<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02967406</url>
  </required_header>
  <id_info>
    <org_study_id>CMR-571</org_study_id>
    <secondary_id>HSRI 59-069</secondary_id>
    <secondary_id>TCTR20161116001</secondary_id>
    <secondary_id>59-00-0228</secondary_id>
    <nct_id>NCT02967406</nct_id>
  </id_info>
  <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</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanpasitthiprasong Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dementia Association of Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Diabetes Association of Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Endocrine Society of Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nephrology Society of Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Thai Dietetic Society</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ubon Ratchathani Public Health Office, Thailand</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sanpasitthiprasong Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a community-based cluster randomized control trial aimed to investigate the impact of&#xD;
      lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the&#xD;
      development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive&#xD;
      pulmonary disease and cardiovascular disease in an intermediate risk population in mixed&#xD;
      urban-rural areas of Ubon Ratchathani.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a community-based cluster randomized control trial aimed to investigate the impact of&#xD;
      lifestyle modification (diet, physical activity, alcohol drinking and smoking) on the&#xD;
      development of dementia, diabetes, chronic kidney disease, cancers, chronic obstructive&#xD;
      pulmonary disease and cardiovascular disease in an intermediate risk population in mixed&#xD;
      urban-rural areas of Ubon Ratchathani.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. examine the impact of lifestyle modification on the development of dementia, diabetes,&#xD;
           chronic kidney disease, cancers, chronic obstructive pulmonary disease and&#xD;
           cardiovascular disease in an intermediate risk population in Ubon Ratchathani&#xD;
&#xD;
        2. examine the economic impact of lifestyle modification on prevention of dementia,&#xD;
           diabetes, chronic kidney disease, cancers, chronic obstructive pulmonary disease and&#xD;
           cardiovascular disease in an intermediate risk population in Ubon Ratchathani&#xD;
&#xD;
      Study design: community-based cluster randomized control trial&#xD;
&#xD;
      Setting: 60 villages randomly selected from mixed urban-rural areas in 15 districts of Ubon&#xD;
      Ratchathani province.&#xD;
&#xD;
      Study population: 3,600 apparently healthy men and women aged 45-75 years who have resided in&#xD;
      the village selected for at least one year. 4,000 men and women will be approached and&#xD;
      screened.&#xD;
&#xD;
      Screening and baseline assessment:&#xD;
&#xD;
      After community consent, potential participants will be informed about the details of the&#xD;
      project. For those who are willing to participate, written informed consent will be given&#xD;
      before carrying out all research procedures. Participants will be questioned about their&#xD;
      demographic characteristics, medical and family history, health behaviours including diet,&#xD;
      physical activity, alcohol drinking and smoking. Physical activity will be assess using the&#xD;
      Global Physical Activity Questionnaire (GPAQ) and diet will be assessed using 24 hour food&#xD;
      recall. Their cognitive function will be assessed using the Mini-Mental State Exam (MMSE),&#xD;
      Thai version, and clock drawing test and depression test will also be performed. Physical&#xD;
      examination includes weight, height, blood pressure, waist and hip circumference as well as&#xD;
      physical fitness test.&#xD;
&#xD;
      Fasting blood samples will be collected for the following laboratory tests: Complete blood&#xD;
      count, creatinine, estimated glomerular filtration rate (eGFR), fasting plasma glucose,&#xD;
      glycated haemoglobin (HbA1c), total cholesterol, triglyceride, HDL and estimated&#xD;
      LDL-cholesterol, serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic&#xD;
      transaminase (SGPT), thyroid stimulating hormone (TSH), Ca++, PO4-, urine creatinine/albumin,&#xD;
      urine sodium &amp; potassium.&#xD;
&#xD;
      Interventions:&#xD;
&#xD;
      Participants in 30 villages in the intervention group will be given 4x4 lifestyle&#xD;
      modification intervention, which will address four health behaviors (diet, physical activity,&#xD;
      alcohol drinking and smoking) at four different levels: individual, household, knowledge&#xD;
      management and community levels. A new computer program called 'iActive' will be used. The&#xD;
      program was adapted from the GPAQ with add-on functions to allow real-time assessment and&#xD;
      presentation of the energy expenditure along with recommendations specific to each&#xD;
      individual. Dietary counseling will be given individually following assessment using a new&#xD;
      dietary assessment program called Dietary Assessment Scanning Calculator (DISC). Home visit&#xD;
      will be done every 3 months by responsible nurses and village health volunteers in order to&#xD;
      assess and give simple counseling about health behaviors. Knowledge management will be&#xD;
      undertaken through meetings and forums between participants and villages with support from&#xD;
      trained nurses. Situation analysis and agreed community action will be encouraged to address&#xD;
      community problems concerning four health behaviors. A combination of these intensive&#xD;
      interventions will be given for 3 years.&#xD;
&#xD;
      Follow-up and outcome ascertainment:&#xD;
&#xD;
      Participants will be followed at 1, 2, 5 and 10 years after baseline assessment for the&#xD;
      development of the outcomes of interest. In each follow-up, procedures identical to baseline&#xD;
      assessment will be done.&#xD;
&#xD;
      Primary outcome: Incident dementia Incident dementia will be ascertained by a battery of&#xD;
      screening test (MMSE, clock drawing and depression tests) and those with abnormal test&#xD;
      results will be referred to neuro-medicine specialists at the regional hospital for further&#xD;
      investigations and diagnosis.&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
        1. Type 2 diabetes mellitus&#xD;
&#xD;
        2. chronic kidney disease&#xD;
&#xD;
        3. cancers&#xD;
&#xD;
        4. chronic obstructive pulmonary disease&#xD;
&#xD;
        5. cardiovascular disease&#xD;
&#xD;
        6. body mass index&#xD;
&#xD;
        7. waist circumference&#xD;
&#xD;
        8. blood pressure&#xD;
&#xD;
        9. Fasting plasma glucose&#xD;
&#xD;
       10. HbA1c&#xD;
&#xD;
       11. Lipids (total cholesterol, triglyceride, HDL and estimated LDL)&#xD;
&#xD;
      Tertiary outcomes:&#xD;
&#xD;
        1. MMSE scores or Cognitive decline&#xD;
&#xD;
