Home » Trials » SLCTR/2017/002
Effect of an intervention to enable young people to act as change agents to reduce cardiovascular disease risk of their community: a cluster randomized controlled trial
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SLCTR Registration Number
SLCTR/2017/002
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Effect of an intervention to enable young people to act as change agents to reduce cardiovascular disease risk of their community: a cluster randomized controlled trial
Public Title of Trial
An intervention study to enable young people to act as change agents to reduce cardiovascular risk of their community in Sri Lanka
Disease or Health Condition(s) Studied
Cardiovascular Disease risk
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1187-6066
Any other number(s) assigned to the trial and issuing authority
ERC/15/040 (ERC: SLMA)
What is the research question being addressed?
What is the effectiveness of a health promotion intervention in enabling young people to act as change agents to reduce cardiovascular disease risk of their communities?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study setting: District of Colombo in 24 selected Grama Niladari (GN) divisions of four randomly selected Divisional Secretariat (DS) divisions
Study design: Cluster randomized trial. A cluster is defined as adults (18 years or older) resident in the pre-identified 100 houses within the GN division with an existing club/society of young people.
The 24 GN clusters will be selected from the total 566 GN divisions using simple randomization. Allocation to intervention and control arms would be through a lottery method. Roads maps of the selected GN area would serve as the sampling frame. A location of each map would be randomly selected to serve as the starting point to select the houses to be included in the study and approximately 100 houses located on around the point will be identified.
Intervention arm
Young people (aged 15-29 years) who are members of a registered youth club/society will be trained and guided to design and deliver the interventions by the trained filed health promoter and the two doctors with post graduate qualifications in public health among the team of investigators of the study.
a) The intervention is based on the principles of health promotion.
b) Trained health promotion facilitators will visit the intervention areas and deliver the intervention in the form of a series of discussion with the young people who are members of the youth clubs/societies.
c) A minimum of 2 discussions/ month will be carried out at each cluster during the first 3 months
d) The initial 3- 4 discussions will be based on the concept of ‘health’ and ‘well-being’
e) The subsequent discussions will be on NCD risk factors (i.e. obesity, sedentary behavior, unhealthy diet, tobacco and alcohol use)
f) Each discussion will be held for a duration of 1-4 hours depending on the understanding and enthusiasm of the youth club members
g) The youth will carry out activities in their communities based on the identified determinants
The specific change activities to address the risk factors will be decided as a part of the study, based on the determinants that will be identified by the young people/communities on a priority basis.
The change activities targeting the adult residents of the identified 100 houses in the clusters of the intervention arm will be conducted by the trained young people.
Control arm
The clusters in the control arm will not receive any interventional activities.
Outcomes will be assessed by data collectors who will be blinded on their intervention/control status.
Inclusion criteria
Males and females aged 30-59 years residing in the randomly selected clusters
Exclusion criteria
Primary outcome(s)
1.
Body mass index |
[ At recruitment and 12 months after commencement of the intervention ] |
2.
Weight |
[ At recruitment and 12 months after commencement of the intervention ] |
3.
Blood pressure |
[ At recruitment and 12 months after commencement of the intervention ] |
Secondary outcome(s)
1.
Physical activity, including sedentary time (watching TV etc.) - assessed using the WHO STEPS instrument developed and utilized in Sri Lanka (Ministry of Healthcare and Nutrition,2008) and locally validated food frequency questionnaire (Arambepola,2004) and International Physical activity questionnaire (IPAQ) (Karunapema, 2007). |
[ At recruitment and 12 months after commencement of the intervention ] |
2.
Fruit and vegetable consumption, sugar-sweetened food and beverage consumption - assessed using the WHO STEPS instrument developed and utilized in Sri Lanka, locally validated food frequency questionnaire and International Physical activity questionnaire (IPAQ) |
[ At recruitment and 12 months after commencement of the intervention ] |
3.
Alcohol and tobacco use - assessed using the WHO STEPS instrument developed and utilized in Sri Lanka, locally validated food frequency questionnaire and International Physical activity questionnaire (IPAQ) |
[ At recruitment and 12 months after commencement of the intervention ] |
4.
CVD absolute risk score, defined as the probability of experiencing a cardiovascular disease, or cardiovascular-disease-related event within 5 years after the risk assessment (Gaziano et al, 2015). |
[ At recruitment and 12 months after commencement of the intervention ] |
Target number/sample size
480 (240 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-02-01
Anticipated end date
2017-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Center for Global Health and Medicine, Japan
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2016-02-19
Approval number
ERC/015-040
Details of Ethics Review Committee
Name: | Ethics Review Committee, Sri Lanka Medical Association, |
Institutional Address: | No 6, Wijerama Mawatha, Colombo 00700 Sri Lanka |
Telephone: | +94-11-2693324 |
Email: | erc.slma@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Nadeeka Chandraratne
Principal Investigator
Foundation for Health Promotion (FHP)
21/1, 1/1; Kahawita Road, Attidiya,
Dehiwala.
Tel: 011-2731997
Mob: 071-3075696
Fax: 011-2731997
fhpsl@sltnet.lk
Contact Person for Public Queries
Dr. Diyanath Samarasinghe
Consultant Psychiatrist
Foundation for Health Promotion (FHP)
21/1, 1/1; Kahawita Road, Attidiya,
Dehiwala.
Tel: 011-2731997
071-3075696
011-2731997
fhpsl@sltnet.lk
Primary study sponsor/organization
National Center for Global Health and Medicine, Japan
1-21-1,
Toyama,Shinju ku
Tokyo, Japan
Tel: 0332027181 Ext 2857
mizoue@ri.ncgm.go.jp
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