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

NCT ID: NCT02967406

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2027-08-31

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

Conditions

Dementia; Diabetes Mellitus; Chronic Kidney Disease; Cardiovascular Diseases; Malignancy; Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

4 x 4 lifestyle modification

Intervention Type: BEHAVIORAL

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.

Control

No special intervention will be given. Prevention and treatment in normal practice is allowed

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dementia Association of Thailand

UNKNOWN

Sponsor Role: collaborator

Diabetes Association of Thailand

UNKNOWN

Sponsor Role: collaborator

The Endocrine Society of Thailand

OTHER

Sponsor Role: collaborator

Nephrology Society of Thailand

UNKNOWN

Sponsor Role: collaborator

Thai Dietetic Society

UNKNOWN

Sponsor Role: collaborator

Ubon Ratchathani Public Health Office, Thailand

OTHER_GOV

Sponsor Role: collaborator

Sanpasitthiprasong Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

P Chamnan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Prasert Boongird, MD

Role: STUDY_DIRECTOR

Dementia Association of Dementia

Parinya Chamnan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sanpasitthiprasong Hospital

Wannee Nitiyanant, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Wichai Aekplakorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Mahidol University

Chanida Pachotikarn, PhD

Role: PRINCIPAL_INVESTIGATOR

Thai Dietetic Society

Chaicharn Deerochanawong, MD

Role: PRINCIPAL_INVESTIGATOR

Rajvithi Hospital

Surasak Kantachuvesiri, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Mahidol University

Wallaya Jongjaroenprasert, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Mahidol University

Atiporn Ingsathit, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Mahidol University

Win Techakehakij, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lampang Hospital

Phanida Krittayapoositpot, MD

Role: PRINCIPAL_INVESTIGATOR

Dementia Association of Thailand

Worawan Chailimpamontri, MD

Role: PRINCIPAL_INVESTIGATOR

Bhumibol Adulyadej Hospital

Ampika Mangklabruks, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Chiangmai University

Locations

Sanpasitthiprasong Hospital

Muaeng, Changwat Ubon Ratchathani, Thailand

Countries

Thailand

Other Identifiers

HSRI 59-069

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

TCTR20161116001

Identifier Type: REGISTRY

Identifier Source: secondary_id

59-00-0228

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CMR-571

Identifier Type: -

Identifier Source: org_study_id