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Effectiveness of a two-Stage Community-Based Health Intervention delivered through Mothers’ Support Groups compared to usual health care services in improving knowledge and practices on childhood nutrition among Tamil speaking mothers of children aged 6–24 months in Jaffna District

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SLCTR Registration Number

SLCTR/2026/011


Date of Registration

14 May 2026

The date of last modification

May 14, 2026



Application Summary


Scientific Title of Trial

Effectiveness of a two-Stage Community-Based Health Intervention delivered through Mothers’ Support Groups compared to usual health care services in improving knowledge and practices on childhood nutrition among Tamil speaking mothers of children aged 6–24 months in Jaffna District


Public Title of Trial

Effectiveness of a two-Stage Community-Based Health Intervention delivered through Mothers’ Support Groups compared to usual health care services in improving knowledge and practices on childhood nutrition among mothers of children aged 6–24 months in Jaffna District


Disease or Health Condition(s) Studied

Health promotion regarding childhood nutrition


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1321-8864


Any other number(s) assigned to the trial and issuing authority

EC/25/184 (FoM:UoC)


Trial Details


What is the research question being addressed?

Does a two-stage community-based health intervention delivered through Mothers’ Support Groups (MSGs) compared to usual health care services, improve knowledge and practices on childhood nutrition among Tamil speaking mothers of children aged 6–24 months in Jaffna District?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Double blinded : Participants, Outcome assessors


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Supportive care


Study Phase

Not Applicable


Intervention(s) planned

Study setting: Public Health Midwife (PHM) areas with functioning MSGs in the Jaffna District Study design: A community-based cluster randomized trial will be used. Randomization: A PHM area will be the cluster. Block randomisation will be done to have balanced number of clusters. Also, Allocation concealment will be performed using the technique of “Central randomization”.

Study population: Members of the MSGs and mothers with children aged six months to two years in Jaffna District. We included mothers and members of MSGs, as the study aims to evaluate the effectiveness of community-based health interventions, such as MSGs, in delivering services.

Mothers’ Support Group: a community-based health intervention According to the MSG guidelines, MSGs/community support groups are groups of people, approximately 5-20 per group, who come together to learn about and discuss issues of health and nutrition relevant to their communities and promote good practices. These people support each other to improve awareness and practices to improve the nutritional and health status of their communities. In the mothers’ support group guidelines, priority is given to activities focused on children under five years of age.

Intervention Intervention will be digital-based health education. It will be delivered through WhatsApp group for the MSG. And then Members of MSGs will deliver the interventions to mothers within the community.

We have developed five Video audio clips and its contents are mentioned below. The intervention will address the knowledge and practices regarding childhood nutrition of Tamil speaking Members of MSGs and mothers with children aged six months to two years.

Contents included in developed intervention

Video 01- Initiation of complementary feeding – After 6 months of exclusive breast feeding, introducing nutrient-rich, safe, and appropriate foods to an infant, starting immediately on completion of 6 months; first food; amount of first food; consistency of first food; feeding environment; myth of giving first food as biscuits/other inappropriate food

Video 02 - Continuation of complementary feeding- gradual introduction of foods; amount of food with age; importance of introducing animal food, legumes and others as recommended; myths of giving animal food/legumes; frequency of feeding with age.

Video 03 - Dietary diversity- definition based on WHO’s 08 food groups, use of locally available foods to achieve dietary diversity; Home-cooked food vs Ultra processed food; snacks

Video 04 - Responsive feeding – identifying huger cues with age, no force feeding, feeding challenges; feeding during illness

Video 05 - Importance of growth monitoring; Introducing 03 growth charts; MSG members role on growth monitoring at growth monitoring post; frequency of growth monitoring for a child with normal growth; role of MSG in improving child nutrition

Number and duration of video/audio clips Five short video/audio clips were developed each ranging from 2.5 to 3 minutes in duration based on literature and expert opinion. Each clip will convey a maximum of two key health messages to ensure clarity, maintain audience attention, and optimize knowledge retention (Abdollahi et al., 2024; Adam M, McMahon SA, Prober C, 2019).

The clips will be shared 2 to 3 times per week over a period of twelve weeks, following the recommendations from prior mobile health interventions, which emphasize the importance of repetition and consistency in message delivery to reinforce learning and encourage behavioural adoption (Nembot et al., 2025; Rachmatika & Salighehdar, 2024).

