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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 -

SLCTR Registration Number

SLCTR/2017/002


Date of Registration

19 Jan 2017

The date of last modification

Jan 19, 2017



Application Summary


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 of Health Condition(s) Studied

Cardiovascular Disease risk


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

U1111-1187-6066


Any other number(s) assigned to the trial and issuing authority

ERC/15/040 (ERC: SLMA)


Trial Details


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


Assignment

Parallel


Purpose

Prevention


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

  1. Physical disabilities
  2. Pregnancy


Primary outcome(s)

  1. Body mass index
  2. Weight
  3. Blood pressure

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

At recruitment and 12 months after commencement of the intervention


Secondary outcome

  1. Physical activity, including sedentary time (watching TV etc.)
  2. Fruit and vegetable consumption, sugar-sweetened food and beverage consumption
  3. Alcohol and tobacco use

Outcomes will be 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).

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).


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

  1. Physical activity, including sedentary time (watching TV etc.)
  2. Fruit and vegetable consumption, sugar-sweetened food and beverage consumption
  3. Alcohol and tobacco use

Outcomes will be 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).

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).



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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of the Sri Lanka Medical Association 19th February 2016 (Ref.: ERC/015-040)


Funding source

National Center for Global Health and Medicine, Japan



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None