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Trial registered on ANZCTR


Registration number
ACTRN12620000520932
Ethics application status
Approved
Date submitted
23/12/2019
Date registered
28/04/2020
Date last updated
28/04/2020
Date data sharing statement initially provided
28/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Suanhoam: a cluster-randomized controlled trial to evaluate the effectiveness of a mixed intervention package in reducing child undernutrition in Lao People's Democratic Republic
Scientific title
Integrated solutions for healthy birth, growth and development: a cluster-randomized controlled trial to evaluate the effectiveness of a mixed nutrition intervention package in reducing child undernutrition in Lao People's Democratic Republic
Secondary ID [1] 299614 0
None
Universal Trial Number (UTN)
Trial acronym
Suanhoam: SUpporting Action on Nutrition in the HOme And coMmunity
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stunting 314966 0
wasting 314967 0
underweight 314968 0
undernutrition 314969 0
low birth weight 314970 0
maternal undernutrition 314971 0
Condition category
Condition code
Public Health 313309 313309 0 0
Health promotion/education
Diet and Nutrition 313310 313310 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 313311 313311 0 0
Breast feeding
Reproductive Health and Childbirth 313312 313312 0 0
Antenatal care
Reproductive Health and Childbirth 313313 313313 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This cluster-randomized controlled trial has a control and an intervention arm.

The Control Arm will receive the standard primary health care services at their respective centres as mandated by the Ministry of Health. These standard activities include an ongoing drug revolving fund, health promotional materials developed by the Ministry, antenatal care (at least four visits during pregnancy), child immunizations (as per national guidelines), maternal weekly supplementation of Vitamin B1, iron and folic acid (for three months) and biannual child deworming - all services delivered by the front-line government health service staff.

The Intervention Arm will include all the standard package services plus an additional community nutrition component. This will include five nutrition-specific elements delivered by either the trained community nutrition teams in the villages at 2 to 4-month intervals or at 3-monthly outreach visits to the village by health centre staff.

The additional intervention community nutrition elements include the following:

1. Outreach days -
• These are health outreach clinics whereby health centre staff travel to a village to deliver clinical and health promotion services with the support of the community nutrition team in each village.
• These services will be delivered every 3 months using interactive and adult participatory approaches lasting 1-2 hours.
• For children aged less than 5 years, these services will include immunisations in accordance with the Lao national immunisation schedule, and growth monitoring
• Pregnant women and their partners will receive health advice about warning signs during pregnancy, antenatal and postnatal care, promotion of delivering in health facilities, and nutrition during pregnant and lactation
• Caregivers of children aged less than 5 years will receive nutrition and health advice specific to their needs and interests, such as information about young infant and child feeding, promotion of safe food preparation and storage (for caregivers of children under 5 years) and home management of childhood illness and undernutrition.
• This component will be monitored through a standardised report provided by outreach team documenting vaccines delivered, number of children having anthropometric assessments, and number of caregivers attending health promotion discussions.

2. Breastfeeding promotion –
• This component will be delivered by community nutrition teams in their own village in one-on-one and small group discussions with pregnant women and caregivers of children under 5 years
• These conversations will be an ongoing activity with community nutrition teams to provide advice to caregivers of young children as asked, but with a minimum of a 1hr session every 2 months
• Community nutrition teams will cover topics such as early initiation of breastfeeding, exclusive breastfeeding up to six months (including discussion of the common practice of feeding young infants pre-masticated rice), continued breastfeeding until 24 months and addressing breastfeeding taboos
• This activity will be monitored through diaries of contacts with caregivers kept by the community nutrition teams and validated through serial questionnaires of mothers (at the birth of the child and when the child is 6, 12 and 18 months of age).

3. Community-based nutrition education
• This component will be delivered by community nutrition teams in their own village in one-on-one and small group discussions with pregnant women and caregivers of children under 5 years
• These conversations will be an ongoing activity with community nutrition teams to provide advice to caregivers of young children as asked, but with a minimum of a 1hr session every 2 months
• Community nutrition teams will cover topics such as complementary feeding, continued breast feeding, dietary diversity, sources of micronutrients and addressing food taboos
• This activity will be monitored through diaries of contacts with caregivers kept by the community nutrition teams and validated through serial questionnaires of mothers (at the birth of the child and when the child is 6, 12 and 18 months of age).

