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. -

SLCTR Registration Number

SLCTR/2017/022


Date of Registration

18 Jul 2017

The date of last modification

Jul 18, 2017



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 of 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 Trail 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


Assignment

Parallel


Purpose

Prevention


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)

  2. Physical activity performed (using the WHO-global Physical Activity Questionnaire)


Primary outcome(s) - Time of assessment(s)

At baseline, 6 months and 12 months after commencement of the intervention


Secondary outcome

Knowledge and awareness of NCD and its related factors

  1. Knowledge and awareness regarding effects of tobacco using self-developed questionnaire

  2. Knowledge and awareness regarding effects of alcohol consumption using self-developed questionnaire

  3. Knowledge and awareness regarding effects of physical inactivity using self-developed questionnaire

  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.


Secondary outcome(s) - Time of assessment(s)

Knowledge and awareness of NCD and its related factors

  1. Knowledge and awareness regarding effects of tobacco using self-developed questionnaire

  2. Knowledge and awareness regarding effects of alcohol consumption using self-developed questionnaire

  3. Knowledge and awareness regarding effects of physical inactivity using self-developed questionnaire

  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.



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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethical Review Board of the Nepal Health Research Council on 19th May 2016 (Ref 300/2015)


Funding source

Government of Nepal (Nepal Health Research Council)



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