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

NCT02967406 | Active Not Recruiting DMC

• 4 other identifiers: CMR-571HSRI 59-069TCTR2016111600159-00-0228
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Type 2 diabetes mellitus

  3, 5 and 10 years

• Cardiovascular disease

  5 and 10 years

• Cancers

  5 and 10 years

• Chronic obstructive pulmonary disease

  5 and 10 years

• Mortality

  5 and 10 years

Other Outcomes (5)

• Physical activity levels

  1, 2, 5 and 10 years

• Diet

  1, 2, 5 and 10 years

• Prevalence of current smokers

  1, 2, 5 and 10 years

Study Arms (2)

Lifestyle modification

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

4 x 4 lifestyle modification 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.

Lifestyle modification

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanpasitthiprasong Hospital: lead
• Dementia Association of Thailand: collaborator
• Diabetes Association of Thailand: collaborator
• The Endocrine Society of Thailand: collaborator
• Nephrology Society of Thailand: collaborator
• Thai Dietetic Society: collaborator
• Ubon Ratchathani Public Health Office, Thailand: collaborator

Study Sites (1)

Sanpasitthiprasong Hospital

Muaeng, Changwat Ubon Ratchathani, 34000, Thailand

Location

MeSH Terms

Conditions

Dementia; Diabetes Mellitus; Renal Insufficiency, Chronic; Cardiovascular Diseases; Neoplasms; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Prasert Boongird, MD

  Dementia Association of Dementia

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2016
• First Posted: November 18, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

TH (1)