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.
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SLCTR Registration Number
SLCTR/2019/028
Date of Registration
The date of last modification
May 07, 2021
Trial Status
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
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
Exclusion criteria
Primary outcome(s)
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[ 6 months and 1 year following the start of the intervention ] |
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Secondary outcome(s)
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Level of perceived support from family |
[ 6 months after the intervention ] |
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Level of perceived social support for reducing risk for Non Communicable Diseases. |
[ 6 months after the intervention ] |
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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
2019-09-17
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
World Bank through Accelerating Higher Education Expansion and Development (AHEAD) Programme Reference number: AHEAD/PhD/R1/AH/037
Regulatory approvals
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 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
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
