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Efficacy of Mobile Health Application in Promotion of Exclusive Breast Feeding and Young Child Feeding Practices in Pakistan

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2025 to Feb 2, 2026 · Primary endpoints: 8 to 2 · Enrollment target: 258 to 300 · 6 morev8 Show 9 more changesShow less
    • Start date changed from estimate of Apr 2025 to Feb 2, 2026
    • Primary endpoints: 8 to 2
    • Enrollment target: 258 to 300
    • Primary completion date: Dec 2026 to Jun 2027
    • Completion date: Mar 2027 to Dec 2027
    • Secondary endpoints: 8 to 14
    • Site details revised
    • Study title expanded, about 6 words
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Start date: Nov 2024 to Apr 2025v7
  4. Minor Study Identification, Study Status, Oversightv6
  5. Minor Secondary endpoints revised (8)v5 See this version in full on ClinicalTrials.gov ↗
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  1. Minor Secondary endpoints: 11 to 8v4 See this version in full on ClinicalTrials.gov ↗
  2. Minor Study description shortened, about 235 words Publications: 4 to 6v3 Show 1 more changeShow less
  3. Notable Primary completion date: Aug 2024 to Dec 2026 Start date: Aug 2023 to Nov 2024 · Completion date: Aug 2025 to Mar 2027 · Study description expanded, about 996 wordsv2 Show 3 more changesShow less
    • Start date: Aug 2023 to Nov 2024
    • Completion date: Aug 2025 to Mar 2027
    • Study description expanded, about 996 words

    See this version in full on ClinicalTrials.gov ↗

  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05590351
Lead Sponsor Aga Khan University
Conditions Malnutrition, Infant, Malnutrition, Child
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov