The Nutri-Lao Study Vilabouly and Sepon Districts Savannakhet

The Nutri-Lao Study Vilabouly and Sepon Districts Savannakhet

The Nutri-Lao Study Vilabouly and Sepon Districts Savannakhet Province 2016 2019 Funded by the Australian National Health and Medical Research Council Study 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 PDR , , : .

Research Partners Burnet Institute (Melbourne) Western Sydney University National Institute of Public Health (Vientiane) Deakin University (Melbourne) Monash University (Melbourne) Savannakhet Provincial Health Office Vilabouly & Sepon District Health Offices The silent crisis in Lao PDR Malnutrition in Lao PDR and Ethiopia Source: UNICEF Lao Office, 2006 Situation in 2010-12 15% of Lao newborns have a low birthweight (<2,500 gm), which is a strong predictor of poor child nutrition outcomes Source: UNICEF, World Bank and WHO Database, 2016 Preliminary research: (1) Qualitative research Qualitative studies on nutrition beliefs and behaviours among eight ethnic groups in Phongsali and Huaphan provinces Phunoi, Lue, Akha, Khmu, Lao, Hmong, Mien/Yao, and

Phuthai ethnic groups were studied Holmes, W, Hoy, D, Lockley, A, Thammavongxay, K, Bounnaphol, S, Xeuatvongsa, A, Toole, MJ. Influences on maternal and child nutrition in the highlands of northern Lao PDR. Asia Pacific J Clin Nutr 2007;16 (3):538-546. Main findings Most ethnic groups do not give colostrum to their babies. Most women routinely breastfeed. However, exclusive breastfeeding until four or six months of age is rare. Complementary foods are often given in the first few days of life, except among the Hmong and Akha. Some mothers stop breastfeeding when they are ill, although most continue. The duration of breast-feeding varies and is not associated with ethnicity. Most mothers feed their babies for one or more years; however, many mothers cease breast-feeding before one year. Child nutrition (continued) Malnutrition among children was reported by parents as being common, especially among the Akha. There are numerous locally available foods rich in nutrients that are not commonly given to young children, including several varieties of yellow fruit, peanuts, sesame seeds, beans, peas, eggs, and pork fat Food taboos are common in infancy although there is

variation within each ethnic group: Many ethnic groups, however, reported that they rarely give fruit to children There are also often food taboos for when a child is ill. Womens Nutrition Food taboos among women are less common and less widely adhered to during pregnancy than food taboos after delivery. The Akha appeared to be the group that most commonly had food taboos during pregnancy. Food taboos after childbirth are common in all ethnic groups. However, again, these are not always consistent between villages or even within villages of the same ethnic group. There is an impression that many food taboos are not deeply rooted in ethnic cultures but are rather localised traditions, often confined to the family or clan. Symptoms that indicate the possible presence of thiamine deficiency were also reported. Preliminary research: (2) Vilabouly pilot project Vilabouly District in Savannakhet province has a population of approximately 30,000 people and is the 36th poorest District in the country many belong to ethnic minorities.

100% of the households of Vilabouly District described as having inadequate rice, shelter and access to health care The project was in 12 villages and was funded by the LXML mining company Indicator National Stunting Vilabouly 2001 2006 42% 58% 33%

Wasting 7% 23% 19% Underweight 38% 51% 39% Coghlan B, Toole MJ, Chanlivong N, Kounnavong S, Vongsaiya K, Renzaho A. The impact on child wasting of a capacity building project implemented by community and district health staff in rural Lao PDR. Asia Pac J Clin Nutr 2014;23(1):105-111. Three-year pilot longitudinal descriptive study of 720 households in 12 villages in a district

of Savannakhet to assess the feasibility and acceptability of a mixed community-based nutrition-specific and nutrition-sensitive package Domains of health assessed in baseline (2008) and end-of-project (2011) surveys Vaccinations Childhood illnesses Maternal health issues Quantitative Household surveys Breastfeeding practices Family planning Water & sanitation (HIV knowledge) Mortality NUTRITION Qualitative

