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Improving Safe Infant Sleep Practices to Prevent Sudden Infant Death Syndrome (SIDS) Among Pregnant Mothers in Hulu Langat, Malaysia

Effect of a Theory-Based Health Education Intervention on Safe Infant Sleep Practices to Reduce Sudden Infant Death Syndrome (SIDS) Among Pregnant Mothers Attending Maternal and Child Health (MCH) Clinics Under PKD Hulu Langat

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250805001
Enrollment
308
Registered
2025-08-05
Start date
2025-06-13
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden infant death syndrome Unsafe infant sleep practices Maternal health behavior Infant mortality prevention Safe infant sleep SIDS Pregnant mothers Health education IMB model Maternal and child health Behavioral intervention Cluster randomized trial Malaysia Antenatal care

Interventions

A structured, theory-based health education intervention delivered as a 2-hour face-to-face group workshop during antenatal visits. The program is based on the Information-Motivation-Behavioural Skill
Experimental Behavioral,No Intervention No treatment
SLEEP-BIM Health Education Workshop,Waitlist Control (Standard Antenatal Care)

Sponsors

Universiti Putra Malaysia
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged 18 to 49 years Gestational age between 24 and 32 weeks at recruitment Receiving antenatal care at selected MCH clinics under PKD Hulu Langat Able to read and understand Malay or English Malaysian citizen Resident of Hulu Langat or has lived in the district for at least 6 months Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: Diagnosed psychiatric illness or cognitive impairment that may affect participation or comprehension

Design outcomes

Primary

MeasureTime frame
Safe Infant Sleep Practices Baseline (T0), Immediately Post-Intervention (T1), 3 Months Post-Intervention (T2) Validated self-administered questionnaire with 11 items using a 3-point Likert scale

Secondary

MeasureTime frame
Knowledge on SIDS and Safe Infant Sleep Baseline T0, Post Intervention T1, Three Months Follow-up T2 Validated questionnaire with 22 items on risk factors and protective behaviours scored as correct or incorrect,Attitudes toward Safe Infant Sleep Practices Baseline T0, Post Intervention T1, Three Months Follow-up T2 Validated Likert-scale questionnaire assessing maternal attitudes towards recommended safe sleep behaviours,Beliefs about Safe Infant Sleep Practices Baseline T0, Post Intervention T1, Three Months Follow-up T2 Validated Likert-scale questionnaire assessing personal and cultural beliefs regarding safe and unsafe infant sleep practices,Self-Efficacy in Practicing Safe Infant Sleep Baseline T0, Post Intervention T1, Three Months Follow-up T2 Validated Likert-scale questionnaire measuring maternal confidence to implement safe sleep practices

Countries

Malaysia

Contacts

Public ContactAnisah Baharom

Universiti Putra Malaysia

b_anisah@upm.edu.my60389472582

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026