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

18 Jul 2017

The date of last modification

Jan 29, 2019



Application Summary


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)


Trial Details


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

  1. Male and female residents of the selected districts
  2. Age 15 years and above

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



State of Ethics Review Approval


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 & Sponsor Information


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/

Secondary study sponsor (If any)

None





Trial Completion details


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