The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000442303
Ethics application status
Approved
Date submitted
31/10/2016
Date registered
27/03/2017
Date last updated
27/03/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Learning Clubs to improve women's perinatal health and early childhood development
Scientific title
Learning Clubs to improve women’s health and infant’s health and development in Vietnam: a cluster randomised controlled trial of a low-cost, evidence-informed, structured intervention.
Secondary ID [1] 289647 0
None
Universal Trial Number (UTN)
To be added when available
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perinatal common mental disorders among women 299445 0
Cognitive Development of two-year olds 299446 0
Maternal anaemia 300969 0
Maternal iodine deficiency 300970 0
Maternal anthropometric indices 300971 0
Maternal exposure to intimate partner violence 300972 0
Motor development of two-year olds 300973 0
Social-Emotional development of two-year olds 300974 0
Anthropometric indices of two-year olds 300975 0
Infant anaemia 302593 0
Infant microbiome 302594 0
Maternal iron deficiency 302621 0
Condition category
Condition code
Public Health 299426 299426 0 0
Health promotion/education
Reproductive Health and Childbirth 300772 300772 0 0
Antenatal care
Reproductive Health and Childbirth 300773 300773 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A novel, evidence-informed, psycho-educational intervention: Learning Clubs for Women's Health and Infant Health and Development. The intervention comprises 20 educational modules, delivered in face-face groups at a community centre and in one home visit. All content is drawn from interventions shown in RCTs in resource-constrained settings to be effective in addressing either maternal nutrition, mental health, parenting capabilities, infant health and development, or gender-based violence and empowerment. These include the Thinking Healthy, What Were We Thinking, Sisters for Life and Care for Child Development programs; and World Health Organization (WHO) guidelines on nutrition and breastfeeding. Nutritional messages will be based on WHO recommendations including e-Library of Evidence for Nutrition Actions and Essential Nutrition Action, and include dietary diversity, the use of supplements and fortified foods, and the importance of adequate nutritional intake. Messages about water, sanitation and hygiene will use materials from the Water, Sanitation and Hygiene (WASH) program. These will be adapted to be consistent with current national perinatal programs in Vietnam and to be culturally appropriate for Vietnamese women.

Each session will be facilitated by a member of the local Women's Union, who has had experience in conducting community programs and will also receive training specific to this trial. When required, a community health worker and/or a kindergarten teacher will also participate.

Each module will increase perinatal stage-specific essential knowledge and skills though structured learning activities that have been translated, culturally adapted and field-tested for salience and comprehensibility. The program will be implemented in facilitated small groups of women meeting every two to four weeks in community centres from early pregnancy until the end of the first postpartum year (a total of 19 facilitated sessions) and one home visit during the first eight postpartum weeks when mothers and infants in this setting usually do not go out of the house.

Each session will be from 60 to 90 minutes in duration, with shorter sessions scheduled for the first two postpartum meetings to accommodate infant feeding and sleeping requirements.

A typical session would include greeting the participants, recording attendance by Learning Club participants and any accompanying family members, weighing the participants to record pregnancy weight gain, asking the participants if they have any questions or concerns they'd like to discuss, introducing the current session and delivering the module content. Educational information will be given to the participants through the use of videos, short talks and participatory learning activities. These will be varied to maintain interest and will include short quizzes, physical exercises for pregnancy, practising breathing techniques for birth, observation of their babies to understand child development, demonstrations of caregiving for optimal child development, discussing and solving scenario-based exercises to understand and promote gender empowerment and mental health and prevent gender-based violence. During each session, take-home materials will be distributed to each participant. These materials will provide a summary of the information the participants are given at each session, recommended activities they can do at home and two take-home messages, one of which is to promote mental health and the other is to promote healthy nutrition.

A household visit will be conducted by a trained commune health station staff member. The purpose of the visit is to screen for postnatal complications and newborn warning signs and to guide women and their family members on how to soothe and settle the baby effectively and to promote the baby’s development through play and communication. Materials with summarised information, recommended activities and main messages for promoting mental health and healthy nutrition will be provided. The visit is expected to take 45 to 60 minutes.

