Home » Trials » SLCTR/2017/022
Community based intervention for primary prevention and control of Non-communicable disease (NCD) risk factors in Ilam and Dhankuta districts, Nepal.
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SLCTR Registration Number
SLCTR/2017/022
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Community based intervention for primary prevention and control of Non-communicable disease (NCD) risk factors in Ilam and Dhankuta districts, Nepal.
Public Title of Trial
Community based intervention for primary prevention and control of Non-communicable disease (NCD) risk factors in Ilam and Dhankuta districts, Nepal.
Disease or Health Condition(s) Studied
Non-communicable disease
Scientific Acronym
CIPCON (Community based Intervention for Prevention and Control of NCD risk factors)
Public Acronym
CIPCON (Community based Intervention for Prevention and Control of NCD risk factors)
Brief title
Community based interventional study on Non-communicable disease
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
300/2015 (Ethics Review Board, Nepal Health Research Council)
What is the research question being addressed?
What is the effectiveness of a targeted primary intervention package when compared to standard practice, in decreasing prevalence of Non-Communicable Disease related risk factors?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out in 12 selected Village Development Committees (VDCs) of Ilam district, Nepal.
12 VDCs will be allocated to the intervention arm and 12 VDCs will be allocated to the control arm.
The population in the intervention arm will be offered a comprehensive intervention package including: 1) School Health Education program: 1.1. NCD related training to school teacher twice a year 1.2. Health education sessions (45 min each) every week for 8 months, covering the following topics: nutrition, exercise, smoking, fruits and vegetables. 1.3. One Orientation program regarding in each school’s school development committee
2) The Female Community Health Volunteer intervention will include 2.1. Female Community Health Volunteer orientation program twice a year
2.2 Health education sessions in the mothers group (1 hour each) held once a month for 6 months, covering the following topics: nutrition, exercise, smoking, fruits and vegetables
The control arm will receive conventional health education by counseling on health facilities, delivering Information, Education, and Communication (IEC) Materials etc. according to standard protocols by the Government.
Inclusion criteria
Exclusion criteria
No exclusion criteria applied
Primary outcome(s)
|
1.
Current tobacco use (modified WHO Global Adult Tobacco Survey) |
[ At baseline, 6 months and 12 months after commencement of the intervention ] |
|
2.
Physical activity performed (using the WHO-global Physical Activity Questionnaire) |
[ At baseline, 6 months and 12 months after commencement of the intervention ] |
Secondary outcome(s)
|
1.
Knowledge and awareness of NCD and its related factors 1.1. Knowledge and awareness regarding effects of tobacco using self-developed questionnaire 1.2. Knowledge and awareness regarding effects of alcohol consumption using self-developed questionnaire 1.3. Knowledge and awareness regarding effects of physical inactivity using self-developed questionnaire 1.4. Knowledge and awareness regarding effects of less food and vegetable consumption using self-developed questionnaire Additionally, STEPS 3.1 version questionnaire along with a structure questionnaire for assessing knowledge and attitudes regarding NCDs will be used to assess the secondary outcomes. |
[ At baseline and 12 months after commencement of the intervention ] |
Target number/sample size
12 VDCs of the selected Districts in each arm (approximately 20,048 households consisting 92,352 population)
Countries of recruitment
Nepal
Anticipated start date
2017-07-24
Anticipated end date
2018-07-24
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Government of Nepal (Nepal Health Research Council)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-05-19
Approval number
300/2015
Details of Ethics Review Committee
| Name: | Ethical Review Board of the Nepal Health Research Council |
| Institutional Address: | PO Box 7626, Ramshah Path, Kathmandu, Nepal |
| Telephone: | +977-14254220 |
| Email: | nhrc@nhrc.org.np |
Contact person for Scientific Queries/Principal Investigator
Dr. Khem Bahadur Karki
Member Secretary
Nepal Health Research Council
Ministry of Health Complex
Ramshah Path
Kathmandu 44600, Nepal
Mob: +977-9851054190
kkarki@nhrc.org.np
Contact Person for Public Queries
Dr. Krishna Aryal
Chief, Research Section
Nepal Health Research Council
Ministry of Health Complex
Ramshah Path
Kathmandu 44600, Nepal
Mob: +977-9851123730
krish.aryal@gmail.com
Primary study sponsor/organization
Nepal Health Research Council
Ministry of Health Complex
Ramshah Path
Kathmandu 44600, Nepal
nhrc nhrc <nhrc@nhrc.org.np>
http://nhrc.org.np/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