4. Safe food preparation and storage
• This component will be delivered by community nutrition teams in their own village in one-on-one and small group discussions with pregnant women and caregivers of children under 5 years
• These conversations will be an ongoing activity with community nutrition teams to provide advice to caregivers of young children as asked, but with a minimum of a 1hr session every 2 months
• Community nutrition teams will cover topics such sourcing clean water and boiling water for drinking, cooking meat thoroughly, washing fruits and vegetables before eating, covering food set aside and promotion of handwashing practices
• This activity will be monitored through diaries of contacts with caregivers kept by the community nutrition teams and validated through serial questionnaires of mothers (at the birth of the child and when the child is 6, 12 and 18 months of age).

5. Home management of childhood illness and undernutrition
• This component will be delivered by community nutrition teams in their own village in one-on-one and small group discussions with pregnant women and caregivers of children under 5 years
• These conversations will be an ongoing activity with community nutrition teams to provide advice to caregivers of young children as asked, but with a minimum of a 1hr session every 4 months
• Community nutrition teams will cover topics such as recognising danger signs of community illnesses and when to take the child to a health centre, home management of mild diarrhoea, continued breastfeeding of the sick child, improved complementary feeding during illness, and guidance of supplementary feeding for moderately malnourished children
• This activity will be monitored through diaries of contacts with caregivers kept by the community nutrition teams and validated through serial questionnaires of mothers (at the birth of the child and when the child is 6, 12 and 18 months of age).

The duration of the intervention period will be from enrolment of a pregnant women at any time during the third trimester until the child to be born is 18 months of age - a maximum period of 21 months in total for each parent-child dyad.
Intervention code [1] 315907 0
Prevention
Intervention code [2] 315908 0
Early detection / Screening
Intervention code [3] 315909 0
Behaviour
Comparator / control treatment
The Control group will be those allocated into the 'Control Arm' (using minimisation) and who receive the standard treatment as described in the 'Descriptions of intervention(s)/exposure' section above.
Control group
Active

Outcomes
Primary outcome [1] 321795 0
WHO interprets stunting (height-for-age ) by using the Z-score classification system. The Z-score system expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value.

For stunting, this is defined as:

Z-score (or SD-score) for height-for-age = (observed value - median value of the reference population) / standard deviation value of reference population

The Z-score is widely recognised as the best system for analysis and presentation of anthropometric data. Z-scores will be calculated for each individual participant at ages 6, 12 and 18 months.

Reference: https://www.who.int/nutgrowthdb/about/introduction/en/index4.html

The primary outcome is the population prevalence of stunting among children aged 6, 12 and 18 months as determined by the WHO definition of a Z-score of height-for-age less than -2.
Timepoint [1] 321795 0
For the primary outcome of stunting in children, anthropometric assessment of children (length/height and weight) measured at age 6 months with the measures repeated again at 12 and 18 months. Sample size calculations are based on the prevalence of stunting among enrolled children at 18 months of age (which is the primary timepoint and primary endpoint).

An initial assessment of the height/length and weight of children will also be made as soon as possible after birth. We aim to conduct this assessment of children within 24 hours of birth. However, this assessment may be delayed for children born at home. For this reason, this measure will not constitute the primary timepoint.
Secondary outcome [1] 376237 0
Prevalence of low birth weight as measured with a Sec Digital Baby Scale within 24 hours of birth
Timepoint [1] 376237 0
Baby within 24 hours of birth
Secondary outcome [2] 376238 0
WHO interprets wasting (weight-for-height ) by using the Z-score classification system. The Z-score system expresses the anthropometric value as a number of standard deviations or Z-scores below or above the reference mean or median value.

For WASTING, this is defined as:

Z-score (or SD-score) for weight-for-height = (observed value - median value of the reference population) / standard deviation value of reference population

The Z-score is widely recognised as the best system for analysis and presentation of anthropometric data. Z-scores will be calculated for each individual participant at ages 6, 12 and 18 months.