FGDs (Women/ Men) Observation Household intake (last 24hrs) Food eaten yesterday Number of times eaten 0 1 2 3 Rice 70 9 98.2 % 1.8% 0.6%

4.0% 93.1 % Bamboo 63 9 88.5 % 11.4 % 19.9 % 19.7 % 48.6 %

Green vegies 37 4 51.8 % 47.9 % 25.3 % 13.6 % 12.7 % Yellow vegies 13 4

18.6 % 81.2 % 9.8% 2.1% 6.5% Fish 32 7 45.3 % 54.4 % 25.2 %

7.8% 12.3 % Meat 28 6 39.6 % 60.2 % 19.5 % 8.3% 11.6 % Fruit

26 6 36.8 % 62.6 % 18.8 % 8.0% 10.0 % 2.5% 6.9% 1.7% 1.0% 1.0%

0.8% 13 18.4 Egg Types of food consumed: 3 % 81.0 9.0% % Almost 1 in 5 households only ate rice and/or bamboo 92.1 Corn 54 7.5% 4.7% 1 in 5 households had 3 types of food (usually rice + bamboo % + green vegetables or fish) 95.0 Peanut 35

4.8% 3.0% Project inputs Nutrition-specific: The project aimed to reduce acute malnutrition in children through the establishment of volunteer community nutrition teams in each village to monitor child growth and promote exclusive breastfeeding, healthy infant feeding practices and child diets. This project took place before the introduction of multiple micronutrient supplements for children were introduced into Savannakhet province. District health staff were trained to support these teams with monthly outreach to formally assess child growth and to manage severe acute malnutrition in children. Nutrition-sensitive: Outreach activities also aimed to increase immunization coverage, teach mothers how to manage children with diarrhoea, improve access to antenatal and postnatal care, and promote family planning. Project outcomes (2011) Feeding behaviours and child nutrition More new mothers fed their child soon after birth: 72% breastfed within 2hrs of delivery compared with 40% in 2008. Fewer women discarded the colostrum: 92% fed their baby colostrum, up from 69%. Fewer women fed their baby solids before 6 months: 41% down from 87% in 2008.

Far fewer children suffered from wasting: 12.4% of children were acutely malnourished in 2008 compared with just 5.3% in 2011 Other project outcomes Antenatal care More pregnant women could access antenatal care: 88% had at least 1 visit by a skilled health professional up from 69%, while 53% had 4 or more visits up from 32%. More pregnant women received supplements: 86% received iron tablets compared with 55% in 2008, and 79% received Vitamin B1 compared with 0%. Family planning A little over half of all women aged 15-45 years had received family planning advice in August 2008. This had increased to 69% during the evaluation in December 2011. Care during childbirth More women delivered at the district hospital: 52% had a baby at the hospital increased from 38%. Fewer women gave birth at home: 39% compare with 53%. More deliveries were attended by a trained health professional: 62% compared with 52% in 2008

Child immunizations More children have an immunization care: improving from 30% to 51%. More children received birth doses of BCG and hepatitis B: coverage of BCG vaccine went from 62% to 83%, and hepatitis B from 24% to 64%. More children are protected against measles: from 31% in 2008 to 87% in 2011. The pilot demonstrated the readiness of local authorities and communities to implement the interventions; showed that health services can be improved and that unsafe feeding practices can be changed; and suggested that the combination of interventions can improve the nutritional status of children. Nutri-Lao Study Primary Hypothesis: Compared with those in the control group (who will receive a standard primary health care package), the intervention package delivered to pregnant women from 6 months gestation and their infants until 18 months of age will reduce the prevalence of stunting

(height-for-age <-2 Z score) by 10% (44% control vs. 34% intervention) in children at 18 months of age. Secondary Hypotheses: The intervention package will reduce (i) the prevalence of LBW by 5% (control 11% vs intervention 6%) and (ii) the prevalence of wasting (weight-for-height <-2 Z score) by 6% (12% control vs. 6% intervention) in children at 18 months of age. Tertiary hypothesis: The mixed CBNP will be cost-effective compared to the standard PHC package currently implemented by the Lao Ministry of Health (MOH). Cluster randomised controlled trial A total of 22 health centres serving 204 villages (150 in Sepon and 54 in Vilabouly) with a total population of 77,027 residents will be included in the trial. Each HC catchment area will be considered a separate cluster for practical reasons. Each arm will include 102 villages. Based on GoL projections of the district population and district crude birth rate from 2005-2013 data, we anticipate that about 3,302 children will be born during the 12month enrolment phase across all 204 villages in 2016. We will enrol: (1) all pregnant women in the third trimester who plan to stay in the village for the next 21 months, this enrolment period will last 12 months; and (2) their infants born during this 12 month period and within approximately 3 months after the end of the enrolment period. Data collection Senior research manager and four field coordinators based in Vilabouly

We will measure primary and secondary outcomes at birth (birthweight only), 6, 12, and 18 months of age. Blood spots will be taken from pregnant women upon recruitment by HC staff for haemoglobin and malaria. The primary and secondary outcomes are expected to be mediated through a number of improvements in nutritional behaviours and health service coverage indicators. These variables will be measured (at the individual level and reported for clusters) using questionnaires based on the Lao Social Indicator Survey (2011-12). Casual data collectors will be recruited (for example, teachers and students) 22 (one per HC catchment area). The intervention will be delivered by staff from each intervention arm HC and the community nutrition team (CNT) in each village with oversight by multi-sectoral district project implementation teams (Health, Education, Agriculture, and Communications Departments, the District Governors Office, and the Lao Womens and Youth Unions). The CNTs will be developed and trained by the project and will include four members the village head or elder, village health volunteer (VHV), traditional birth attendant (TBA), and one HC staff. Both intervention and control villages will receive all seven standard PHC components either at the HC or during routine 4-monthly outreach. The intervention group will receive an additional six nutrition-specific components either from the CNT in the village or at 4-monthly visits by HC staff.

Table 1A: Standard PHC package for BOTH Control and Intervention Groups Component Target population HC staff Content Frequency Delivered by Site Drug and financial management Ongoing HC staff Village Local population Information on services

Ongoing HC staff HC Pregnant women Birth to 12 months Children 6-23 months Pre & postpartum (3m) Standard MOH package >= 4 visits HC staff HC BCG, DTP, Hep B, measles, OPV As per national guidelines

10 sachets per month Breastfeeding promotion and practices, weaning Pre, during and post postpartum, Breast feeding early initiation, exclusive breastfeeding, safe weaning, food taboos 1 session (1hr) every 3 months CNT Village Community-based nutrition education Parents of children aged

<5yrs Food groups, source of micronutrients, dietary diversity using local foods 1 session (2hrs) every 3 CNT months Village Cooking demonstrations Parents of children <5yrs Safe food preparation & storage 1 session (2hrs) every 3 CNT months Village

Home management of child illness and undernutrition Parents of children aged <5yrs Diarrhoea, ARI, undernutrition: how to identify signs and manage 1 session (1hr) every 4 months Village Drug revolving fund (DRF) Health promotion materials Antenatal care (ANC) HC & HC outreach

Multiple Micronutrient 15 vitamins and minerals, HC & Village (MMN) infant powders including Vitamin A, zinc and iron outreach Vitamin B1 & Iron/Folic Vitamin B1: 100 mg; Iron: 60 mg; Weekly HC & HC acid Folic acid: 400 ug outreach Every 6 HC & Deworming Children 6-59 m Mebendazole (500mg) Village months outreach Table 1B: Additional components for Intervention Group (Outreach in intervention villages will be once every 2 months) Children (<5yrs) Child immunisation; ANC and 1 day every 2 Clinical outreach days CNT, HC staff Village

