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临床试验/NCT03040375
NCT03040375已完成不适用

Integrating Infant Feeding Counselling With Psychosocial Stimulation

International Centre for Diarrhoeal Disease Research, Bangladesh0 个研究点目标入组 365 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
365
主要终点
Changes in percentage of motor development among the children at 9 &12 months who received intervention

研究概览

简要总结

Undernutrition and poor cognitive development affect many children under 5 in developing countries, who are exposed to multiple risk factors including poverty, malnutrition, poor health, and unstimulating home environments. The optimum development and growth of young children requires affection and responsiveness from the mother/caregiver, cognitive stimulation, good nutrition and infection control. In Bangladesh, stimulation at home is generally poor and contributes to children's poorer development. It is important to show that psychosocial stimulation programmes through home visits integrated into the feeding programmes can benefit children's growth and development. This study will help to fill this evidence gap about effective interventions to improve infant and young child growth and development in Bangladesh. Considering the high prevalence of undernutrition and low prevalence of stimulating environments in Bangladesh, it is important to show evidence that integrating infant feeding counselling and psychosocial stimulation activities result in optimum child growth & development. To determine if combined infant feeding counselling and psychosocial stimulation programme (promoting mothers positive parenting) starting in the 3rd trimester of pregnancy, further improves: children's cognitive, motor and language development along with growth and mothers' child rearing and child-feeding knowledge and practices compared to peer counselling alone or usual health messages only. We used a community-based CRCT to examine the impact of a peer counselling infant feeding education program with psychosocial stimulation starting in the third trimester of pregnancy to one year after delivery, to improve child growth and cognition, language, behaviour and psychomotor development compared to a control group receiving usual health messages. The outcome assessments were made on a cohort of infant-mother dyads measured at baseline and at follow up visits. Outcome assessments were conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 334 mother-infant dyads (167 in each treatment group).The main outcomes are children's growth, cognition, language, behaviour and psychomotor development

详细描述

Study design It was a randomized controlled trial of integrating infant feeding counselling and psychosocial stimulation in slums of Mirpur, Dhaka. The trial was conducted in slum communities on the edge of Dhaka with 10 clusters of city blocks for each of the 2 study groups (167 mothers/infant pairs in each group). The two groups 1) Psychosocial stimulation + feeding counselling group and 2) Control group. The peer counselling education and psychosocial stimulation intervention will be delivered to the mothers, by locally recruited and trained peer counsellors, starting in the third trimester of pregnancy until the child is one year of age. The peer counselling education was offered to eligible pregnant women identified by household survey over 2 months in each community cluster in the intervention groups. Using a similar approach to recruitment, a cohort of mother-infant dyads, who received standard maternal and child health care programmes,were identified in the control clusters. Outcome assessments conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 334 mother-infant dyads. There was a baseline assessment of demographic information and further assessments of growth every 3 months from birth until the children are 12 months of age. The developmental assessments in children will be conducted at 12 months of age.

Sampling scheme A community based randomized controlled trial namely "Mirpur Shishu Pushti Trial" is ongoing in 36 clusters within 4 wards of Mirpur municipality. The average population of a "Ward" is 350,000 people. There are approximately five "Mahallas" per "Ward" with an average population of 70,000 people. The unit of randomization for this trial was city block clusters (CBC) with a population of about 6,000. A list of 36 CBC has already been prepared using established GIS methods to map and census the households. These CBC are being used in the ongoing community trial (Shishu Pusti trial). This ongoing study includes two arms; a peer-counselling (Infant and Young Child Feeding) arm and a control arm and the aims are to assess if the peer-counselling program improves children's growth through an improvement in child-feeding program. In this present study, two stage cluster sampling will be used, at the first stage 10 cluster will be randomly selected from 36 pre-defined clusters under this study area, on the second stage, 5 clusters will be randomly allocated for each of the treatment group. As the duration of the present study is only 18 months, utilization of the same study field along with GIS mapping and population census will allow us to minimize time as well as cost for the current study.

Trained field assistants identified women who were in their third trimester of pregnancy by systematic door-to-door surveys across the "clusters" over two months period. Pregnant women aged 16 to 49 years were included. Women who plan to migrate from the Mirpur area after delivery was excluded.

There will be two types of intervention: one providing breast-feeding and complementary feeding counselling and the other breast-feeding and complementary feeding counselling + psychosocial stimulation interventions. The proposed individual peer counselling education will be of sufficient intensity to alter infant and young child feeding practices and to improve the growth and development of the young children, hence prevent malnutrition and developmental delay. The interventions will be delivered to the women starting in last trimester of pregnancy and until their child is one year of age.

a. Description of intervention

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • women aged 16 to 49 at third trimester pregnancy
  • No medical record of chronic disease
  • who would stay next 1 year in the study area
  • Healthy neonate

排除标准

  • Women having reported chronic illness
  • Would not stay in the study area
  • extremely low birth weight neonate
  • neonate with congenital anomaly

结局指标

主要结局

Changes in percentage of motor development among the children at 9 &12 months who received intervention

时间窗: 9 and 12 months

Early Initiation of Breastfeeding rate

时间窗: from birth to every 2 months till 1 year

Differences in percentage of stunting, wasting and underweight among the children who received intervention

时间窗: from birth to every 2 months till 1 year

次要结局

  • Differences in percentage of children at 6 & 9 months who receive solid, semi-solid or soft foods.(6 to 12 months)
  • Differences in percentage of children consuming foods from >4 food groups(6 to 12 months)
  • Differences in the mean intake of food energy, protein, carbohydrate, fat and selected micronutrients from complementary feeds(6 to 12 months)

研究者

申办方类型
Other
责任方
Sponsor

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