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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
Sponsor:
Collaborators:
Dementia Association of Thailand
Diabetes Association of Thailand
The Endocrine Society of Thailand
Nephrology Society of Thailand
Thai Dietetic Society
Ubon Ratchathani Public Health Office, Thailand
Information provided by (Responsible Party):
P Chamnan, Sanpasitthiprasong Hospital

Brief Summary:
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Blood sugar [ Time Frame: 1, 2, 5 and 10 years ]
    Blood sugar assessed as fasting plasma glucose and glycated hemoglobin (HbA1c)

  7. Blood lipids [ Time Frame: 1, 2, 5 and 10 years ]
    Blood lipids include total, LDL- and HDL-cholesterol and triglyceride


Other Outcome Measures:
  1. Physical activity levels [ Time Frame: 1, 2, 5 and 10 years ]
    Physical activity levels assessed using the global physical activity questionnaire (GPAQ)

  2. Diet [ Time Frame: 1, 2, 5 and 10 years ]
    Diet assessed by 24 hour food recall

  3. Prevalence of current smokers [ Time Frame: 1, 2, 5 and 10 years ]
    Percentage of current smokers in the study samples

  4. Prevalence of alcohol consumption [ Time Frame: 1, 2, 5 and 10 years ]
    Percentage of those who report alcohol consumption

  5. Cognitive function [ Time Frame: 2, 5 and 10 years ]
    Cognitive function assessed by MMSE score



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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Thai nationality
  • Age 45-75 years
  • Have resided in the Ubon Ratchathani's villages for at least 1 year
  • Those giving written informed consent to participate in the research project

Exclusion Criteria:

  • Known case of dementia, chronic kidney disease, diabetes, chronic obstructive pulmonary disease, cancers and cardiovascular disease
  • Unable to communicate well in Thai
  • Unable to move or get physical exercise
  • Those at risk of having complications from performing physical exercise
  • Those diagnosed with cancers of any system/ organ or those in the end of life period

Information from the National Library of Medicine

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


Locations
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Thailand
Sanpasitthiprasong Hospital
Muaeng, Ubon Ratchathani, Thailand, 34000
Sponsors and Collaborators
Sanpasitthiprasong Hospital
Dementia Association of Thailand
Diabetes Association of Thailand
The Endocrine Society of Thailand
Nephrology Society of Thailand
Thai Dietetic Society
Ubon Ratchathani Public Health Office, Thailand
Investigators
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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

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Responsible Party: P Chamnan, Principal Investigator, Sanpasitthiprasong Hospital
ClinicalTrials.gov Identifier: NCT02967406     History of Changes
Other Study ID Numbers: CMR-571
HSRI 59-069 ( Other Grant/Funding Number: Health System Research Institute )
TCTR20161116001 ( Registry Identifier: Thai Clinical Trials Registry )
59-00-0228 ( Other Grant/Funding Number: Thai Health Promotion Foundation )
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

Keywords provided by P Chamnan, Sanpasitthiprasong Hospital:
Lifestyle modification
Primary prevention
Community-based intervention
Randomized control trial

Additional relevant MeSH terms:
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Diabetes Mellitus
Lung Diseases
Cardiovascular Diseases
Kidney Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Renal Insufficiency, Chronic
Dementia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Respiratory Tract Diseases
Urologic Diseases
Renal Insufficiency
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders