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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000520932
Acronym
Suanhoam: SUpporting Action on Nutrition in the HOme And coMmunity
Enrollment
223
Registered
2020-04-28
Start date
2020-12-17
Completion date
2022-09-30
Last updated
2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Burnet MacFarlane Institute
Lead SponsorOther Collaborative groups

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

Pregnant women in their third trimester (from 28-32 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 December 2020 to 30 November 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 31 January 2021 to 1 January 2022 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)

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026