Addressing multiple modifiable risks through structured community-based Learning Clubs to improve maternal and infant health and infant development in rural Vietnam: protocol for a parallel group cluster randomised controlled trial

Jane Fisher, Tuan Tran, Stanley Luchters, Thach Tran, David Hipgrave, Sarah Hanieh, Tran Thi Thu Ha, Julie Simpson, Trang Nguyen, Minh Le, Beverley-Ann Biggs

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2 Citations (Scopus)


Introduction Optimal early childhood development is an international priority. Risks during pregnancy and early childhood have lasting effects because growth is rapid. We will test whether a complex intervention addressing multiple modifiable risks: maternal nutrition, mental health, parenting capabilities, infant health and development and gender-based violence, is effective in reducing deficient cognitive development among children aged two in rural Vietnam. Methods and analysis The Learning Clubs intervention is a structured programme combining perinatal stage-specific information, learning activities and social support. It comprises 20 modules, in 19 accessible, facilitated groups for women at a community centre and one home visit. Evidence-informed content is from interventions to address each risk tested in randomised controlled trials in other resource-constrained settings. Content has been translated and culturally adapted for Vietnam and acceptability and feasibility established in pilot testing. We will conduct a two-arm parallel-group cluster-randomised controlled trial, with the commune as clustering unit. An independent statistician will select 84/112 communes in Ha Nam Province and randomly assign 42 to the control arm providing usual care and 42 to the intervention arm. In total, 1008 pregnant women (12 per commune) from 84 clusters are needed to detect a difference in the primary outcome (Bayley Scales of Infant and Toddler Development Cognitive Score <1 SD below standardised norm for 2 years of age) of 15% in the control and 8% in the intervention arms, with 80% power, significance 0.05 and intracluster correlation coefficient 0.03. Ethics and dissemination Monash University Human Research Ethics Committee (Certificate Number 20160683), Melbourne, Victoria, Australia and the Institutional Review Board of the Hanoi School of Public Health (Certificate Number 017-377IDD- YTCC), Hanoi, Vietnam have approved the trial. Results will be disseminated through a comprehensive multistranded dissemination strategy including peer-reviewed publications, national and international conference presentations, seminars and technical and lay language reports. Trial registration number ACTRN12617000442303; Pre-results. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Original languageEnglish
Article numbere023539
Number of pages13
JournalBMJ Open
Issue number7
Publication statusPublished - Jul 2018


  • Early Childhood Development
  • Empowerment
  • Gender Based Violence
  • Maternal
  • Mental Health

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