As a whole the intervention will meet the 'five pillars' recommended by the World Health Organisation for programs to improve maternal and child health: family support, empathic listening, guided discovery using culturally appropriate images and text-based materials, behavioural activation and collaborative problem solving.

Intervention fidelity will be monitored by recording participants' attendance at each session. An attendance sheet will be distributed to each facilitator, who will record each participant's attendance at each session and whether there are any other family members joining her. In communes where the participation rate drops below 70%, facilitators in these communes will be contacted and participants' opinions will be sought to discuss if there are any problems or difficulties which may have led to a low participation rate that could be addressed.
Intervention code [1] 295267 0
Prevention
Intervention code [2] 295268 0
Behaviour
Comparator / control treatment
The control group will receive the usual standard of pregnancy and postpartum health care. This includes free antenatal checks, birth in a medical facility and access to the National Growth Monitoring and Expanded Immunisation Programmes.
Control group
Active

Outcomes
Primary outcome [1] 298894 0
The primary outcome is cognitive development, measured using the international gold standard - the Bayley Scales of Infant and Toddler Development, 3rd Edition, when children are two years old. Infants will be assessed by a team which is independent of the implementing team and will be blind to whether the children are from an intervention or a control commune, All measurements will be conducted by trained assessors.
Timepoint [1] 298894 0
24 months post-partum
Primary outcome [2] 300195 0
Symptoms of perinatal common mental disorders among women measured using the Depression, Anxiety and Stress Scale 21, Vietnam Validation. This scale was validated against gold-standard psychiatrist interviews to detect common mental disorders with high sensitivity and specificity.
Timepoint [2] 300195 0
Baseline, late pregnancy (32 weeks of gestation), 12 months post partum and 24 months post partum.
Secondary outcome [1] 325559 0
Infant anthropometric indices ascertained by trained assessors. Mother–infant scale (Seca 876); portable stadiometers & length boards (ShorrBoard) will be used to measure this outcome. Infant height-for-age, weight-for-age, and weight-for-height will be calculated by WHO methods using length and weight based on infant’s age and sex.
Timepoint [1] 325559 0
12 and 24 months post-partum
Secondary outcome [2] 325560 0
Infant Motor development assessed using the Bayley Scales of Infant and Toddler Development, 3rd Edition
Timepoint [2] 325560 0
12 and 24 months post-partum
Secondary outcome [3] 325561 0
Infant Cognitive development assessed using the Bayley Scales of Infant and Toddler Development, 3rd Edition
Timepoint [3] 325561 0
12 months post-partum
Secondary outcome [4] 329299 0
Infant Social-Emotional development. assessed using the Bayley Scales of Infant and Toddler Development, 3rd Edition
Timepoint [4] 329299 0
12 months post-partum
Secondary outcome [5] 329556 0
Maternal urinary iodine concentration will be assessed in urine samples. A casual urine sample of approximately 10 ml will be obtained from each participant in late pregnancy. Urine samples will be frozen in a field freezer and transported in a cold chain to the laboratory of the National Hospital of Endocrinology in Hanoi, who have conducted urine iodine concentration (UIC) analyses for many national surveys in Viet Nam. At the laboratory, UIC will be determined by means of the Sandell-Kolthoff reaction, as recommended by WHO, UNCEF and The International Council for the Control of Iodine Deficiency Disorders (ICCIDD). Iodine nutritional status is classified as adequate if UIC =150 µg/l) or deficient if UIC <150 µg/l according to the WHO/UNCEF/ICCIDD guidelines.
Timepoint [5] 329556 0
At 32 weeks of gestation
Secondary outcome [6] 329557 0
Maternal anaemia assessed through maternal haemoglobin (Hb) level. Maternal Hb level will be assessed using HemoCue 210. Hemoglobin (Hb) concentration will be evaluated in the field from a finger prick blood sample, using a hemoglobinometer (HemoCue AB, Angelholm Sweden). According to the recommendations by WHO and UNICEF, pregnant women are classified as having anaemia when Hb concentration < 11 g/dl.
Timepoint [6] 329557 0
Late pregnancy (32 weeks of gestation)
Secondary outcome [7] 330760 0
Maternal BMI calculated based on women’s height and weight. Women’s height will be measured using portable Shorr Boards (Shorr productions, Olney Md. USA) and women’s weight will be measured using electronic Seca 876 scales. BMI is calculated as weight in kilograms divided by height in metres squared.