Reference: https://www.who.int/nutgrowthdb/about/introduction/en/index4.html

The secondary outcome is the population prevalence of wasting among children aged 6, 12 and 18 months as determined by the WHO definition of a Z-score of weight-for-height less than -2.
Timepoint [2] 376238 0
When child is 6, 12, and 18 months old.

Eligibility
Key inclusion criteria
Pregnant women in their third trimester (from 28 weeks gestation):
o Identified in study villages in Vientiane province
o Aged 16 years and over
o During a 12 month recruitment period (from 1 February 2020 to 31 January 2021); and
o Who plan to stay in the village for at least 24 months following recruitment (to enable data to be collected until their new child is 18 months of age)

Children born to these women:
o Estimated to be during the 12 month recruitment period from 30 March 2020 to 1 March 2021
o Who plan to stay in the village for 18 months following birth (to enable data to be collected until the child is 18 months of age)
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnant women / newborn children who plan to permanently move out of Vientiane province during the study period
• Pregnant women who have a stillbirth
• Women whose child dies during the study period

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
An independent senior biostatistician from the University of Western Sydney, not involved in the study and blind to the identity of the health centre catchment (clusters) areas, will randomly allocate clusters to either receiving the intervention or not using the OxMaR minimisation software. This software allocates clusters using an algorithm that incoporates five cluster characteristics (see sequence generation below). The nature of the computation involved in minimisation means that neither the independent senior biostatistician nor the study researchers can predict the allocation of a cluster in advance. (The software automatically emails the principal investigator the outcome of each allocation, providing a record of all cluster allocations.)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central dynamic (adaptive) random allocation using Minimisation with health centre catchment (cluster) characteristics employed to assign clusters to different arms of the study.

This process used a freely available web-based minimisation algorithm called OxMar [O’Callaghan CA (2014) OxMaR: Open Source Free Software for Online Minimization and Randomization for Clinical Trials. PLoS ONE 9(10): e110761. doi:10.1371/journal.pone.0110761].

Assignment of clusters to intervention / control arms using a minimisation process incorporating 5 health centre catchment (cluster) characteristics:
1. ethnicity;
2. size of health centre catchment area;
3. median distance of villages in health centre catchment area to the district hospital;
4. proportion of households with latrines;
5. proportion of households classified as poor according to the Government of Lao PDR.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Data analysis will be by intention to treat.
Analyses for the primary and secondary outcomes will be conducted at the mother-infant dyad level, but will be adjusted for the cluster randomisation. The difference in prevalence of low birth weight, wasting and stunting between control and intervention groups will be assessed using Pearson’s chi-square tests and 95% confidence intervals for the group difference, adjusted for clustering. The relationship between prevalence and intervention, adjusted for other factors, will also be assessed using multivariable logistic regression along with generalised estimating equation to account for within cluster variability. STATA® software version 13 will be used for these analyses, with “xtgee” command along with “binomial family” and “logit link”. All the tests will be two-sided, and p-value <0.05 will be considered statistically significant.

For the economic analyses, all villages that are part of the intervention clusters will be assummed to be in the intervention arm and subsequent maternal-child health resource use (including costs for staff training) and outcomes for all villages will be analysed. The same will apply for the control group clusters. Primary analysis for costs will be unadjusted but secondary cost analysis will include covariates at the cluster level. The costs for training will be amortised over the intervention group for the full 18 months, but modeling as part of sensitivity analysis will take account of worker attrition and the frequency of training updates required over a period beyond 18 months.

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] 21964 0
Lao People's Democratic Republic
State/province [1] 21964 0
Vientiane

