Evidence map›Paper›PMID 30018101›Full record

ArticleBMJ open2018

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 D Tran, David B Hipgrave, Sarah Hanieh, Ha Tran, Julie Simpson, Trang Nguyen, Minh Le and 1 more

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. Support for healthy breastfeeding mothers with healthy term babies.The Cochrane database of systematic reviews · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Jane FisherSchool of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
Tuan TranResearch and Training Centre for Community Development, Hanoi, Vietnam.
Stanley LuchtersSchool of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
Thach D TranSchool of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
David B HipgraveNew York Headquarters, United Nations Children's Fund, New York City, New York, USA.
Sarah HaniehDepartment of Medicine and Victorian Infectious Diseases Service, Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.
Ha TranResearch and Training Centre for Community Development, Hanoi, Vietnam.
Julie SimpsonMelbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia.
Trang NguyenSchool of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
Minh LeSchool of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
Beverley-Ann BiggsDepartment of Medicine and Victorian Infectious Diseases Service, Doherty Institute, University of Melbourne, Melbourne, Victoria, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOptimal 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.

Indexed as

Child DevelopmentInfant HealthLearningMaternal HealthSelf-Help GroupsSocial SupportAnemiaAnxietyChild, PreschoolDepressionDepression, PostpartumFemaleFetal Growth RetardationHumansInfantInfant, NewbornIodineEarly Childhood DevelopmentEmpowermentGender Based ViolenceMaternalMental Health

Identifiers

PMID30018101
PMCPMC6059326

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.