& their parents newborn health; anthropometry months United Nations International MMN maternal Pregnant Multiple Micronutrient Bi-monthly HC staff HC supplements women Preparation Child immunisations CNT, HC staff Cascade-style train the trainer model At the district level, the project implementation teams (PIT) members will be trained by research staff in project management, supervision, data collection, financial management, communication, and reporting, as well as an overview of the intervention components. At the community level, the four participants (CNT) in each intervention village will undertake a series of modules in the form of one-day participatory workshops. Modules will cover nutrition education, cooking demonstrations, home fortified food supplementation with multiple micronutrients, home

management of child illness and undernutrition, antenatal and postnatal care, and bimonthly growth monitoring. Upon graduation, trained participants will implement the intervention using individual and group behaviour change communication techniques and outreach by HC staff Tertiary outcome cost-effectiveness analysis An economic evaluation will be conducted from the perspective of the Lao MOH. Outcome and resource/cost data will be prospectively collected at the HC and individual levels. The results will be based on the primary outcome measure and expressed as cost or saving per 5 percent change in the incidence of acute undernutrition in infants aged 18 months calculated from the differences in mean costs and outcomes between the intervention and control groups, to generate an incremental cost-effectiveness ratio (ICER). The outcome measures for the ICERs will be expressed as cost per 6% reduction in wasting and 10% reduction in stunting at 18 months. Timeline of project phasing Quarter (3 months) Q1 Q2 Phase 1 (start-up)

January-June 2016 Establish training facility; identify CNT, PIT and HC staff for training (3m) Training of PIT, CNT, HC staff and field coordinators (3m) Ethics approvals in Australia and Lao PDR Lao Government approval Q3 Q4 Q5 Q6 Phase 2 (enrolment)

Q7 Q8 Q9 Q10 Q11 Q12 Q13 Q14 Phase 4 Apr-June 2020 July 2016 September 2017 Data analysis Enrolment of pregnant women in 3rd trimester (12m)

Enrolment of infants at birth (12m) October 2016 March 2019 Phase 3: Intervention and data collection (30m) Measures of infants at birth (12m) Measures of children at 6, 12, and 18 months (anthropometry, etc.) Measures of mothers at birth (care during pregnancy & delivery, initiation of breast-feeding) Measures of mothers at 6, 12, and 18m (post-natal care, breastfeeding, weaning and complementary feeding practices, including dietary diversity, knowledge of home management of childhood illness) Process evaluations at 6-monthly intervals Write up Dissemination Dissemination of findings Dr Sengchanh (National Institute of Public Health) and Dr Panom Phongmany, the provincial health director of Savannakhet province, will lead GoL efforts to disseminate, adapt and scale up the findings of the proposed study if they demonstrate the cost-effectiveness of the community-based nutrition package. The National Nutrition Centre (MOPH) will be a key stakeholder.

Publication of the findings in peer-reviewed journals and dissemination through academic and development forums will ensure findings are disseminated beyond Lao PDR. A policy brief will be prepared for the Australian aid program which has established a multi-sectoral Nutrition Working Group and is currently in the process of developing a strategy to effectively address maternal and child undernutrition. Good reference Victora, Cesar G et al. Maternal and Child Undernutrition: Consequences for Adult Health and Human Capital. Lancet 371.9609 (2008): 340357. PMC. Web. 16 Mar. 2016. Based on data from cohorts followed up from birth into late adolescence or adult age in Brazil, Guatemala, India, the Philippines, and South Africa Height-for-age at 2 years of age the best predictor of human capital, defined as: Adult height Educational achievements Adult income For females: birthweight of offspring Poor foetal growth or stunting in the first 2 years of life leads to irreversible damage, including shorter adult height, lower attained schooling, reduced adult income, and decreased offspring birthweight Thank you

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