Fisher 2018.

Study name	Addressing multiple modifiable risks through structured community‐based Learning Clubs to improve maternal and infant health and infant development in rural Vietnam
Methods	Study design: cluster‐RCT Country: Vietnam
Participants	Pregnant women Inclusion criteria:  a. all women who are aged at least 18 years, pregnant and less than 20 weeks’ gestation (determined on the basis of the first day of the last menstrual period) living in the selected communes Exclusion criteria: a. women who have a cognitive disability (determined by the local commune health station staff) or other serious physical disabilities which prohibit attendance Stated purpose: to assess the effectiveness of an 18‐month, 20‐module, structured, facilitated women’s health and early childhood development Learning Clubs intervention in reducing deficient cognitive development amongst 2‐year‐olds in rural Vietnam
Interventions	Intervention: Learning Clubs intervention The Learning Clubs intervention is a structured programme that combines perinatal stage‐specific essential information, learning activities and social support in accessible facilitated community‐based groups of women. The intervention comprises 20 educational modules, delivered in face‐to‐face groups at a community centre and in one home visit. The evidence‐informed content has been drawn from interventions to address individual risks: maternal nutrition, mental health or parenting capabilities, infant health and/or development or gender‐based violence and empowerment: Thinking Healthy, What Were We Thinking, Sisters for Life and Care for Child Development programmes and WHO guidelines for nutrition and breastfeeding. The programme will be implemented in facilitated small groups of women meeting every 2 weeks in community centres from mid‐pregnancy and every 4 weeks after childbirth, until the end of the first postpartum year (a total of 19 facilitated group sessions) and one home visit during the first eight postpartum weeks. Control: Usual care (usual standard of pregnancy and postpartum healthcare, including free antenatal checks, birth in a medical facility and access to the National Growth Monitoring and Expanded Immunisation Programmes)
Outcomes	Participants'outcomes of interest for this review Mental health symptoms/depression – Depression Anxiety and Stress Scale 21 items (DASS‐21) Mental health symptoms/anxiety – Depression Anxiety and Stress Scale 21 items (DASS‐21) Economic outcomes Cost‐effectiveness (calculate the direct and indirect costs of implementing the Learning Clubs programme compared with the cost of the usual standard of care; benefits of the intervention; incremental cost‐effectiveness ratio (ICER); economic and social return on investment (ROI). See Nguyen 2019) Time points: baseline, post‐intervention (F1: late pregnancy (32 weeks of gestation); F2: when infant is 1 year old; F3: when toddler is 2 years old)
Starting date	May 2018 (trial recruitment)
Contact information	Jane Fisher, jane.fisher@monash.edu
Notes	Source of funding: Australian National Health and Medical Research Council Project Grant (GNT1100147) and seed funding from Grand Challenges Canada under the Saving Brains Initiative (2014‐2015) Prospective trial registration number: ACTRN12617000442303