Home » Trials » SLCTR/2013/011
Effectiveness of a school based intervention to enable school children to act as change agents in promoting healthy lifestyles among mothers: a cluster randomized controlled trial
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SLCTR Registration Number
SLCTR/2013/011
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effectiveness of a school based intervention to enable school children to act as change agents in promoting healthy lifestyles among mothers: a cluster randomized controlled trial
Public Title of Trial
Effectiveness of a school based intervention to enable school children to act as change agents in promoting healthy lifestyles among mothers
Disease or Health Condition(s) Studied
Life styles
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
ERC/12-039 (Ethics Review Committee of the Sri Lanka Medical Association)
What is the research question being addressed?
Can school children to act as change agents in promoting healthy lifestyles related to dietary habits and physical exercise among their mothers? Can school children to act as change agents in suppressing weight increase among their mothers? Can school children to act as change agents in 1. promoting healthy lifestyles related to dietary habits and physical exercise among their mothers? 2. suppressing weight increase among their mothers in general ? 3. decreasing body weight specifically among their overweight/obese mothers?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Available
Intervention(s) planned
Trained health promotion facilitators will conduct group activities among the school children selected to be in the intervention group. Intervention activities will include building capacity of school children to identify determinants of poor physical activity and unhealthy dietary habits responsible for obesity of their mothers. Upon identification of the determinants, the intervention activities will capacitate the school children to initiate the necessary processes to modify selected determinants – so as to improve physical activities and dietary habits among mothers. The intervention will be conducted over a period of one year and will comprise monthly periodic inputs to the school children on maintaining activities to improve physical activity and desired dietary habits among their mothers. The school children selected to be in the control group will not receive any interventional activities.
Inclusion criteria
Grade 8 students of the selected intervention and control school clusters will comprise the participants. Outcome measures will be done on mothers of the students
Exclusion criteria
Exclusion criteria for students • if the mother of the student is pregnant •if the mother of the student is under special diet plans of a dietician/ medical professional
If the mother becomes pregnant following recruitment, she will be advised accordingly and considered "lost to follow-up"
Primary outcome(s)
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1.
Level of physical activity among mothers, using
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[ Measurements will be done at the baseline prior to intervention in both intervention and control group of women and the endline assessment will be one year after initiation of the intervention ] |
|
2.
Dietary assessment among mothers using -Food Frequency Questionnaire –Sinhalese version validated to the local setting to assess the (Arambepola, 2004) -A self-administered questionnaire to assess food habits - 24 hour dietary recall for the day prior to the assessment |
[ Measurements will be done at the baseline prior to intervention in both intervention and control group of women and the endline assessment will be one year after initiation of the intervention ] |
|
3.
Body Mass Index |
[ Measurements will be done at the baseline prior to intervention in both intervention and control group of women and the endline assessment will be one year after initiation of the intervention ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
330 (165 in each group)
Countries of recruitment
Sri Lanka
Anticipated start date
2013-04-01
Anticipated end date
2014-04-01
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
The Grant of National Center for Global Health and Medicine
Regulatory approvals
Status
Approved
Date of Approval
2013-01-18
Approval number
ERC/12-039
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
Nalika Gunawardena
Senior Lecturer in Community Medicine
Dept. Community Medicine, Fcaulty of Medicine, University of Colombo
0112677765
0776975402
nalikaguna@hotmail.com
Contact Person for Public Queries
Nalika Gunawardena
Senior Lecturer in Community Medicine
Dept. Community Medicine, Fcaulty of Medicine, University of Colombo
0112677765
0776975402
nalikaguna@hotmail.com
Primary study sponsor/organization
The Grant of National Center for Global Health and Medicine Japan
mizoue@ri.ncgm.go.jp
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
