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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02967406
• Other study ID #: CMR-571
• Secondary ID: HSRI 59-069TCTR2
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: May 30, 2017
• Start date: March 2016
• Est. completion date: August 2027

Study information

• Verified date: May 2017
• Source: Sanpasitthiprasong Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3600
• Est. completion date: August 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chronic Kidney Disease
• Chronic Obstructive Pulmonary Disease
• Dementia
• Diabetes Mellitus
• Kidney Diseases
• Lung Diseases
• Lung Diseases, Obstructive
• Malignancy
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Thailand	Sanpasitthiprasong Hospital	Muaeng	Ubon Ratchathani

Sponsors (7)

Lead Sponsor	Collaborator
Sanpasitthiprasong Hospital	Dementia Association of Thailand, Diabetes Association of Thailand, Nephrology Society of Thailand, Thai Dietetic Society, The Endocrine Society of Thailand, Ubon Ratchathani Public Health Office, Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physical activity levels	Physical activity levels assessed using the global physical activity questionnaire (GPAQ)	1, 2, 5 and 10 years
Other	Diet	Diet assessed by 24 hour food recall	1, 2, 5 and 10 years
Other	Prevalence of current smokers	Percentage of current smokers in the study samples	1, 2, 5 and 10 years
Other	Prevalence of alcohol consumption	Percentage of those who report alcohol consumption	1, 2, 5 and 10 years
Other	Cognitive function	Cognitive function assessed by MMSE score	2, 5 and 10 years
Primary	Dementia	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.	10 years
Secondary	Type 2 diabetes mellitus	Number of participants with type 2 diabetes mellitus. Diabetes mellitus is biochemically and clinically diagnosed.	3, 5 and 10 years
Secondary	Cardiovascular disease	Number of participants with cardiovascular disease. Clinical diagnosis of cardiovascular disease. Diagnostic information will be obtained from medical records review and service reimbursement data.	5 and 10 years
Secondary	Cancers	Number of participants with cancers. Diagnostic information will be obtained from medical records review and service reimbursement data.	5 and 10 years
Secondary	Chronic obstructive pulmonary disease	Number of participants with physician-diagnosed chronic obstructive pulmonary disease. Diagnostic information will be obtained from medical records review and service reimbursement data.	5 and 10 years
Secondary	Mortality	All-cause mortality retrieved from death certificate database, which captures deaths nationwide, dates of death and related causes.	5 and 10 years
Secondary	Blood sugar	Blood sugar assessed as fasting plasma glucose and glycated hemoglobin (HbA1c)	1, 2, 5 and 10 years
Secondary	Blood lipids	Blood lipids include total, LDL- and HDL-cholesterol and triglyceride	1, 2, 5 and 10 years