Home » Trials » SLCTR/2019/028


Design, implementation and evaluation of a community intervention to improve utilization of healthy lifestyle centers in two districts in Sri Lanka.

-

SLCTR Registration Number

SLCTR/2019/028


Date of Registration

06 Sep 2019

The date of last modification

Sep 09, 2019



Application Summary


Scientific Title of Trial

Design, implementation and evaluation of a community intervention to improve utilization of healthy lifestyle centers in two districts in Sri Lanka.


Public Title of Trial

Evaluating the effectiveness of a community empowerment programme in improving utilization of the healthy lifestyle center by people between 35 and 65 years of age attending a selected primary care unit in a selected district in Sri Lanka – A non-randomized control trial


Disease or Health Condition(s) Studied

Health service utilization


Scientific Acronym

None


Public Acronym

None


Brief title

A community intervention to improve utilization of healthy lifestyle centers in Sri Lanka


Universal Trial Number

U1111-1236-9986


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

ERC number - P/141/07/2018 Grant number - AHEAD/PhD/R1/AH/037


Trial Details


What is the research question being addressed?

Can a community empowerment programme improve the utilization of a healthy life style center in a selected district in Sri Lanka?


Type of study

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Health services research


Study Phase

Not Applicable


Intervention(s) planned

Study setting: Intervention will be conducted in the catchment area of the healthy lifestyle center in Kotadeniyawa Primary Medical Care Unit in the Gampaha diistrict and the control group will be from the catchment area of the healthy lifestyle center in Bellana central dispensary in the Kalutara district.

Frequency: Communities who are residing in the catchment area of the intervention group will be meeting monthly.

Total duration: Six months

• Intervention 1: Large group discussion with people in the community in the first month for 3 hours Awareness on health and importance of early diagnosis will be improved via an interactive discussion. Training via role-plays will be conducted to improve the skill among participants to spread the importance of healthy lifestyle centers.

• Intervention 2: Small group discussions with community members who show an interest and who are willing from the second month to sixth month. One discussion will last a maximum of 1 hour and will be conducted monthly.Strategies for improving their physical well being will be discussed.

• Intervention 3: Forming a community support group using active people from intervention 1 and 2. This group will be meeting monthly after the 3rd month and one meeting will be conducted for 2 hours. This group will be trained as a community support group for prevention of non-communicable diseases.


Inclusion criteria

  1. Male and female
  2. People who are 35-65 years of age
  3. People who are registered in the electoral lists of the selected clusters in Gampaha and Kalutara

Exclusion criteria

  1. People who are not mentally sound
  2. Disabled people
  3. Females who are pregnant at the time of intervention
  4. Females who delivered a child 6 months prior to the intervention
  5. People who are a abroad at the time of intervention


Primary outcome(s)

1.
  1. Percentage change in attendance of the number of people attending the healthy life style center before and after the intervention
[

6 months and 1 year following the start of the intervention

]
2.
  1. Percentage of people who have changed at least one behavior in relation to at least one major behavioral risk factor for Non Communicable Diseases.
[

6 months and 1 year following the start of the intervention

]
3.
[]
4.
[]
5.
[]
6.
[]
7.
[]
8.
[]
9.
[]
10.
[]
11.
[]
12.
[]
13.
[]
14.
[]
15.
[]
16.
[]
17.
[]
18.
[]
19.
[]
20.
[]
21.
[]
22.
[]
23.
[]
24.
[]
25.
[]
26.
[]
27.
[]
28.
[]
29.
[]
30.
[]
31.
[]
32.
[]
33.
[]
34.
[]
35.
[]
36.
[]
37.
[]
38.
[]
39.
[]
40.
[]
41.
[]
42.
[]
43.
[]
44.
[]
45.
[]
46.
[]
47.
[]
48.
[]
49.
[]
50.
[]
51.
[]

Secondary outcome(s)

1.

Level of perceived support from family

[

6 months after the intervention

]
2.

Level of perceived social support for reducing risk for Non Communicable Diseases.

[

6 months after the intervention

]
3.

Level of awareness on healthy lifestyle centers

[

6 months after the intervention

]

Target number/sample size

968 Intervention arm- 484 Control arm-484


Countries of recruitment

Sri Lanka


Anticipated start date

2019-09-17


Anticipated end date

2020-03-17


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

World Bank through Accelerating Higher Education Expansion and Development (AHEAD) Programme Reference number: AHEAD/PhD/R1/AH/037


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-06-24


Approval number

P/141/07/2018


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya, Sri Lanka
Institutional Address:PO Box 06, Thalagolla Road, Ragama
Telephone:+94112961267
Email: ercmed@kln.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Thilini Herath
Lecturer (Probationary)
Department of Primary Health Care, Faculty of Health Care Sciences, Eastern University, No.50, New Kalmunai Road, Batticaloa

+94718175169

herathhmtp@gmail.com

Contact Person for Public Queries

Dr. K M N Perera
Senior Lecturer in Public Health
Department of Public Health, Faculty of Medicine, University of Kelaniya, Annasihena Road, Ragama,Sri Lanka

+94718303633

kmanujanp@gmail.com


Primary study sponsor/organization

World Bank through Accelerating Higher Education Expansion and Development (AHEAD) Programme





Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


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