Home » Trials » SLCTR/2013/022
Effectiveness of a skill development intervention to improve nutrition literacy in a group of females aged 25-45 years.
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SLCTR Registration Number
SLCTR/2013/022
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effectiveness of a skill development intervention to improve nutrition literacy in a group of females aged 25-45 years.
Public Title of Trial
Effectiveness of a skill development intervention to improve ability to obtain and understand nutrition information in a group of females aged 25-45 years,in the Colombo District
Disease or Health Condition(s) Studied
Nutrition literacy
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC-11-177 (Ethics Review Committee, Faculty of Medicine, University of Colombo)
What is the research question being addressed?
What is the effect of a skill development intervention on improving nutrition literacy?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Available
Intervention(s) planned
This is a cluster randomized trial with two educational sessions for each cluster. Cluster size is 18, and here will be 12 clusters each in the intervention and the control group. This will be done in two selected GN divisions in Colombo District.
Skill development interventions would use commonly available nutrition material for public, such as food labels, food guide pyramid and group activities will be done to improve understanding of the material. Discussions will be conducted on family food decision making process.
The control group would not receive any educational sessions.
Inclusion criteria
Females between 25-45 years Scoring between 25%-75% in a validated nutrition literacy test
Exclusion criteria
Non consenting females
Primary outcome(s)
|
1.
Change in the nutrition literacy score (using the validated nutrition literacy test) |
[ 4 months following the 1st intervention ] |
Secondary outcome(s)
|
1.
Improvement in the food choices and ability to access and understand commonly available nutrition information (using a structured questionnaire) |
[ At baseline and 4 months following the 1st intervention ] |
Target number/sample size
216
Countries of recruitment
Sri Lanka
Anticipated start date
2013-06-28
Anticipated end date
2013-10-10
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
National Science Foundation
Regulatory approvals
Status
Approved
Date of Approval
2011-11-17
Approval number
EC-11-177 (Extended on 17.11.2012)
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr Yasoma Weerasekara
Registrar in Community Medicine
Medical Research Institute,Colombo
0718377106
yasoma.kumari@yahoo.com
Contact Person for Public Queries
Dr Nalika Gunawardena
Senior Lecturer in Community Medicine
Faculty of Medicine, University of Colombo,
No 25, Kynsey Road, Colombo 8.
2-695300
nalikaguna@hotmail.com
Primary study sponsor/organization
National Science Foundation
475/5, Maitland Place,Colombo 7
+94 011 2696771
info@nsf.ac.lk
http://www.nsf.ac.lk/
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
