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Assessment of effectiveness of Japanese school-based food and nutrition intervention (Shokuiku) program among selected primary schoolchildren in Gampaha District, Sri Lanka: a cluster randomized controlled trial
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SLCTR Registration Number
SLCTR/2020/018
Date of Registration
The date of last modification
Sep 10, 2020
Scientific Title of Trial
Assessment of effectiveness of Japanese school-based food and nutrition intervention (Shokuiku) program among selected primary schoolchildren in Gampaha District, Sri Lanka: a cluster randomized controlled trial
Public Title of Trial
Effects of school-based food and nutrition program to improve nutritional status among malnourished primary schoolchildren in Gampaha District: a cluster randomized controlled trial
Disease or Health Condition(s) Studied
Malnutrition
Scientific Acronym
None
Public Acronym
None
Brief title
Effect of Japanese school-based food and nutrition intervention (Shokuiku) program among malnourished primary school children.
Universal Trial Number
U1111-1255-0482
Any other number(s) assigned to the trial and issuing authority
P/14/02/2020
What is the research question being addressed?
Is 3 month school-based food and nutrition program effective in improving the nutritional status among malnourished primary school children?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study Setting: Selected primary schools in Gampaha district, Sri Lanka.
Method of Randomization and sample selection: Of the mixed schools in the Gampaha district, ten schools will be selected randomly. If two schools were selected within a 10 km radius, the second schools will be excluded and replaced with another school. After the selection, the schools will be assigned to the intervention or control group using a toss of a coin or a random number table.
Intervention: 90 day-school-based program Day 1. A lecture on healthy lifestyle habits will be conducted in the intervention group. This lecture will enable students to learn their growth status, food variety, and healthy snack, and recommended physical activity. During this interactive lecture, children will not only have the opportunity to acquire the knowledge on healthy lifestyle, but also to learn to check their own nutritional status by calculating BMI using height and weight measurements. Students will be encouraged to improve their diet and physical activities based on advice given for 90 days period.
Day 1 to 90: Students will be expected to select their diet and engage in physical activities based on the educational material of the program during the intervention period (90 days). To check compliance, students will be asked to complete 24 h dietary and physical activity recall randomly. The researcher will select a day randomly and students will be asked to recall previous days diet and physical activity at the school. This procedure will be repeated for 20 days per school during the 90-day intervention period. At each data collection day, research assistants will review their progress and encourage compliance. Based on the progress of each student, the research team will give feedback and continue advice to keep a healthy lifestyle. Further, to encourage compliance, the researcher will employ a progress chart with color-coded stars to commend achievements and at the end of the intervention period student with the most commendable progress at the school will be rewarded.
No intervention will be carried out for the control group. A lecture on healthy lifestyle habits will be conducted in the Control group after the study period.
Inclusion criteria
Exclusion criteria
Students who are taking medicine for any illness or on special diet plan
Primary outcome(s)
|
1.
Health and Nutritional status (Anthropocentric measurements: height (cm), weight (kg), waist circumference (cm), mid-upper arm circumference (MUAC, mm), blood pressure (mmHg), hemoglobin level (Hb, g/dL)) |
[ Timepoint: Measurements will be done at the baseline prior to intervention in both intervention and control group of children and the endline assessment will be three (3) months after initiation of the intervention. ] |
Secondary outcome(s)
|
1.
Change in mean scores of the following tools: |
[ Timepoint: Measurements will be done at the baseline prior to intervention in both intervention and control group of children and the endline assessment will be three (3) months after initiation of the intervention. ] |
Target number/sample size
320 (160 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-10-01
Anticipated end date
2021-09-30
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Japanese Society for the Promotion of Science (JSPS)
Regulatory approvals
Not Applicable
Status
Approved
Date of Approval
2020-03-10
Approval number
P/14/02/2020
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | P.O. Box 6, Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94-11-2961000 |
| Email: | info.med@kln.ac.lk |
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
