A Community-based Cluster Randomized Controlled Trial to Evaluate the Effectiveness of Different Bundles of Nutrition-specific Interventions in Improving Mean Length-for-age Z Score Among Children at 24 Months of Age in Rural Bangladesh
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,880
- 试验地点
- 2
- 主要终点
- Change in Length-for-age Z scores (LAZ) at 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline LAZ at 7 days of birth.
研究概览
简要总结
Background:
- Burden: The prevalence of stunting among the under-five children in Bangladesh was >55% in 1997, which reduced to 41.9% in 2011. This reduction took 14 years to achieve with existing interventions, and till today Bangladesh remains among the countries with the highest stunting prevalence.
- Knowledge gap: In the Lancet series on Maternal and Child Nutrition, Bhutta et al (2013) modelled the effect of 10 direct interventions on lives saved and economic costs in 34 countries which contains 90% of the children with stunted growth. Their findings suggested that at 90% coverage, these interventions could cut down under-5 year mortality by 15% and avert one-fifth of stunting. The total additional annual cost was estimated at $9.6 billion. There is a dearth of primary research, however, to determine a feasible, effective bundle of interventions for developing countries.
- Relevance: This study will review and test different sets of nutrition-specific intervention bundles in a cohort of pregnant women and the subsequent impact on the length-for-age Z score (LAZ) of their offspring from that pregnancy.
Hypothesis: Five selected nutrition-specific interventions implemented during early pregnancy and during first two years of child's life in different bundles will cause a shift of 0.4 in mean LAZ score among children at 24 months of age compared to those in comparison arm.
Methods: The investigators propose a community-based randomized trial (cRCT) to evaluate the effectiveness of different combinations of the five selected nutrition-specific interventions and identify the best combination for improving childhood LAZ. Selected interventions include prenatal nutrient supplementation; intensive counselling on prenatal nutrition, exclusive breastfeeding and timely complementary feeding; and nutrient supplementation during 6-23 months of child's age. The proposed study area is Habiganj district, Sylhet division. 125 clusters (each ~2000 population or ~450 households) will be selected from 12 homogeneous unions in 2 adjacent sub-districts. The clusters will then be randomly assigned to any one of the 5 study arms. Data would be collected at baseline and followed up, including on nutritional intake and anthropometric measurements of mothers and offspring. Primary outcome measure/variable would be mean LAZ of offspring at 24 months. Secondary outcome variables include nutritional intake during pregnancy, maternal weight gain, exclusive breast feeding up-to 6 months, and birth weight.
Implications: The investigators expect that the results will serve to inform and shape future health policy decisions related to promotion of maternal and child health.
详细描述
Research Design and Methods
The investigators propose a community-based cluster randomized trial (cRCT) to evaluate the effectiveness of different combinations of 5 selected prenatal and post-natal nutrition-specific interventions in improving mean LAZ scores among 24 months old children. The interventions to be tested in different combinations are-:
- Prenatal nutrition-specific counselling
- Prenatal nutrient supplementation
- Intensive counselling of exclusive breast-feeding during postnatal first six months
- Nutrient supplementation for children during 6-23 months of age with continued breastfeeding
- Complementary feeding counselling. The three counselling interventions (Behaviour change communication, BCC) will be universal in all intervention arms and the two types of supplementation will be provided in different combinations explained elsewhere. This design will allow testing for synergy, and help to determine the effect size of selected individual interventions, such as evaluating how much effect supplementation (for mother and/or child) would have on improving length-for-age z score (LAZ).
The cohort of pregnant women and their children from that pregnancy will be followed-up over 32 months of the intervention period.
Sample Size Calculation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All new pregnancies in the selected clusters
- •Eligible woman is resident of the study area
- •Gestational age ≤125 days
- •Possible pregnant woman can identify her last menstrual period (LMP)
排除标准
- •Similar nutrition interventions currently being implemented by either public or non-government agency in the selected cluster
- •The cluster is too hard to reach and accessibility of the cluster is highly constrained by geographical impediments
- •The cluster includes tea gardens. Communities in tea gardens comprise of unique ethnicity, culture and lifestyle for which our intervention is not customized
研究组 & 干预措施
Arm 1: BCC+PNS+CNS
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth, along with a lipid-based nutrient supplement to pregnant women (PNS) till delivery. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children, along with a lipid-based nutrient supplement for children (CNS) aged 6m to 2 years.
干预措施: Nutrient supplement to pregnant women (PNS) (Dietary Supplement)
Arm 1: BCC+PNS+CNS
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth, along with a lipid-based nutrient supplement to pregnant women (PNS) till delivery. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children, along with a lipid-based nutrient supplement for children (CNS) aged 6m to 2 years.
干预措施: Nutrienr supplement to children 6m to 2 years (Dietary Supplement)
Arm 1: BCC+PNS+CNS
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth, along with a lipid-based nutrient supplement to pregnant women (PNS) till delivery. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children, along with a lipid-based nutrient supplement for children (CNS) aged 6m to 2 years.
干预措施: Nutrition-specific Behaviour change communication (BCC) (Behavioral)
Arm 2: BCC+PNS
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth, along with nutrient supplement to pregnant women (PNS) till delivery. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children.
干预措施: Nutrition-specific Behaviour change communication (BCC) (Behavioral)
Arm 2: BCC+PNS
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth, along with nutrient supplement to pregnant women (PNS) till delivery. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children.
干预措施: Nutrient supplement to pregnant women (PNS) (Dietary Supplement)
Arm 3: BCC+CNS
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children, along with nutrient supplement to children (CNS) 6m to 2 years.
干预措施: Nutrition-specific Behaviour change communication (BCC) (Behavioral)
Arm 3: BCC+CNS
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children, along with nutrient supplement to children (CNS) 6m to 2 years.
干预措施: Nutrienr supplement to children 6m to 2 years (Dietary Supplement)
Arm 4: BCC only
Pregnant women receive nutrition-specific behaviour change communication (BCC) counselling on health, nutrition, hygiene etc during pregnancy and on exclusive breastfeeding (EBF) till 6 months of children's birth. After birth, counselling continues on EBF, on nutrition of lactating mothers, and on health and associated issues of mothers and children. From 6 months of children's age, counselling is covered on timely complementary feeding and continued breastfeeding till 2 years of age, nutrition of lactating mother, health other associated issues of mothers and children.
干预措施: Nutrition-specific Behaviour change communication (BCC) (Behavioral)
Arm 5: comparison
No intervention will be provided by the study. The existing services delivered though government health systems will be continued. Government /NGO-led routine counseling and supplementary services available at Upazila and union levels, which include prenatal counseling, exclusive breastfeeding counseling, and maternal iron-folic acid supplementation and vitamin-A supplementation for children will continue. However, assessment of outcomes will be conducted in same frequency and schedule, alike in intervention arms, described in data collection section.
结局指标
主要结局
Change in Length-for-age Z scores (LAZ) at 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline LAZ at 7 days of birth.
时间窗: 1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age
Method of outcome assessment: Length measurement of study child
次要结局
- Nutritional intake (energy and protein) of pregnant women in intervention and comparison arms(~125 days of gestation till birth delivery)
- IYCF practices (age-appropriate complementary feeding along with continued breastfeeding until postnatal 2 years) among the intervention and comparison arms(6, 9, 12, 15, 18, 21 and 24 months of child's age)
- Change in weight-for-age Z scores (WAZ) at 1, 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline WAZ at 7 days of birth.(1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age)
- Early initiation of breastfeeding in intervention and comparison arms(Birth delivery)
- Maternal weight gain during pregnancy in intervention and comparison arms(~125 days of gestation till birth delivery)
- Birth weight of live newborns in intervention compared to comparison clusters(Birth delivery)
- Exclusive breastfeeding (EBF) rates up-to six months in intervention and comparison arms(Birth delivery to 6 months of child's age (180 days))
- Change in weight-for-length Z scores (WLZ) at 1, 3, 6, 12, 18 and 24 months age of children in intervention vs. comparison arms, compared to the baseline WLZ at 7 days of birth.(1, 3, 6, 9, 12, 15, 18, 21 and 24 months of child's age)