyle-based intervention alone for obesity reduction is ideal for persons with a BMI greater less than 35, and, that 94% of overweight and obese Canadian adults have a BMI between 25 and 34.9 kg/m2, subjects with a BMI 35 or greater will be excluded).\n\nExclusion Criteria:\n\n* Physical impairment which would make the intervention very difficult, or unsafe according to the patient's physician including history of myocardial infarction, stroke, coronary bypass surgery or angioplasty in the last 6 months; peripheral artery disease, unstable angina or ischemia, uncontrolled or insulin dependent diabetes mellitus.\n* Alcohol consumption \\> 21 drinks per week.\n* Plans to move from the area.\n* Participating in another research study.\n* Clinically judged to be unsuitable for participation or adherence\n* Inability or unwillingness to provide informed consent.\n* For women, planned pregnancy in the next 3 years."}, 'identificationModule': {'nctId': 'NCT00665158', 'acronym': 'PROACTIVE', 'briefTitle': 'Prevention and Reduction of Obesity Through Active Living', 'organization': {'class': 'OTHER', 'fullName': "Queen's University"}, 'officialTitle': 'Prevention and Reduction of Obesity Through Active Living', 'orgStudyIdInfo': {'id': 'Ross2006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UC', 'description': 'Usual Care Group', 'interventionNames': ['Behavioral: UC (Usual Care Group)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BI', 'description': 'Behavioural Intervention Group', 'interventionNames': ['Behavioral: BI (Behavioral Intervention Group)']}], 'interventions': [{'name': 'UC (Usual Care Group)', 'type': 'BEHAVIORAL', 'description': 'Usual Care Group - Treatment Implementation by Primary Care Physician', 'armGroupLabels': ['UC']}, {'name': 'BI (Behavioral Intervention Group)', 'type': 'BEHAVIORAL', 'description': 'Behavioral Intervention Group - Treatment Implementation by Health Educator', 'armGroupLabels': ['BI']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 3N6', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Queen's University : Physical Education Center", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}], 'overallOfficials': [{'name': 'Robert Ross', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Queen's University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Queen's University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bob Ross', 'investigatorAffiliation': "Queen's University"}}}}