Clinical trial NCT02967406: 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
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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dementia
Diabetes Mellitus
Chronic Kidney Disease
Cardiovascular Diseases
Malignancy
Chronic Obstructive Pulmonary Disease
Keywords: Lifestyle modification
Primary prevention
Community-based intervention
Randomized control trial
Lead sponsor: Sanpasitthiprasong Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Dementia Association of Thailand
name: Diabetes Association of Thailand
name: The Endocrine Society of Thailand
name: Nephrology Society of Thailand
name: Thai Dietetic Society
name: Ubon Ratchathani Public Health Office, Thailand
First posted: 2016-11-18
Enrollment: 3600
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: 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

Eligibility 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

Primary outcomes:
measure: Dementia
timeFrame: 10 years
Secondary outcomes:
measure: Type 2 diabetes mellitus
timeFrame: 3, 5 and 10 years
measure: Cardiovascular disease
timeFrame: 5 and 10 years
measure: Cancers
timeFrame: 5 and 10 years
measure: Chronic obstructive pulmonary disease
timeFrame: 5 and 10 years
measure: Mortality
timeFrame: 5 and 10 years
measure: Blood sugar
timeFrame: 1, 2, 5 and 10 years
measure: Blood lipids
timeFrame: 1, 2, 5 and 10 years
Other outcomes:
measure: Physical activity levels
timeFrame: 1, 2, 5 and 10 years
measure: Diet
timeFrame: 1, 2, 5 and 10 years
measure: Prevalence of current smokers
timeFrame: 1, 2, 5 and 10 years
measure: Prevalence of alcohol consumption
timeFrame: 1, 2, 5 and 10 years
measure: Cognitive function
timeFrame: 2, 5 and 10 years
Locations:
city: Muaeng
country: Thailand
facility: Sanpasitthiprasong Hospital
state: Ubon Ratchathani
Study officials:
affiliation: Dementia Association of Dementia
name: Prasert Boongird, MD
role: STUDY_DIRECTOR
affiliation: Sanpasitthiprasong Hospital
name: Parinya Chamnan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Siriraj Hospital
name: Wannee Nitiyanant, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ramathibodi Hospital, Mahidol University
name: Wichai Aekplakorn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thai Dietetic Society
name: Chanida Pachotikarn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rajvithi Hospital
name: Chaicharn Deerochanawong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ramathibodi Hospital, Mahidol University
name: Surasak Kantachuvesiri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ramathibodi Hospital, Mahidol University
name: Wallaya Jongjaroenprasert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ramathibodi Hospital, Mahidol University
name: Atiporn Ingsathit, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lampang Hospital
name: Win Techakehakij, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dementia Association of Thailand
name: Phanida Krittayapoositpot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bhumibol Adulyadej Hospital
name: Worawan Chailimpamontri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Chiangmai University
name: Ampika Mangklabruks, MD
role: PRINCIPAL_INVESTIGATOR
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