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

26 Jun 2026

The date of last modification

Jun 26, 2026



Application Summary


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)


Trial Details


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

  • Teachers who have experience of less than three months at the ECCD center
  • Assistant/trainee teachers who have experience less than one year at an ECCD center
  • Teachers who will not be available for entire four months of the intervention ( who plan to get retired or vacate the job during intervention period)


Primary outcome(s)

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.

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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



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization

Post Graduate Institute of Medicine, University of Colombo

160, Prof. Nandadasa Kodagoda Rd, Colombo
0112 696 261


Secondary study sponsor (If any)







Trial Completion details


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