Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT00398060
Status:
COMPLETED
Last Update Posted:
2008-02-14
First Post:
2006-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'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': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 389}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-13', 'studyFirstSubmitDate': '2006-11-09', 'studyFirstSubmitQcDate': '2006-11-09', 'lastUpdatePostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nutrition (fat, fiber)', 'timeFrame': '0-1 years'}, {'measure': 'Physical activity', 'timeFrame': '0-3 years'}, {'measure': 'Weight', 'timeFrame': '0-3 years'}], 'secondaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '0-3 years'}, {'measure': 'Plasma glucose (fasting, 2 hr challenge)', 'timeFrame': '0-3 years'}, {'measure': 'Serum lipids', 'timeFrame': '0-3 years'}, {'measure': 'Blood pressure (diastolic, systolic)', 'timeFrame': '0-3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['life-style counseling', 'type 2 diabetes', 'prediabetes', 'physical activity', 'diet', 'cognitive-behavioral'], 'conditions': ['Obesity', 'Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '14683570', 'type': 'BACKGROUND', 'citation': 'Uutela A, Absetz P, Nissinen A, Valve R, Talja M, Fogelholm M. Health psychological theory in promoting population health in Paijat-Hame, Finland: first steps toward a type 2 diabetes prevention study. J Health Psychol. 2004 Jan;9(1):73-84. doi: 10.1177/1359105304036103.'}]}, 'descriptionModule': {'briefSummary': 'Life-style change achieved in controlled experimental condition has been shown to prevent type 2 diabetes. The purpose of this study is to evaluate to what extent the life-style change can be achieved in a routine health care setting.', 'detailedDescription': 'The GOAL (Good Ageing in Lahti region) Program Life-style change implementation trial to prevent type 2 diabetes was set to examine and enhance the effectiveness of life-style change counselling in the primary health care. In the intervention, specific nutritional, physical activity and weight loss objectives shown effective in diabetes prevention in an earlier randomised controlled trial are used as a benchmark, embedded in a structured group counselling model with an empowerment-oriented approach and adapted into the primary health care setting. In the trial, effectiveness and process are evaluated, the analyses including gender and socio-economic differences. Participants were 361 middle-aged (50-65 yrs) adults at an increased risk for type 2 diabetes, recruited in 16 primary health care centres in Paijat-Hame, Finland. Intervention and data collection took place in year 2003.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes risk test score \\> 11 (Lindstrom \\& Tuomilehto, 2003)\n\nExclusion Criteria:\n\n* mental health problem or substance abuse likely to interfere with participation\n* acute cancer\n* type 2 diabetes requiring pharmacological treatment\n* myocardial infarction during the past six months'}, 'identificationModule': {'nctId': 'NCT00398060', 'briefTitle': 'GOAL Life-Style Change Intervention to Prevent Type 2 Diabetes', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Finnish Institute for Health and Welfare'}, 'officialTitle': 'GOAL Life-Style Change Implementation Intervention to Prevent Type 2 Diabetes in Primary Health Care', 'orgStudyIdInfo': {'id': 'KTL223-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Behavioral: Cognitive-behavioral life-style counseling']}], 'interventions': [{'name': 'Cognitive-behavioral life-style counseling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15850', 'city': 'Lahti', 'country': 'Finland', 'facility': 'Päijät-Häme Hospital District', 'geoPoint': {'lat': 60.98267, 'lon': 25.66151}}], 'overallOfficials': [{'name': 'Antti Uutela, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Public Health Institute'}, {'name': 'Pilvikki Absetz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Public Health Institute'}, {'name': 'Martti Talja, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Päijät Häme Central Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute for Health and Welfare', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Academy of Finland', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Senior researcher Pilvikki Absetz', 'oldOrganization': 'National Public Health Institute'}}}}