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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.
Register: TCTR
Last refreshed on: 15 January 2019
Main ID:  TCTR20161116001
Date of registration: 17/02/2015
Prospective Registration: No
Primary sponsor: Health Systems Research Institute
Public title: Impact of lifestyle modification on the development of dementia, chronic kidney disease, diabetes and cardiovascular disease in a Thai general population
Scientific title: Impact of lifestyle modification on prevention of dementia, chronic kidney disease, diabetes and cardiovascular disease in a Thai general population: cluster randomized controlled trial
Date of first enrolment: 05/01/2015
Target sample size: 3600
Recruitment status: Recruiting
URL:  http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=fulltext&task=search&task2=view1&id=1312
Study type:  Interventional
Study design:  Randomized controlled trial  
Phase:  Phase 3
Countries of recruitment
Thailand
Contacts
Name: Parinya    Chamnan
Address:  Department of Social Medicine, Sanpasitthiprasong Hospital, Sappasit Road Ubon Ratchathani 34000 34000 Ubon Ratchathani Thailand
Telephone: 006645344972
Email: princdos04@gmail.com
Affiliation:  Department of Social Medicine, Sanpasitthiprasong Hospital
Name: Parinya    Chamnan
Address:  Sanpasitthiprasong Hospital, Sanpasit Road Ubon Ratchathani 34000 34000 Ubon Ratchathani Thailand
Telephone: 045244972
Email: princdos04@gmail.com
Affiliation:  Sanpasitthiprasong Hospital
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
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
Dementia
Chronic kidney disease stage 3
Type 2 diabetes mellitus
Cancers
COPD
Cardiovascular disease
Intervention(s)
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.
Primary Outcome(s)
incident dementia [Timeframe 10 years clinical diagnosis following a battery of screening tests]
Secondary Outcome(s)
incident cancer [Timeframe 10 years clinical diagnosis]
incident cardiovascular disease [Timeframe 5 and 10 years clinical diagnosis using data from medical records]
incident chronic kidney disease stage 3 [Timeframe 5 and 10 years biochemical diagnosis]
Incident COPD [Timeframe 5 and 10 years clinical diagnosis using data from medical records]
incident diabetes [Timeframe 3, 5 and 10 years biochemical diagnosis]
Secondary ID(s)
IHSR 57-119 and IHSR
Source(s) of Monetary Support
Health Systems Research Institute
Secondary Sponsor(s)
�National Research Council of Thailand
Thai Health Promotion Foundation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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