- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상태
개입 / 치료
상세 설명
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
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Ubon Ratchathani
-
Muaeng, Ubon Ratchathani, 태국, 34000
- Sanpasitthiprasong Hospital
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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.
|
간섭 없음: Control
No special intervention will be given.
Prevention and treatment in normal practice is allowed
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Dementia
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Type 2 diabetes mellitus
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 1, 2, 5 and 10 years
|
Blood lipids include total, LDL- and HDL-cholesterol and triglyceride
|
1, 2, 5 and 10 years
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Physical activity levels
기간: 1, 2, 5 and 10 years
|
Physical activity levels assessed using the global physical activity questionnaire (GPAQ)
|
1, 2, 5 and 10 years
|
Diet
기간: 1, 2, 5 and 10 years
|
Diet assessed by 24 hour food recall
|
1, 2, 5 and 10 years
|
Prevalence of current smokers
기간: 1, 2, 5 and 10 years
|
Percentage of current smokers in the study samples
|
1, 2, 5 and 10 years
|
Prevalence of alcohol consumption
기간: 1, 2, 5 and 10 years
|
Percentage of those who report alcohol consumption
|
1, 2, 5 and 10 years
|
Cognitive function
기간: 2, 5 and 10 years
|
Cognitive function assessed by MMSE score
|
2, 5 and 10 years
|
공동 작업자 및 조사자
협력자
수사관
- 연구 책임자: Prasert Boongird, MD, Dementia Association of Dementia
- 수석 연구원: Parinya Chamnan, MD, PhD, Sanpasitthiprasong Hospital
- 수석 연구원: Wannee Nitiyanant, MD, Siriraj Hospital
- 수석 연구원: Wichai Aekplakorn, MD, PhD, Ramathibodi Hospital, Mahidol University
- 수석 연구원: Chanida Pachotikarn, PhD, Thai Dietetic Society
- 수석 연구원: Chaicharn Deerochanawong, MD, Rajvithi Hospital
- 수석 연구원: Surasak Kantachuvesiri, MD, PhD, Ramathibodi Hospital, Mahidol University
- 수석 연구원: Wallaya Jongjaroenprasert, MD, Ramathibodi Hospital, Mahidol University
- 수석 연구원: Atiporn Ingsathit, MD, PhD, Ramathibodi Hospital, Mahidol University
- 수석 연구원: Win Techakehakij, MD, PhD, Lampang Hospital
- 수석 연구원: Phanida Krittayapoositpot, MD, Dementia Association of Thailand
- 수석 연구원: Worawan Chailimpamontri, MD, Bhumibol Adulyadej Hospital
- 수석 연구원: Ampika Mangklabruks, MD, Faculty of medicine, Chiangmai University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CMR-571
- HSRI 59-069 (기타 보조금/기금 번호: Health System Research Institute)
- TCTR20161116001 (레지스트리 식별자: Thai Clinical Trials Registry)
- 59-00-0228 (기타 보조금/기금 번호: Thai Health Promotion Foundation)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
심혈관 질환에 대한 임상 시험
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University of Pennsylvania완전한Intrntl Classification of Diseases, 9th Revision, (ICD-9-CM) 410의 주진단 또는 이차진단 코드가 있는 환자(5번째 숫자가 2인 경우 제외)미국
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