Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-04 @ 3:45 AM
Study NCT ID:
NCT02492035
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2015-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2015-06-03', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure', 'timeFrame': '6 months'}]}, 'conditionsModule': {'keywords': ['Hypertension', 'lifestyle', 'clinical trials', 'primary care setting'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The Canadian hypertension education program recommends increased physical activity, adoption of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and alcohol intake for treatment and prevention of hypertension. Objective: To describe patients participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a family medicine primary care setting. Design: Descriptive study. Participants: The study aims to recruit 60 sedentary hypertensive patients to participate in a 6-month randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood pressure measurements \\[ABPM\\]), non-smoker, non-diabetic and without dyslipidemia. Intervention: Patients are recruited by health care professionals of the family medicine unit and are thereafter randomized to one of four intervention groups: 1) standard medical care (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet and physical activity. Patients are evaluated (pre, mid and post intervention), monitored, and educated by the interdisciplinary health care team that includes a physician, a kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and descriptive statistics were used to analyse data. This study will document the efficacy of a primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years of age\n* Sedentary (7-day measured steps/day and self-report)\n* Arterial hypertensive (based on 24-h ambulatory blood pressure measurements \\[ABPM\\])\n\nExclusion Criteria:\n\n* secondary hypertension\n* diabetes\n* dyslipidemia\n* cardiovascular diseases with complications\n* smoker'}, 'identificationModule': {'nctId': 'NCT02492035', 'briefTitle': 'Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting', 'orgStudyIdInfo': {'id': '20805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity', 'description': 'Tailoring intervention with kinesiologist', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Diet', 'description': 'Tailoring intervention with nutritionist', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Physical activity and diet', 'description': 'Tailoring intervention with kinesiologist and nutritionist', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Standard medical care', 'description': 'Follow with family doctor as usual care.'}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Diet', 'Physical activity', 'Physical activity and diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V0B7', 'city': 'Québec', 'country': 'Canada', 'facility': 'GMF-UMF Laval-Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Caroline Rhéaume, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation IUCPQ', 'class': 'OTHER'}, {'name': 'CSSS-VC', 'class': 'UNKNOWN'}, {'name': 'GMF-UMF Laval-Québec', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD, clinical researcher', 'investigatorFullName': 'Caroline', 'investigatorAffiliation': 'Laval University'}}}}