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
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|ClinicalTrials.gov Identifier: NCT02967406|
Recruitment Status : Active, not recruiting
First Posted : November 18, 2016
Last Update Posted : May 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dementia Diabetes Mellitus Chronic Kidney Disease Cardiovascular Diseases Malignancy Chronic Obstructive Pulmonary Disease||Behavioral: 4 x 4 lifestyle modification||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||March 2027|
|Estimated Study Completion Date :||August 2027|
Experimental: Lifestyle modification
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
Behavioral: 4 x 4 lifestyle modification
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.
No Intervention: Control
No special intervention will be given. Prevention and treatment in normal practice is allowed
- Dementia [ Time Frame: 10 years ]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.
- Type 2 diabetes mellitus [ Time Frame: 3, 5 and 10 years ]Number of participants with type 2 diabetes mellitus. Diabetes mellitus is biochemically and clinically diagnosed.
- Cardiovascular disease [ Time Frame: 5 and 10 years ]Number of participants with cardiovascular disease. Clinical diagnosis of cardiovascular disease. Diagnostic information will be obtained from medical records review and service reimbursement data.
- Cancers [ Time Frame: 5 and 10 years ]Number of participants with cancers. Diagnostic information will be obtained from medical records review and service reimbursement data.
- Chronic obstructive pulmonary disease [ Time Frame: 5 and 10 years ]Number of participants with physician-diagnosed chronic obstructive pulmonary disease. Diagnostic information will be obtained from medical records review and service reimbursement data.
- Mortality [ Time Frame: 5 and 10 years ]All-cause mortality retrieved from death certificate database, which captures deaths nationwide, dates of death and related causes.
- Blood sugar [ Time Frame: 1, 2, 5 and 10 years ]Blood sugar assessed as fasting plasma glucose and glycated hemoglobin (HbA1c)
- Blood lipids [ Time Frame: 1, 2, 5 and 10 years ]Blood lipids include total, LDL- and HDL-cholesterol and triglyceride
- Physical activity levels [ Time Frame: 1, 2, 5 and 10 years ]Physical activity levels assessed using the global physical activity questionnaire (GPAQ)
- Diet [ Time Frame: 1, 2, 5 and 10 years ]Diet assessed by 24 hour food recall
- Prevalence of current smokers [ Time Frame: 1, 2, 5 and 10 years ]Percentage of current smokers in the study samples
- Prevalence of alcohol consumption [ Time Frame: 1, 2, 5 and 10 years ]Percentage of those who report alcohol consumption
- Cognitive function [ Time Frame: 2, 5 and 10 years ]Cognitive function assessed by MMSE score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967406
|Muaeng, Ubon Ratchathani, Thailand, 34000|
|Study Director:||Prasert Boongird, MD||Dementia Association of Dementia|
|Principal Investigator:||Parinya Chamnan, MD, PhD||Sanpasitthiprasong Hospital|
|Principal Investigator:||Wannee Nitiyanant, MD||Siriraj Hospital|
|Principal Investigator:||Wichai Aekplakorn, MD, PhD||Ramathibodi Hospital, Mahidol University|
|Principal Investigator:||Chanida Pachotikarn, PhD||Thai Dietetic Society|
|Principal Investigator:||Chaicharn Deerochanawong, MD||Rajvithi Hospital|
|Principal Investigator:||Surasak Kantachuvesiri, MD, PhD||Ramathibodi Hospital, Mahidol University|
|Principal Investigator:||Wallaya Jongjaroenprasert, MD||Ramathibodi Hospital, Mahidol University|
|Principal Investigator:||Atiporn Ingsathit, MD, PhD||Ramathibodi Hospital, Mahidol University|
|Principal Investigator:||Win Techakehakij, MD, PhD||Lampang Hospital|
|Principal Investigator:||Phanida Krittayapoositpot, MD||Dementia Association of Thailand|
|Principal Investigator:||Worawan Chailimpamontri, MD||Bhumibol Adulyadej Hospital|
|Principal Investigator:||Ampika Mangklabruks, MD||Faculty of Medicine, Chiangmai University|