Funding & Sponsors
Funding source category [1] 304091 0
Government body
Name [1] 304091 0
National Health and Medical Research Council
Address [1] 304091 0
414 La Trobe Street, Melbourne, Victoria, 3000
Country [1] 304091 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Burnet MacFarlane Institute
Address
85 Commercial Road, Melbourne, Victoria, 3004
Country
Australia
Secondary sponsor category [1] 304341 0
University
Name [1] 304341 0
Lao Tropical and Public Health Institute
Address [1] 304341 0
Samesenthai Road, Ban Kaognot, Sisattanack District, Vientiane Capital
Country [1] 304341 0
Lao People's Democratic Republic
Secondary sponsor category [2] 304342 0
University
Name [2] 304342 0
Deakin University
Address [2] 304342 0
221 Burwood Highway, Burwood, Victoria, 3125
Country [2] 304342 0
Australia
Secondary sponsor category [3] 305972 0
University
Name [3] 305972 0
Western Sydney University
Address [3] 305972 0
Second Avenue, Penrith, NSW, 2727
Country [3] 305972 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304580 0
Alfred Health Ethics Committee
Ethics committee address [1] 304580 0
55 Commercial Road, Melbourne, Victoria, 3004
Ethics committee country [1] 304580 0
Australia
Date submitted for ethics approval [1] 304580 0
26/05/2016
Approval date [1] 304580 0
26/07/2016
Ethics approval number [1] 304580 0

Summary
Brief summary
The Lao People's Democratic Republic has one of the highest rates of stunting in children under 5 years in South East Asia. We propose a cluster-randomised control trial in catchment villages of health centres in remote, food-insecure districts of Vientiane Province to evaluate the effectiveness of a mixed nutrition intervention package in reducing child undernutrition. We will do this by comparing a control arm and an intervention arm. The control arm will receive a standard package of intervention as mandated by the Ministry of Health. The intervention arm will receive the standard package of interventions with an additional nutrition-specific package delivered by trained volunteer community nutrition teams. These interventions include growth monitoring, nutrition education and food preparation and storage (using the first 1000 days approach), and management of child illlness and undernutrition. The primary outcome measure is stunting in children aged 6, 12, and 18 months. The secondary outcome measures are low birth weight in newborns within 24 hours of birth, and wasting in children aged 6, 12, and 18 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97462 0
Dr Benjamin Coghlan
Address 97462 0
The MacFarlane Burnet Institute
85 Commercial Road, Melbourne, VIC, 3004
Country 97462 0
Australia
Phone 97462 0
+61 392822111
Fax 97462 0
Email 97462 0
ben.coghlan@burnet.edu.au
Contact person for public queries
Name 97463 0
Dr Benjamin Coghlan
Address 97463 0
The MacFarlane Burnet Institute
85 Commercial Road, Melbourne, VIC, 3004
Country 97463 0
Australia
Phone 97463 0
+61 392822111
Fax 97463 0
Email 97463 0
ben.coghlan@burnet.edu.au
Contact person for scientific queries
Name 97464 0
Dr Ben Coghlan
Address 97464 0
The MacFarlane Burnet Institute
85 Commercial Road, Melbourne, VIC, 3004
Country 97464 0
Australia
Phone 97464 0
+61 392822111
Fax 97464 0
Email 97464 0
ben.coghlan@burnet.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Local government permissions to conduct the study are contingent on not releasing individual participant data
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Analytic code
How or where can supporting documents be obtained?
Type [1] 6261 0
Study protocol
Citation [1] 6261 0
Peer reviewed publication in preparation
Planned for submission in July 2020
Link [1] 6261 0
Email [1] 6261 0
Other [1] 6261 0
Attachment [1] 6261 0
Type [2] 6262 0
Statistical analysis plan
Citation [2] 6262 0
Link [2] 6262 0
Email [2] 6262 0
Other [2] 6262 0
The statistical analysis plan will made publicly available as soon as data collection is underway and the study protocol submitted for publication. It is anticipated that this will occur in July 2020.
Attachment [2] 6262 0
Type [3] 6263 0
Informed consent form
Citation [3] 6263 0
Link [3] 6263 0
Email [3] 6263 0
Other [3] 6263 0
The informed consent form will be made publicly available on institutional website in July 2020
Attachment [3] 6263 0
Type [4] 6264 0
Ethical approval
Citation [4] 6264 0
Link [4] 6264 0
Email [4] 6264 0
shan.huang@burnet.edu.au
Other [4] 6264 0
Available on requests made via email to the project's Research Officer Shan Huang.
Attachment [4] 6264 0
Type [5] 6265 0
Analytic code
Citation [5] 6265 0
Link [5] 6265 0
Email [5] 6265 0
shan.huang@burnet.edu.au
Other [5] 6265 0
Available on requests made via email to the project's Research Officer Shan Huang.
Attachment [5] 6265 0
Summary results
No Results