- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
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
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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:
- 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
- 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:
- Type 2 diabetes mellitus
- chronic kidney disease
- cancers
- chronic obstructive pulmonary disease
- cardiovascular disease
- body mass index
- waist circumference
- blood pressure
- Fasting plasma glucose
- HbA1c
- Lipids (total cholesterol, triglyceride, HDL and estimated LDL)
Tertiary outcomes:
- MMSE scores or Cognitive decline
- Alzheimer's disease
- Physical activity levels
- Dietary intake
- prevalence of current smokers
- prevalence of alcohol consumption
Typ studie
Zápis (Očekávaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Ubon Ratchathani
-
Muaeng, Ubon Ratchathani, Thajsko, 34000
- Sanpasitthiprasong Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: 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
|
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.
|
Žádný zásah: Control
No special intervention will be given.
Prevention and treatment in normal practice is allowed
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Dementia
Časové okno: 10 years
|
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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Type 2 diabetes mellitus
Časové okno: 3, 5 and 10 years
|
Number of participants with type 2 diabetes mellitus.
Diabetes mellitus is biochemically and clinically diagnosed.
|
3, 5 and 10 years
|
Cardiovascular disease
Časové okno: 5 and 10 years
|
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
|
Cancers
Časové okno: 5 and 10 years
|
Number of participants with cancers.
Diagnostic information will be obtained from medical records review and service reimbursement data.
|
5 and 10 years
|
Chronic obstructive pulmonary disease
Časové okno: 5 and 10 years
|
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
|
Mortality
Časové okno: 5 and 10 years
|
All-cause mortality retrieved from death certificate database, which captures deaths nationwide, dates of death and related causes.
|
5 and 10 years
|
Blood sugar
Časové okno: 1, 2, 5 and 10 years
|
Blood sugar assessed as fasting plasma glucose and glycated hemoglobin (HbA1c)
|
1, 2, 5 and 10 years
|
Blood lipids
Časové okno: 1, 2, 5 and 10 years
|
Blood lipids include total, LDL- and HDL-cholesterol and triglyceride
|
1, 2, 5 and 10 years
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Physical activity levels
Časové okno: 1, 2, 5 and 10 years
|
Physical activity levels assessed using the global physical activity questionnaire (GPAQ)
|
1, 2, 5 and 10 years
|
Diet
Časové okno: 1, 2, 5 and 10 years
|
Diet assessed by 24 hour food recall
|
1, 2, 5 and 10 years
|
Prevalence of current smokers
Časové okno: 1, 2, 5 and 10 years
|
Percentage of current smokers in the study samples
|
1, 2, 5 and 10 years
|
Prevalence of alcohol consumption
Časové okno: 1, 2, 5 and 10 years
|
Percentage of those who report alcohol consumption
|
1, 2, 5 and 10 years
|
Cognitive function
Časové okno: 2, 5 and 10 years
|
Cognitive function assessed by MMSE score
|
2, 5 and 10 years
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Prasert Boongird, MD, Dementia Association of Dementia
- Vrchní vyšetřovatel: Parinya Chamnan, MD, PhD, Sanpasitthiprasong Hospital
- Vrchní vyšetřovatel: Wannee Nitiyanant, MD, Siriraj Hospital
- Vrchní vyšetřovatel: Wichai Aekplakorn, MD, PhD, Ramathibodi Hospital, Mahidol University
- Vrchní vyšetřovatel: Chanida Pachotikarn, PhD, Thai Dietetic Society
- Vrchní vyšetřovatel: Chaicharn Deerochanawong, MD, Rajvithi Hospital
- Vrchní vyšetřovatel: Surasak Kantachuvesiri, MD, PhD, Ramathibodi Hospital, Mahidol University
- Vrchní vyšetřovatel: Wallaya Jongjaroenprasert, MD, Ramathibodi Hospital, Mahidol University
- Vrchní vyšetřovatel: Atiporn Ingsathit, MD, PhD, Ramathibodi Hospital, Mahidol University
- Vrchní vyšetřovatel: Win Techakehakij, MD, PhD, Lampang Hospital
- Vrchní vyšetřovatel: Phanida Krittayapoositpot, MD, Dementia Association of Thailand
- Vrchní vyšetřovatel: Worawan Chailimpamontri, MD, Bhumibol Adulyadej Hospital
- Vrchní vyšetřovatel: Ampika Mangklabruks, MD, Faculty of medicine, Chiangmai University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Duševní poruchy
- Poruchy metabolismu glukózy
- Metabolické choroby
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Nemoci dýchacích cest
- Urologická onemocnění
- Neurokognitivní poruchy
- Onemocnění endokrinního systému
- Renální insuficience
- Kardiovaskulární choroby
- Diabetes Mellitus
- Onemocnění ledvin
- Renální insuficience, chronická
- Plicní onemocnění
- Plicní onemocnění, obstrukční
- Plicní onemocnění, chronická obstrukční
- Demence
Další identifikační čísla studie
- CMR-571
- HSRI 59-069 (Jiné číslo grantu/financování: Health System Research Institute)
- TCTR20161116001 (Identifikátor registru: Thai Clinical Trials Registry)
- 59-00-0228 (Jiné číslo grantu/financování: Thai Health Promotion Foundation)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
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