        2. Alzheimer's disease&#xD;
&#xD;
        3. Physical activity levels&#xD;
&#xD;
        4. Dietary intake&#xD;
&#xD;
        5. prevalence of current smokers&#xD;
&#xD;
        6. prevalence of alcohol consumption&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">August 2027</completion_date>
  <primary_completion_date type="Anticipated">March 2027</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dementia</measure>
    <time_frame>10 years</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type 2 diabetes mellitus</measure>
    <time_frame>3, 5 and 10 years</time_frame>
    <description>Number of participants with type 2 diabetes mellitus. Diabetes mellitus is biochemically and clinically diagnosed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular disease</measure>
    <time_frame>5 and 10 years</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancers</measure>
    <time_frame>5 and 10 years</time_frame>
    <description>Number of participants with cancers. Diagnostic information will be obtained from medical records review and service reimbursement data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic obstructive pulmonary disease</measure>
    <time_frame>5 and 10 years</time_frame>
    <description>Number of participants with physician-diagnosed chronic obstructive pulmonary disease. Diagnostic information will be obtained from medical records review and service reimbursement data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>5 and 10 years</time_frame>
    <description>All-cause mortality retrieved from death certificate database, which captures deaths nationwide, dates of death and related causes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood sugar</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
    <description>Blood sugar assessed as fasting plasma glucose and glycated hemoglobin (HbA1c)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood lipids</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
    <description>Blood lipids include total, LDL- and HDL-cholesterol and triglyceride</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical activity levels</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
    <description>Physical activity levels assessed using the global physical activity questionnaire (GPAQ)</description>
  </other_outcome>
  <other_outcome>
    <measure>Diet</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
    <description>Diet assessed by 24 hour food recall</description>
  </other_outcome>
  <other_outcome>
    <measure>Prevalence of current smokers</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
    <description>Percentage of current smokers in the study samples</description>
  </other_outcome>
  <other_outcome>
    <measure>Prevalence of alcohol consumption</measure>
    <time_frame>1, 2, 5 and 10 years</time_frame>
    <description>Percentage of those who report alcohol consumption</description>
  </other_outcome>
  <other_outcome>
    <measure>Cognitive function</measure>
    <time_frame>2, 5 and 10 years</time_frame>
    <description>Cognitive function assessed by MMSE score</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">3600</enrollment>
  <condition>Dementia</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Chronic Kidney Disease</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Malignancy</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Lifestyle modification</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No special intervention will be given. Prevention and treatment in normal practice is allowed</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>4 x 4 lifestyle modification</intervention_name>
    <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.</description>
    <arm_group_label>Lifestyle modification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Thai nationality&#xD;
&#xD;
          -  Age 45-75 years&#xD;
&#xD;
          -  Have resided in the Ubon Ratchathani's villages for at least 1 year&#xD;
&#xD;
          -  Those giving written informed consent to participate in the research project&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known case of dementia, chronic kidney disease, diabetes, chronic obstructive&#xD;
             pulmonary disease, cancers and cardiovascular disease&#xD;
&#xD;
          -  Unable to communicate well in Thai&#xD;
&#xD;
          -  Unable to move or get physical exercise&#xD;
&#xD;
          -  Those at risk of having complications from performing physical exercise&#xD;
&#xD;
          -  Those diagnosed with cancers of any system/ organ or those in the end of life period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prasert Boongird, MD</last_name>
    <role>Study Director</role>
    <affiliation>Dementia Association of Dementia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Parinya Chamnan, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanpasitthiprasong Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wannee Nitiyanant, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Siriraj Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wichai Aekplakorn, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chanida Pachotikarn, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Thai Dietetic Society</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chaicharn Deerochanawong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rajvithi Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Surasak Kantachuvesiri, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wallaya Jongjaroenprasert, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Atiporn Ingsathit, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ramathibodi Hospital, Mahidol University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Win Techakehakij, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lampang Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Phanida Krittayapoositpot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dementia Association of Thailand</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Worawan Chailimpamontri, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bhumibol Adulyadej Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ampika Mangklabruks, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Chiangmai University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanpasitthiprasong Hospital</name>
      <address>
        <city>Muaeng</city>
        <state>Ubon Ratchathani</state>
        <zip>34000</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sanpasitthiprasong Hospital</investigator_affiliation>
    <investigator_full_name>P Chamnan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lifestyle modification</keyword>
  <keyword>Primary prevention</keyword>
  <keyword>Community-based intervention</keyword>
  <keyword>Randomized control trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02967406
org study id: CMR-571
secondary id: HSRI 59-069
secondary id: TCTR20161116001
secondary id: 59-00-0228
nct id: NCT02967406
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
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.
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.

