NCT05590351 Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan
| NCT ID | NCT05590351 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aga Khan University |
| Condition | Malnutrition, Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2026-02-02 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Early life nutrition is the key modifiable determinant of child growth, development, survival and diseases of adult onset. Pakistan ranks highest for neonatal mortality rate (44.2/1000 live births (LBs)) globally. One third of under-five deaths (74.9/1000 LBs) are attributable to high prevalence of stunting (38%), underweight (23%) and wasting (7%), greatly related to feeding practices. Given the low prevalence of exclusively breast fed (EBF) (48%) and use of minimum acceptable diet (13%), mitigation of early life nutritional risk through promotion of EBF and Young Child Feeding Practices (YCFP) provides a critical window of opportunity for intervention. Secondary Care Hospitals (SCH) of the Aga Khan Health Services Pakistan provide essential maternal and child health services for low-middle income population. Babies born at these SCHs are followed up for vaccination, growth-monitoring and other services at the closely affiliated Family Health Centers (FHCs) run by Lady Health Visitors (LHVs). We aim to examine the effectiveness of a locally designed m-Health application for empowering mothers for child nutritional care as a potentially sustainable approach. The first six months of formative research would identify perceptions, barriers and facilitators for EBF and YCFP using self-determination behavioral theory, among multi-parous pregnant mothers enrolled at three SCHs of Karachi. A randomization trial would be conducted during next 18 months among near-term pregnant women who have access to smart-phones. A culturally appropriate mhealth application called first diet would be developed to provide personalized push messages delivered weekly by the LHVs. Non-intervention group will receive face-face nutritional counselling by the research staff at FHC following routine vaccination and growth-monitoring schedule. Mothers would followed-up from one month prior to expected delivery to child's first birthday. We expect 20% improvement in rates of EBF and YCFP with m-Health intervention. If proven effective, m-health would be incorporated in routine child care provision by LHVs.
Eligibility Criteria
Inclusion Criteria: 1. Pregnant women in the third trimester at 36 +/- 1 week of gestation. 2. Planned to stay in their respective areas for at least 1 year after delivery 3. Planned to get the infant immunized from the respective FHC of the hospitals. 4. Have access to smart phones with internet connection. 5. Registered and planning to deliver to any of the Secondary Care Hospitals 6. Can read and write in local language (English and/or Urdu). 7. Consent to participate and remain in the study until 1 year of child age Exclusion Criteria: 1. High-risk including maternal neurological/heart/ autoimmune/renal disease, preeclampsia, placenta previa, multiple gestations (twins/triplets), fetal structural/genetic anomalies, fetal growth restrictions, and birth trauma/requiring NICU admission. 2. Women who plan to move to different location after delivery
Contact & Investigator
Rozina Nuruddin, PhD
PRINCIPAL INVESTIGATOR
Agha Khan University
Frequently Asked Questions
Who can join the NCT05590351 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 48 Years, studying Malnutrition, Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05590351 currently recruiting?
Yes, NCT05590351 is actively recruiting participants. Contact the research team at rozina.nuruddin@aku.edu for enrollment information.
Where is the NCT05590351 trial being conducted?
This trial is being conducted at Karachi, Pakistan.
Who is sponsoring the NCT05590351 clinical trial?
NCT05590351 is sponsored by Aga Khan University. The principal investigator is Rozina Nuruddin, PhD at Agha Khan University. The trial plans to enroll 300 participants.