Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-01-13 @ 2:56 PM
Study NCT ID:
NCT02967406
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2017-05-31
First Post:
2016-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Lifestyle Modification on the Development of Dementia, Chronic Kidney Disease, Diabetes, Chronic Obstructive Pulmonary Disease, Cancers and Cardiovascular Disease in a Thai General Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3600}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Physical activity levels', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Physical activity levels assessed using the global physical activity questionnaire (GPAQ)'}, {'measure': 'Diet', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Diet assessed by 24 hour food recall'}, {'measure': 'Prevalence of current smokers', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Percentage of current smokers in the study samples'}, {'measure': 'Prevalence of alcohol consumption', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Percentage of those who report alcohol consumption'}, {'measure': 'Cognitive function', 'timeFrame': '2, 5 and 10 years', 'description': 'Cognitive function assessed by MMSE score'}], 'primaryOutcomes': [{'measure': 'Dementia', 'timeFrame': '10 years', 'description': 'Number of participants with dementia. Incident dementia will be diagnosed by medical specialists (Neuro-Med) following a battery of screening tests, including mini-mental state exam, depression and clock drawing tests.'}], 'secondaryOutcomes': [{'measure': 'Type 2 diabetes mellitus', 'timeFrame': '3, 5 and 10 years', 'description': 'Number of participants with type 2 diabetes mellitus. Diabetes mellitus is biochemically and clinically diagnosed.'}, {'measure': 'Cardiovascular disease', 'timeFrame': '5 and 10 years', 'description': 'Number of participants with cardiovascular disease. Clinical diagnosis of cardiovascular disease. Diagnostic information will be obtained from medical records review and service reimbursement data.'}, {'measure': 'Cancers', 'timeFrame': '5 and 10 years', 'description': 'Number of participants with cancers. Diagnostic information will be obtained from medical records review and service reimbursement data.'}, {'measure': 'Chronic obstructive pulmonary disease', 'timeFrame': '5 and 10 years', 'description': 'Number of participants with physician-diagnosed chronic obstructive pulmonary disease. Diagnostic information will be obtained from medical records review and service reimbursement data.'}, {'measure': 'Mortality', 'timeFrame': '5 and 10 years', 'description': 'All-cause mortality retrieved from death certificate database, which captures deaths nationwide, dates of death and related causes.'}, {'measure': 'Blood sugar', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Blood sugar assessed as fasting plasma glucose and glycated hemoglobin (HbA1c)'}, {'measure': 'Blood lipids', 'timeFrame': '1, 2, 5 and 10 years', 'description': 'Blood lipids include total, LDL- and HDL-cholesterol and triglyceride'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lifestyle modification', 'Primary prevention', 'Community-based intervention', 'Randomized control trial'], 'conditions': ['Dementia', 'Diabetes Mellitus', 'Chronic Kidney Disease', 'Cardiovascular Diseases', 'Malignancy', 'Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'This is a community-based cluster randomized control trial aimed to investigate the impact of lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive pulmonary disease and cardiovascular disease in an intermediate risk population in mixed urban-rural areas of Ubon Ratchathani.', 'detailedDescription': "This is a community-based cluster randomized control trial aimed to investigate the impact of lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive pulmonary disease and cardiovascular disease in an intermediate risk population in mixed urban-rural areas of Ubon Ratchathani.\n\nObjectives:\n\n1. examine the impact of lifestyle modification on the development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive pulmonary disease and cardiovascular disease in an intermediate risk population in Ubon Ratchathani\n2. examine the economic impact of lifestyle modification on prevention of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive pulmonary disease and cardiovascular disease in an intermediate risk population in Ubon Ratchathani\n\nStudy design: community-based cluster randomized control trial\n\nSetting: 60 villages randomly selected from mixed urban-rural areas in 15 districts of Ubon Ratchathani province.\n\nStudy population: 3,600 apparently healthy men and women aged 45-75 years who have resided in the village selected for at least one year. 4,000 men and women will be approached and screened.\n\nScreening and baseline assessment:\n\nAfter community consent, potential participants will be informed about the details of the project. For those who are willing to participate, written informed consent will be given before carrying out all research procedures. Participants will be questioned about their demographic characteristics, medical and family history, health behaviours including diet, physical activity, alcohol drinking and smoking. Physical activity will be assess using the Global Physical Activity Questionnaire (GPAQ) and diet will be assessed using 24 hour food recall. Their cognitive function will be assessed using the Mini-Mental State Exam (MMSE), Thai version, and clock drawing test and depression test will also be performed. Physical examination includes weight, height, blood pressure, waist and hip circumference as well as physical fitness test.\n\nFasting blood samples will be collected for the following laboratory tests: Complete blood count, creatinine, estimated glomerular filtration rate (eGFR), fasting plasma glucose, glycated haemoglobin (HbA1c), total cholesterol, triglyceride, HDL and estimated LDL-cholesterol, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), thyroid stimulating hormone (TSH), Ca++, PO4-, urine creatinine/albumin, urine sodium \\& potassium.\n\nInterventions:\n\nParticipants in 30 villages in the intervention group will be given 4x4 lifestyle modification intervention, which will address four health behaviors (diet, physical activity, alcohol drinking and smoking) at four different levels: individual, household, knowledge management and community levels. A new computer program called 'iActive' will be used. The program was adapted from the GPAQ with add-on functions to allow real-time assessment and presentation of the energy expenditure along with recommendations specific to each individual. Dietary counseling will be given individually following assessment using a new dietary assessment program called Dietary Assessment Scanning Calculator (DISC). Home visit will be done every 3 months by responsible nurses and village health volunteers in order to assess and give simple counseling about health behaviors. Knowledge management will be undertaken through meetings and forums between participants and villages with support from trained nurses. Situation analysis and agreed community action will be encouraged to address community problems concerning four health behaviors. A combination of these intensive interventions will be given for 3 years.\n\nFollow-up and outcome ascertainment:\n\nParticipants will be followed at 1, 2, 5 and 10 years after baseline assessment for the development of the outcomes of interest. In each follow-up, procedures identical to baseline assessment will be done.\n\nPrimary outcome: Incident dementia Incident dementia will be ascertained by a battery of screening test (MMSE, clock drawing and depression tests) and those with abnormal test results will be referred to neuro-medicine specialists at the regional hospital for further investigations and diagnosis.\n\nSecondary outcomes:\n\n1. Type 2 diabetes mellitus\n2. chronic kidney disease\n3. cancers\n4. chronic obstructive pulmonary disease\n5. cardiovascular disease\n6. body mass index\n7. waist circumference\n8. blood pressure\n9. Fasting plasma glucose\n10. HbA1c\n11. Lipids (total cholesterol, triglyceride, HDL and estimated LDL)\n\nTertiary outcomes:\n\n1. MMSE scores or Cognitive decline\n2. Alzheimer's disease\n3. Physical activity levels\n4. Dietary intake\n5. prevalence of current smokers\n6. prevalence of alcohol consumption"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Thai nationality\n* Age 45-75 years\n* Have resided in the Ubon Ratchathani's villages for at least 1 year\n* Those giving written informed consent to participate in the research project\n\nExclusion Criteria:\n\n* Known case of dementia, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, cancers and cardiovascular disease\n* Unable to communicate well in Thai\n* Unable to move or get physical exercise\n* Those at risk of having complications from performing physical exercise\n* Those diagnosed with cancers of any system/ organ or those in the end of life period"}, 'identificationModule': {'nctId': 'NCT02967406', 'briefTitle': 'Impact of Lifestyle Modification on the Development of Dementia, Chronic Kidney Disease, Diabetes, Chronic Obstructive Pulmonary Disease, Cancers and Cardiovascular Disease in a Thai General Population', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sanpasitthiprasong Hospital'}, 'officialTitle': 'Impact of Lifestyle Modification on Prevention of Dementia, Chronic Kidney Disease, Diabetes, Chronic Obstructive Pulmonary Disease, Cancers and Cardiovascular Disease in a Thai General Population: Cluster Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CMR-571'}, 'secondaryIdInfos': [{'id': 'HSRI 59-069', 'type': 'OTHER_GRANT', 'domain': 'Health System Research Institute'}, {'id': 'TCTR20161116001', 'type': 'REGISTRY', 'domain': 'Thai Clinical Trials Registry'}, {'id': '59-00-0228', 'type': 'OTHER_GRANT', 'domain': 'Thai Health Promotion Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle modification', 'description': '4 x 4 lifestyle modification intervention, addressing four health behaviors including physical activity, diet, smoking and alcohol drinking, at four different levels, i.e. individual, household, group/ knowledge management, and community levels', 'interventionNames': ['Behavioral: 4 x 4 lifestyle modification']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'No special intervention will be given. Prevention and treatment in normal practice is allowed'}], 'interventions': [{'name': '4 x 4 lifestyle modification', 'type': 'BEHAVIORAL', 'description': "Participants in the intervention group will be given 4x4 lifestyle modification intervention, which will address four health behaviors (diet, physical activity, alcohol drinking and smoking) at four different levels: individual, household, knowledge management and community levels. A new computer program called 'iActive' adapted from the GPAQ with add-on functions to allow real-time assessment and presentation of the energy expenditure along with recommendations specific to each individual will be used. Dietary counseling will be given individually following assessment using a new dietary assessment program called Dietary Assessment Scanning Calculator. Home visit will be done every 3 months by responsible nurses and village health volunteers. Knowledge management will be done through meetings between participants and villages with support from trained nurses. Situation analysis and community action will be encouraged to address four health behaviors.", 'armGroupLabels': ['Lifestyle modification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Muaeng', 'state': 'Changwat Ubon Ratchathani', 'country': 'Thailand', 'facility': 'Sanpasitthiprasong Hospital'}], 'overallOfficials': [{'name': 'Prasert Boongird, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dementia Association of Dementia'}, {'name': 'Parinya Chamnan, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sanpasitthiprasong Hospital'}, {'name': 'Wannee Nitiyanant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}, {'name': 'Wichai Aekplakorn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital, Mahidol University'}, {'name': 'Chanida Pachotikarn, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thai Dietetic Society'}, {'name': 'Chaicharn Deerochanawong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rajvithi Hospital'}, {'name': 'Surasak Kantachuvesiri, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital, Mahidol University'}, {'name': 'Wallaya Jongjaroenprasert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital, Mahidol University'}, {'name': 'Atiporn Ingsathit, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi Hospital, Mahidol University'}, {'name': 'Win Techakehakij, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lampang Hospital'}, {'name': 'Phanida Krittayapoositpot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dementia Association of Thailand'}, {'name': 'Worawan Chailimpamontri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bhumibol Adulyadej Hospital'}, {'name': 'Ampika Mangklabruks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Chiangmai University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanpasitthiprasong Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Dementia Association of Thailand', 'class': 'UNKNOWN'}, {'name': 'Diabetes Association of Thailand', 'class': 'UNKNOWN'}, {'name': 'The Endocrine Society of Thailand', 'class': 'OTHER'}, {'name': 'Nephrology Society of Thailand', 'class': 'UNKNOWN'}, {'name': 'Thai Dietetic Society', 'class': 'UNKNOWN'}, {'name': 'Ubon Ratchathani Public Health Office, Thailand', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'P Chamnan', 'investigatorAffiliation': 'Sanpasitthiprasong Hospital'}}}}