Learning Clubs to improve women's perinatal health and early childhood development

• Register: ANZCTR
• Last refreshed on: 21 February 2022
• Main ID: ACTRN12617000442303
• Date of registration: 27/03/2017
• Prospective Registration: Yes
• Primary sponsor: Monash University
• 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.
• Date of first enrolment: 20/04/2018
• Target sample size: 1008
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617000442303.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Viet Nam

Contacts

• Name: Prof Jane Fisher

• Name: Dr Thach Duc Tran

Key inclusion & exclusion criteria

Inclusion criteria: All pregnant women of less than 20 weeks gestation living in the selected communes will be eligible to participate
Exclusion criteria: Women who have a cognitive disability or chronic illness

Age minimum: 16 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Antenatal care

Public Health - Health promotion/education

Perinatal common mental disorders among women ;Cognitive Development of two-year olds;Maternal anaemia;Maternal iodine deficiency;Maternal anthropometric indices;Maternal exposure to intimate partner violence;Motor development of two-year olds;Social-Emotional development of two-year olds;Anthropometric indices of two-year olds;Infant anaemia;Infant microbiome;Maternal iron deficiency;
Perinatal common mental disorders among women
Cognitive Development of two-year olds
Maternal anaemia
Maternal iodine deficiency
Maternal anthropometric indices
Maternal exposure to intimate partner violence
Motor development of two-year olds
Social-Emotional development of two-year olds
Anthropometric indices of two-year olds
Infant anaemia
Infant microbiome
Maternal iron deficiency

Reproductive Health and Childbirth - Childbirth and postnatal care

Intervention(s)

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 facilitat

Primary Outcome(s)

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. [Baseline, late pregnancy (32 weeks of gestation), 12 months post partum and 24 months post partum. ]

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.[24 months post-partum]

Secondary Outcome(s)

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.

[Baseline, late pregnancy, 12 and 24 months postpartum]

Home environment will be assessed using the Infant/Toddler Home Observation for Measurement of the Environment (HOME) Inventory. This measure comprises 45 items grouped into six subscales assessing quality and quantity of stimulation and support available to a specific 0 – 24 month old child at home through direct observation and semi-structured parent interviews at home.[24 months of age]

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.[12 and 24 months post-partum]

Infant Cognitive development assessed using the Bayley Scales of Infant and Toddler Development, 3rd Edition[12 months post-partum]

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.
[Late pregnancy (32 weeks of gestation)]

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.[At 32 weeks of gestation ]

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..[12 and 24 months of age]

Infant Motor development assessed using the Bayley Scales of Infant and Toddler Development, 3rd Edition[12 and 24 months post-partum]

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.[Late pregnancy (32 weeks of gestation)]

Infant Social-Emotional development. assessed using the Bayley Scales of Infant and Toddler Development, 3rd Edition[12 months post-partum]

Secondary ID(s)

None

Source(s) of Monetary Support

National Health and Medical Research Council

Secondary Sponsor(s)

Research and Training Centre for Community Development

Ethics review

Status: Approved
Approval date: 25/10/2016
Contact:

Monash University Human Research Ethics Committee

Status: Approved
Approval date: 01/11/2017
Contact:

Institutional Review Board of Hanoi School of Public Health

Results

• Results available: Yes
• Date Posted: 09/02/2022
• Date Completed: 17/01/2021