Cognitive Change Clinical Trial
Official title:
Integrating Infant Feeding Counselling With Psychosocial Stimulation
Verified date | November 2014 |
Source | International Centre for Diarrhoeal Disease Research, Bangladesh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 365 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Women having reported chronic illness - Would not stay in the study area - extremely low birth weight neonate - neonate with congenital anomaly |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
International Centre for Diarrhoeal Disease Research, Bangladesh | University of Sydney |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in percentage of motor development among the children at 9 &12 months who received intervention | 9 and 12 months | ||
Primary | Early Initiation of Breastfeeding rate | from birth to every 2 months till 1 year | ||
Primary | Differences in percentage of stunting, wasting and underweight among the children who received intervention | from birth to every 2 months till 1 year | ||
Secondary | Differences in percentage of children at 6 & 9 months who receive solid, semi-solid or soft foods. | 6 to 12 months | ||
Secondary | Differences in percentage of children consuming foods from >4 food groups | 6 to 12 months | ||
Secondary | Differences in the mean intake of food energy, protein, carbohydrate, fat and selected micronutrients from complementary feeds | 6 to 12 months |
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