Home » Trials » SLCTR/2026/016
Ultra-processed food consumption of preschoolers in Gampaha district: Knowledge, attitudes and practices of mothers and teachers, household expenditure and the effectiveness of a training package for teachers to promote healthy food habits in preschoolers
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SLCTR Registration Number
SLCTR/2026/016
Date of Registration
The date of last modification
Jun 26, 2026
Scientific Title of Trial
Ultra-processed food consumption of preschoolers in Gampaha district: Knowledge, attitudes and practices of mothers and teachers, household expenditure and the effectiveness of a training package for teachers to promote healthy food habits in preschoolers
Public Title of Trial
A cluster Randomized Control trial to evaluate the effectiveness of a preschool teacher training package to empower children and mothers to change their food habits and food purchasing practices in Gampaha District Sri Lanka
Disease or Health Condition(s) Studied
Health promotion, Nutrition
Scientific Acronym
None
Public Acronym
None
Brief title
The effectiveness of a preschool teacher training package to empower children and mothers to change their food habits and food purchasing practices
Universal Trial Number
U1111-1338-5818
Any other number(s) assigned to the trial and issuing authority
P/256/12/2025 (ERC Fculty of Medicine, University of Kelaniya)
What is the research question being addressed?
What is the level of effectiveness of a training package in empowering preschool teachers to engage preschool children and their mothers to promote healthy food habits and reallocate household expenditure of ultra processed food to nutritious and healthy food in a selected Medical Officer of Health area in Gampaha District.
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Other
Purpose
Prevention
Study Phase
Not Applicable
Intervention(s) planned
Study Design: A cluster randomized control trial. Participatory processes of this trial will be embedded in the intervention process thus integrating the principles of Participatory action research and Community-based participatory research(CBPR)
Study Setting: Early Childhood Care and Development Centers (ECCD) in Ragama Medical Officer of Health (MOH) area, Gampaha District Sri Lanka
Study Population:Teachers in ECCD centers in selected MOH areas
Randomization Unit of randomization is the MOH area. First, depending on Phase I results MOH areas were paired with similar characteristics. One pair was randomly selected using simple randomization (via Computer generated random numbers) From the selected pair, One MOH area was allocated to intervention (Ragama) One MOH area was allocated to control (Attanagalla) No further randomization was done at preschool or individual level. Fixed 1:1 allocation at MOH level via single random number generation (1 -10) on pre specified rule. odd number Ragama = Intervention Attanagalla= Control If even number Attanagalla = Intervention Ragama = Control
Among two selected MOH areas, an independent statistician generated single random number between 1 and 10 and applied prespecified rule.
Intervention: There will be three components of this trial
Component 1 : Pre evaluation Component 1A This will be conducted to assess the existing maternal knowledge, attitudes and practices on children’s food habits in selected ECCD centers. The food environment and dietary behaviors of children at ECCD centers will also be assessed during this phase. Component 1 B This will be conducted to assess the knowledge and attitudes of teachers on children’s food habits in selected ECCD centers. The food environment and dietary behaviors of children at ECCD centers will also be assessed during this phase.
Component 2 : Intervention Step 1: Inviting at least one teacher from the consenting ECCD Centers at the pre-intervention evaluation Step 2: Session 1 – Initiation of the training with an introduction to concepts of healthy food habits and engaging preschool children and their parents in promoting healthy food habits and reducing Ultra processed food (UPF) consumption. Step 3: Teachers initiate processes to promote healthy food habits and reduction of UPF consumption in their preschool communities Step 4: Establishing a WhatsApp chat group to initiate discussions and give distal inputs to improve processes. The group chat will continue till the end of the intervention and beyond, upon their consent Step 5: Session 2 (two weeks after the session 1) – Teachers report back with their experiences and their processes are discussed and improved, further actions and monitoring mechanisms identified. Step 6: Monitoring visit (one month after the session 1) – ECCD centers will be visited and direct inputs given to improve processes and outcomes Step 7: Monthly Zoom meetings to assess progress and provide technical input will be held from third month onwards Step 8: Evaluation visit (4 months after session 1) – Process evaluation and the Post evaluation (Phase III)
Component 3 : Post Evaluation Same protocols will be used during the pre-evaluation phase.
No training package will be used at Control MOH area. Usual practices only. (Allowing teachers to continue the usual practices on child nutrition at their ECCD centers as per their curriculum). Control arm receives same pre- and post-evaluation assessments.
Both arms continue to receive routine guidance and care from Early Childhood Development Officers with monthly meetings. Care and support given by the Public Health Midwife as a routine in measuring child weight and height will continue normally. Neither arm is deprived of usual services.
Inclusion criteria
All teachers who are permanent employees of the ECCD Centers in the selected MOH areas Assistant/ trainee teachers working at the ECCD centers in the selected MOH area Teachers who are nominated by the preschool upon the request of the researchers. Age over 18 Both male and female
Exclusion criteria
Primary outcome(s)
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1.
Level of empowerment for promotion of healthy food habits among children and level of empowerment for controlling UPF consumption among children (among mothers and teachers) Measured using structured questionnaire (Annex 1) developed following literature review and expert opinion. |
[ At the end of the trial ( end of 4 months) ] |
|
2.
Percentage of total score obtained for knowledge on unhealthy diet related issues measured using pretested interviewer administered questionnaire (during Phase 1 component 2 in this study) |
[ At the end of the trial ( end of 4 months) ] |
|
3.
Proportion of teachers and mothers who feel responsible for the health and nutrition of children Structured questionnaire (annex 1) developed following literature review and expert opinion. |
[ At the end of the trial( end of 4 months) ] |
|
4.
Proportion of teachers and mothers who participate in nutrition promotion processes at ECCD centers |
[ At the end of the trial ( end of 4 months) ] |
|
5.
Proportion of household expenditure on ultra processed food Assessed by pretested interviewer administered questionnaire |
[ [ At the end of the trial (end of 4 months)] ] |
Secondary outcome(s)
|
1.
Evaluation of the process of the intervention (Recruitment,reach,fidelity,dose delivered,dose recived and context) |
[ At mid point ( 2 months) and at the end of the trial ] |
Target number/sample size
74 participants per arm
Countries of recruitment
Sri Lanka
Anticipated start date
2026-07-01
Anticipated end date
2026-11-15
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self funded
Regulatory approvals
Status
Approved
Date of Approval
2026-02-02
Approval number
P/256/12/2025
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | Faculty of Medicine, University of Kelaniya, PO Box 06,Thalagolla Road, Ragama, Sri Lanka |
| Telephone: | +94-112961267 |
| Email: | ercmed@kln.ac.lk |
Contact person for Scientific Queries/Principal Investigator
A.M.C.M. Gunathilake
Registrar in Community Medicine
Post Graduate Institute of Medicine, U
011-2696261
0712453741
m37719@pgim.cmb.ac.lk
Contact Person for Public Queries
Dr K.M.N Perera
Senior Lecturer
Department of Public Health, Faculty of Medicine, University of Kelaniya
0718303633
manuja@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