Mobile app plus counseling to promote exclusive breastfeeding and healthy infant feeding in Karachi
Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan: A Randomized Controlled Trial
This trial will test whether a smartphone coaching app combined with face-to-face counseling helps pregnant women in Karachi exclusively breastfeed for six months and follow recommended young child feeding practices.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 48 Years |
| Sex | Female |
| Sponsor | Aga Khan University Academic / other |
| Locations | 1 site (Karachi, Sindh) |
| Trial ID | NCT05590351 on ClinicalTrials.gov |
What this trial studies
The trial enrolls pregnant women in their third trimester from Aga Khan secondary care hospitals who have a smartphone and plan to remain in the area for at least one year. Participants receive an m-health coaching application alongside face-to-face counseling delivered through affiliated Family Health Centers, with follow-up during routine vaccination and growth-monitoring visits. Primary outcomes include rates of exclusive breastfeeding and adoption of young child feeding practices, with secondary monitoring of infant growth up to one year. The intervention targets urban low- and middle-income mothers to address high local rates of stunting, underweight and wasting.
Who should consider this trial
Good fit: Pregnant women at about 36 weeks gestation who can read Urdu or English, have a smartphone with internet, plan to deliver at an Aga Khan secondary care hospital, and intend to stay in the area for at least one year are ideal candidates.
Not a fit: Women with high-risk pregnancies (e.g., major maternal disease, multiple gestation), infants needing NICU care, those without smartphone access, or those planning to move away are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could increase exclusive breastfeeding and improve infant feeding practices, reducing early-life malnutrition and its long-term consequences.
How similar studies have performed: Previous mHealth and counseling interventions in low-resource settings have shown modest improvements in exclusive breastfeeding and complementary feeding, but results have varied by context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Karachi, Sindh
- The Aga Khan University — Karachi, Sindh, Pakistan (Recruiting)
Study contacts
- Principal investigator: Rozina Nuruddin, PhD — Agha Khan University
- Study coordinator: Rozina Nuruddin, PhD
- Email: rozina.nuruddin@aku.edu
- Phone: +923331288584
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.