Timepoint [7] 330760 0
Baseline, late pregnancy, 12 and 24 months postpartum
Secondary outcome [8] 330761 0
Gut microbiome profile of the child will be assessed by collecting a stool sample into a sterile container. Five grams of stool will be transferred into a sterile cryotube. The tube will be placed directly on ice before transfer to a -20C freezer. Then stools samples will be transferred to a -80C freezer then on dry ice to Australia and stored at -80C in the Peter Doherty Institute.
Timepoint [8] 330761 0
12 and 24 months of age..
Secondary outcome [9] 333015 0
Infant anaemia assessed through infant hemoglobin level using HemoCue 210. Hemoglobin (Hb) concentration will be evaluated in the field from a foot prick blood sample, using a hemoglobinometer (HemoCue AB, Angelholm Sweden). According to the recommendations by WHO and UNICEF, infants are classified as having anaemia when Hb concentration < 11 g/dl..
Timepoint [9] 333015 0
12 and 24 months of age
Secondary outcome [10] 333107 0
Maternal iron deficiency assessed through maternal serum ferritin. Venous blood samples of the mother will be collected by an experienced technician of the Vietnam National Institute of Hematology and Blood Transfusion; serum will be separated and frozen for transportation to Australia. Serum will be analysed for ferritin level by an accredited Australian laboratory. Iron deficiency is defined as serum ferritin level of <15ng/ml.
Timepoint [10] 333107 0
Late pregnancy (32 weeks of gestation)

Eligibility
Key inclusion criteria
All pregnant women of less than 20 weeks gestation living in the selected communes will be eligible to participate
Minimum age
16 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who have a cognitive disability or chronic illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. This trial will be conducted in Ha Nam, a rural province that has sufficient infrastructure to conduct this trial, represents the geographic zones of the North of Vietnam and does not have conflicting studies taking place. In the province, districts that are accessible to the research team by car will be selected and lists of communes from the selected districts made. In total 84 communes (unit of clustering) will be randomly selected from the lists and 42 will be allocated randomly to each study arm by an independent statistician.

In a process we have used successfully in prior studies, commune health centre staff and village health workers will identify and approach potential participants to inform them of the study and invite those who are interested to visit the commune health centre if they want to receive more information about the study. Those who are interested to participate will be recruited. The recruitment process will begin with 12 pregnant women per commune being randomly-selected from the list of eligible women. Each woman who declines the invitation to participate will be replaced by another randomly-selected woman until 12 are recruited per commune.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization to intervention or control conditions using a randomization table created by computer software (Stata 13).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Cluster randomization using the commune, which is the local primary government administrative entity, as the clustering unit
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The number of clusters and sample size have been calculated using the clustersampsi module in Stata, Version 13 (StataCorp LP, College Station, Texas, USA). A total of 1,008 pregnant women from 84 clusters (in each study arm: 504 women (12 women per commune (the cluster) recruited from 42 clusters) is necessary to detect a difference in the primary outcome (BSID cognitive development score < 1 SD at 2 years of age) of 15% in the control arm and 8% in the Learning Club intervention arm (with 80% statistical power and a significance level of 0.05; intra-cluster correlation coefficient [ICC] = 0.03). These assumptions are derived from previous studies in Vietnam and other resource-constrained settings. This sample size will give us = 85% power to detect differences between the two arms of the secondary outcomes. Sample size and power calculations take into account loss to follow-up from still births (0.2%), late abortions (1%), infant mortality (0.2%), relocation (5%) and withdrawal (13%), estimated together to be 20%.