      Objectives:

        1. 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

        2. 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

      Study design: community-based cluster randomized control trial

      Setting: 60 villages randomly selected from mixed urban-rural areas in 15 districts of Ubon
      Ratchathani province.

      Study 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.

      Screening and baseline assessment:

      After 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.

      Fasting 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.

      Interventions:

      Participants 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.

      Follow-up and outcome ascertainment:

      Participants 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.

      Primary 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.

      Secondary outcomes:

        1. Type 2 diabetes mellitus

        2. chronic kidney disease

        3. cancers

        4. chronic obstructive pulmonary disease

        5. cardiovascular disease

        6. body mass index

        7. waist circumference

        8. blood pressure

        9. Fasting plasma glucose

       10. HbA1c

       11. Lipids (total cholesterol, triglyceride, HDL and estimated LDL)

      Tertiary outcomes:

        1. MMSE scores or Cognitive decline

        2. Alzheimer's disease

        3. Physical activity levels

        4. Dietary intake

        5. prevalence of current smokers

        6. prevalence of alcohol consumption
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Dementia
time frame: 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.
measure: Type 2 diabetes mellitus
time frame: 3, 5 and 10 years
description: Number of participants with type 2 diabetes mellitus. Diabetes mellitus is biochemically and clinically diagnosed.
measure: Cardiovascular disease
time frame: 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
time frame: 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
time frame: 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
time frame: 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
time frame: 1, 2, 5 and 10 years
description: Blood sugar assessed as fasting plasma glucose and glycated hemoglobin (HbA1c)
measure: Blood lipids
time frame: 1, 2, 5 and 10 years
description: Blood lipids include total, LDL- and HDL-cholesterol and triglyceride
measure: Physical activity levels
time frame: 1, 2, 5 and 10 years
description: Physical activity levels assessed using the global physical activity questionnaire (GPAQ)
measure: Diet
time frame: 1, 2, 5 and 10 years
description: Diet assessed by 24 hour food recall
measure: Prevalence of current smokers
time frame: 1, 2, 5 and 10 years
description: Percentage of current smokers in the study samples
measure: Prevalence of alcohol consumption
time frame: 1, 2, 5 and 10 years
description: Percentage of those who report alcohol consumption
measure: Cognitive function
time frame: 2, 5 and 10 years
description: Cognitive function assessed by MMSE score
arm group label: Lifestyle modification
arm group type: Experimental
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
arm group label: Control
arm group type: No Intervention
description: No special intervention will be given. Prevention and treatment in normal practice is allowed
intervention type: Behavioral
intervention name: 4 x 4 lifestyle modification
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.
arm group label: Lifestyle modification
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Prasert Boongird, MD
role: Study Director
affiliation: Dementia Association of Dementia
last name: Parinya Chamnan, MD, PhD
role: Principal Investigator
affiliation: Sanpasitthiprasong Hospital
last name: Wannee Nitiyanant, MD
role: Principal Investigator
affiliation: Siriraj Hospital
last name: Wichai Aekplakorn, MD, PhD
role: Principal Investigator
affiliation: Ramathibodi Hospital, Mahidol University
last name: Chanida Pachotikarn, PhD
role: Principal Investigator
affiliation: Thai Dietetic Society
last name: Chaicharn Deerochanawong, MD
role: Principal Investigator
affiliation: Rajvithi Hospital
last name: Surasak Kantachuvesiri, MD, PhD
role: Principal Investigator
affiliation: Ramathibodi Hospital, Mahidol University
last name: Wallaya Jongjaroenprasert, MD
role: Principal Investigator
affiliation: Ramathibodi Hospital, Mahidol University
last name: Atiporn Ingsathit, MD, PhD
role: Principal Investigator
affiliation: Ramathibodi Hospital, Mahidol University
last name: Win Techakehakij, MD, PhD
role: Principal Investigator
affiliation: Lampang Hospital
last name: Phanida Krittayapoositpot, MD
role: Principal Investigator
affiliation: Dementia Association of Thailand
last name: Worawan Chailimpamontri, MD
role: Principal Investigator
affiliation: Bhumibol Adulyadej Hospital
last name: Ampika Mangklabruks, MD
role: Principal Investigator
affiliation: Faculty of Medicine, Chiangmai University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Sanpasitthiprasong Hospital
investigator full name: P Chamnan
investigator title: Principal Investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Dementia
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Cardiovascular Diseases
mesh term: Diabetes Mellitus