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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20161116001 |
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Date of registration:
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16/11/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of lifestyle modification on the development of dementia, chronic kidney disease, diabetes and cardiovascular disease in a Thai general population
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Scientific title:
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Impact of lifestyle modification on prevention of dementia, chronic kidney disease, diabetes and cardiovascular disease in a Thai general population: cluster randomized controlled trial |
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Date of first enrolment:
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05/01/2015 |
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Target sample size:
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Recruitment status: |
Recruiting |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20161116001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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Phase 3
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Contacts
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Name:
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Parinya
Chamnan |
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Address:
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Department of Social Medicine, Sanpasitthiprasong Hospital, Sappasit Road
34000
Ubon Ratchathani
Thailand |
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Telephone:
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006645344972 |
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Email:
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princdos04@gmail.com |
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Affiliation:
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Department of Social Medicine, Sanpasitthiprasong Hospital |
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Name:
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Parinya
Chamnan |
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Address:
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Sanpasitthiprasong Hospital, Sanpasit Road
34000
Ubon Ratchathani
Thailand |
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Telephone:
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045244972 |
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Email:
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princdos04@gmail.com |
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Affiliation:
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Sanpasitthiprasong Hospital |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Thai nationality
2. Age 45-75 years
3. Have resided in the Ubon Ratchathani's villages for at least 1 year
4. giving written informed consent to participate in the research project
Exclusion criteria: 1. Known cases of dementia, chronic kidney disease, diabetes, COPD, cancers and cardiovascular disease
2. Unable to communicate well in Thai
3. Unable to move or get physical exercise
4. Those at risk of having complications from performing physical exercise
5. Those diagnosed with cancers of any system/ organ or those in the end of life period
Age minimum:
45 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dementia
Chronic kidney disease stage 3
Type 2 diabetes mellitus
Cancers
COPD
Cardiovascular disease
Dementia
Chronic kidney disease stage 3
Type 2 diabetes mellitus
Cancers
COPD
Cardiovascular disease
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Dementia
Chronic kidney disease stage 3
Type 2 diabetes mellitus
Cancers
COPD
Cardiovascular disease
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Intervention(s)
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4 x 4 lifestyle modification intervention,controls
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4 x 4 lifestyle modification intervention, addressing 4 healthy behaviors including physical activity, diet, smoking and alcohol drinking, at 4 different levels, i.e. individual, household, group/ knowledge management, and community levels ,No special intervention will be given. Prevention and treatment in normal practice is allowed.
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Experimental Behavioral,No Intervention No treatment
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Primary Outcome(s)
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incident dementia 10 years clinical diagnosis following a battery of screening tests
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Secondary Outcome(s)
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incident diabetes 3, 5 and 10 years biochemical diagnosis,incident chronic kidney disease stage 3 5 and 10 years biochemical diagnosis,incident cardiovascular disease 5 and 10 years clinical diagnosis using data from medical records,incident cancer 10 years clinical diagnosis,Incident COPD 5 and 10 years clinical diagnosis using data from medical records
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Secondary ID(s)
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IHSR 57-119 and IHSR
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Source(s) of Monetary Support
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Health Systems Research Institute
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
Ethical Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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16/11/2025 |
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URL:
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