Home » Trials » SLCTR/2026/011
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
The date of last modification
May 14, 2026
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)
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.
|
[ 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
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 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
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