Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-27 @ 11:24 AM
Study NCT ID:
NCT04425304
Status:
COMPLETED
Last Update Posted:
2024-12-11
First Post:
2020-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2020-06-06', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2024-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Baseline to 2 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The aim of the trial is to study the effect of a lifestyle change program in patients with obesity and risk of cardiovascular diseases. The main focus is to motivate and support lifestyle changes.\n\nTwo different group counseling methods (intensive and standard) with or without internet support will be compared. Thus, the patients will be randomized into four arms. Patients will be recruited from local general practice teams. The intensive lifestyle counseling consists of 12 group counseling sessions and 2 personal counseling sessions. The standard counseling consists of 4 group sessions. The internet-based counseling contains aspects of cognitive behavior therapy and persuasive design system and consists of weekly reminders, tasks, self-monitoring, and reflection.\n\nThe main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, eating habits, components of metabolic syndrome (waist circumference, plasma lipid and glucose values), and calculated scores of cardiometabolic condition, cardiovascular risk and adiposity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index 30 to 40 kg/m2\n* \\+ 2 risk factors of cardiovascular diseases:\n\n * Elevated blood pressure or hypertension\n * High LDL or hypocholesterolemic drug\n * Low HDL or hypocholesterolemic drug\n * Elevated triglyceride value or hypolipidemic drug\n * Elevated glucose value or diabetes medication\n * Smoking\n* Access to email and internet\n\nExclusion Criteria:\n\n* Untreated hypothyroidism\n* Oral corticosteroid treatment\n* Pregnancy and lactation\n* Angina pectoris\n* Cardiac insufficiency\n* Coronary Heart Disease\n* Inability to speak Finnish\n* Anticipated lack of compliance'}, 'identificationModule': {'nctId': 'NCT04425304', 'briefTitle': 'Effects of Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'The Effects of an Efficient Lifestyle Counseling Method on the Risks of Cardiovascular Disease in Health Care Center Patients', 'orgStudyIdInfo': {'id': 'Resepti-Onnikka'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group counseling', 'interventionNames': ['Behavioral: Group counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Group counseling + persuasive ICT support', 'interventionNames': ['Behavioral: Group counseling', 'Behavioral: Persuasive ICT support']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intensive group counseling', 'interventionNames': ['Behavioral: Intensive group counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Intensive group counseling + persuasive ICT support', 'interventionNames': ['Behavioral: Intensive group counseling', 'Behavioral: Persuasive ICT support']}], 'interventions': [{'name': 'Group counseling', 'type': 'BEHAVIORAL', 'description': '4 times', 'armGroupLabels': ['Group counseling', 'Group counseling + persuasive ICT support']}, {'name': 'Intensive group counseling', 'type': 'BEHAVIORAL', 'description': '14 times', 'armGroupLabels': ['Intensive group counseling', 'Intensive group counseling + persuasive ICT support']}, {'name': 'Persuasive ICT support', 'type': 'BEHAVIORAL', 'description': 'Weekly reminders for 12 months', 'armGroupLabels': ['Group counseling + persuasive ICT support', 'Intensive group counseling + persuasive ICT support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90029 OYS', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Janne Hukkanen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oulu, Oulu University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine', 'investigatorFullName': 'Janne Hukkanen', 'investigatorAffiliation': 'University of Oulu'}}}}