The frequency of the intervention will not be restricted to specific days and time, this will be a whatsApp sharing. PI will be added in their MSG WhatsApp group and videos will be sent by PI initially. Then based on desk review their monthly MSG meeting usually be conducted in the evening after 4.30pm and in some areas around 10.30am. So, according to their convenience they can explain about the shared videos already in the group.

The clips will be shared 2 to 3 times per week over a period of twelve weeks in WhatsApp. This will be monitored using Fidelity Monitoring Checklist by PI. Therefore, it is expected that the clips will be shared totally 24 to 36 times during the 12 weeks duration.

Standard care Usually there are many programmes conducted by MOH staff to the undercare mothers and MSG members like monthly In-service training, monthly MSG meetings (even though control group will be not shared videos, they will have their meetings and discuss relevant health topic), antinatal care classes, Provision of complementary feeding book, complementary feeding classes at MOH office etc.

Blinding Due to the nature of the WhatsApp-based video education intervention, full double blinding is not feasible. However, the study incorporates strategies to minimize bias.

Participants are enrolled and baseline data are collected prior to intervention delivery, and group allocation is not disclosed at this stage. While participants are not explicitly informed of their allocation, those receiving the intervention may infer their status; therefore, this is considered partial participant masking rather than full blinding.

To reduce contamination, participants receiving the intervention are requested not to share educational materials outside their group during the 3-month study period, and public health midwives (PHMM) are informed to support adherence.

The control group does not receive the intervention during the study period but will be provided access to the educational videos after completion of data collection.

Importantly, data collectors (outcome assessors) are fully blinded to group allocation and are not involved in intervention delivery. Standardized data collection procedures are used to further minimize detection bias.


Inclusion criteria

Members of the MSGs (all ages) and mothers with children aged six months to two years in Jaffna District.


Exclusion criteria

Participants from island public health midwife (PHM) areas



Primary outcome(s)

1.

Primary outcome: Participants % change in knowledge and practice scores, which will be calculated targeting following components. - Knowledge and practice on complementary feeding - Knowledge and practice on feeding technique - Knowledge and practice on breastfeeding over formula feeding - Benefits of the consumption of home-cooked healthy food over ultra-processed food - Knowledge and practice on dietary diversity - Knowledge and practice on responsive feeding - Knowledge and practice on Feeding during illness - Common misconception about child nutrition/feeding - Knowledge and practice on Growth monitoring - Knowledge and practice on role of MSG on childhood nutrition Using a inhouse developed (content and face validated) questionnaire

[

After 03 months of intervention delivery

]

Secondary outcome(s)

1.
  • Knowledge on exclusive breast feeding
  • Complementary feeding practices
  • Responsive feeding
  • Feeding during and after illness
  • Dietary diversity
  • Myths regarding feeding practices
  • Encouraging the consumption of home-cooked healthy food over ultra-processed food
  • Growth monitoring and promotion: Understanding the purpose of growth monitoring, determining the appropriate frequency for measuring weight and length
  • Knowledge on role of MSG in childhood nutrition
[

After 03 months of intervention delivery

]

Target number/sample size

1008 (504 MSGs and mothers in one arm); 84 clusters (42 clusters in one arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2026-05-15


Anticipated end date

2026-12-22


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals

Pending



State of Ethics Review Approval


Status

Approved


Date of Approval

2026-03-19


Approval number

EC-25-184


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Colombo
Institutional Address:P O Box 271, Kynsey Road, Colombo 8, Sri Lanka
Telephone:+94-11-2695300 ext 240 : Fax: +94-11-2691581
Email: erc@med.cmb.ac.lk

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.S.Suganja
Lecturer in Community Medicine
Department of Community and Family Medicine, Faculty of Medicine, University of Jaffna
0212218178
+94772583080

ssuganja@univ.jfn.ac.lk

Contact Person for Public Queries

Dr. Supun Wijesinghe
Consultant Community Physician
Head / Family Health, Nutrition Communication & Behaviour Research Unit Health Promotion Bureau Ministry of Health
+94777945854
+94777945854

drwijesinghe@gmail.com


Primary study sponsor/organization

None





Secondary study sponsor (If any)

None





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