After descriptive analyses, data will be analysed in two steps. First, the differences in the primary and secondary outcomes between the two arms will be estimated by individual-level analyses adjusting for clustering. Second, mixed-effect logistic regression for the main outcome and mixed-effect linear regression models for the secondary outcomes taking into account prognostic indicators and incorporating a random effect for commune (clustering) and a fixed effect for trial arm will be conducted to estimate the effects of the intervention on the outcomes. All analyses will follow intention-to-treat principles, applying multiple imputation for missing data, and be performed at individual level using Stata, Version 13 (StataCorp LP, College Station, Texas, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8020 0
Viet Nam
State/province [1] 8020 0
Ha Nam Province

Funding & Sponsors
Funding source category [1] 294034 0
Government body
Name [1] 294034 0
National Health and Medical Research Council
Address [1] 294034 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 294034 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 4, 553 St Kilda Rd, Melbourne, VIC 3004, Australia
Country
Australia
Secondary sponsor category [1] 292855 0
Other Collaborative groups
Name [1] 292855 0
Research and Training Centre for Community Development
Address [1] 292855 0
No 39 Lane 255, Vong Street, Hai Ba Trung District, Hanoi, Vietnam
Country [1] 292855 0
Viet Nam
Other collaborator category [1] 279336 0
University
Name [1] 279336 0
The University of Melbourne
Address [1] 279336 0
Department of Medicine,
Level 5, Peter Doherty Institute,
792 Elizabeth Street
Melbourne 3000
Country [1] 279336 0
Australia
Other collaborator category [2] 279337 0
Other Collaborative groups
Name [2] 279337 0
Burnet Institute
Address [2] 279337 0
85 Commercial Rd, Melbourne, VIC 3004, Australia
Country [2] 279337 0
Australia
Other collaborator category [3] 279338 0
Other Collaborative groups
Name [3] 279338 0
UNICEF
Address [3] 279338 0
UNICEF Headquarters
UNICEF House
3 United Nations Plaza
New York, New York 10017
U.S.A.
Country [3] 279338 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295446 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 295446 0
Room 111, Chancellery Building E, 24 Sports Walk, Monash Clayton Campus, Wellington Road, Clayton VIC 3800, Australia.
Ethics committee country [1] 295446 0
Australia
Date submitted for ethics approval [1] 295446 0
13/10/2016
Approval date [1] 295446 0
25/10/2016
Ethics approval number [1] 295446 0
2016-0683
Ethics committee name [2] 295447 0
Institutional Review Board of Hanoi School of Public Health
Ethics committee address [2] 295447 0
138 Giang Vo Str. , Ba Ðinh District, Ha Noi, Viet Nam
Ethics committee country [2] 295447 0
Viet Nam
Date submitted for ethics approval [2] 295447 0
15/11/2016
Approval date [2] 295447 0
Ethics approval number [2] 295447 0

Summary
Brief summary
Pregnant women in resource-constrained settings experience malnutrition, poverty, gender-based violence, depression and anxiety and inadequate access to health care and social protection, at much higher rates than women in high-income countries. We have shown in rural Vietnam that during pregnancy, women experience high rates of food insecurity, iodine deficiency, iron deficiency anaemia, intimate partner violence and common mental disorders.

The goal of this project is to improve the physical and mental health of women and the health and development of their infants in this resource-constrained setting, by addressing multiple risks together. This research is a world-first cluster-randomised controlled trial of a complex intervention addressing women’s physical and mental health, their parenting capabilities, infant health and development, and gender-based violence and empowerment in a resource-constrained setting. If shown to be effective it will provide robust evidence to inform national, regional and international policies and practices to optimise the health of the poorest women and the early development of their children in Vietnam and internationally.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67322 0
Prof Jane Fisher
Address 67322 0
Monash University
Level 4, 553 St Kilda Road,
Melbourne VIC 3004
Country 67322 0
Australia
Phone 67322 0
+61 3 9903 0290
Fax 67322 0
None
Email 67322 0
jane.fisher@monash.edu
Contact person for public queries
Name 67323 0
Prof Jane Fisher
Address 67323 0
Monash University
Level 4, 553 St Kilda Road,
Melbourne VIC 3004
Country 67323 0
Australia
Phone 67323 0
+61 3 9903 0290
Fax 67323 0
None
Email 67323 0
jane.fisher@monash.edu
Contact person for scientific queries
Name 67324 0
Dr Thach Duc Tran
Address 67324 0
Monash University
Level 4, 553 St Kilda Road,
Melbourne VIC 3004
Country 67324 0
Australia
Phone 67324 0
+61 3 9903 0626
Fax 67324 0
None
Email 67324 0
thach.tran@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results