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Integrating Infant Feeding Counselling With Psychosocial Stimulation to Improve Child Growth and Development in Urban Slum of Bangladesh

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ClinicalTrials.gov Identifier: NCT03040375
Recruitment Status : Completed
First Posted : February 2, 2017
Last Update Posted : February 2, 2017
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Infant Malnutrition Cognitive Change Behavioral: Peer counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Integrating Infant Feeding Counselling With Psychosocial Stimulation
Study Start Date : November 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Peer counselling
There were two types of intervention: one providing breast-feeding and complementary feeding counselling + psychosocial stimulation interventions.
Behavioral: Peer counselling
No Intervention: Non peer counselling
Usual health messages



Primary Outcome Measures :
  1. Changes in percentage of motor development among the children at 9 &12 months who received intervention [ Time Frame: 9 and 12 months ]
  2. Early Initiation of Breastfeeding rate [ Time Frame: from birth to every 2 months till 1 year ]
  3. Differences in percentage of stunting, wasting and underweight among the children who received intervention [ Time Frame: from birth to every 2 months till 1 year ]

Secondary Outcome Measures :
  1. Differences in percentage of children at 6 & 9 months who receive solid, semi-solid or soft foods. [ Time Frame: 6 to 12 months ]
  2. Differences in percentage of children consuming foods from >4 food groups [ Time Frame: 6 to 12 months ]
  3. Differences in the mean intake of food energy, protein, carbohydrate, fat and selected micronutrients from complementary feeds [ Time Frame: 6 to 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03040375    
Other Study ID Numbers: PR-14091
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: February 2, 2017
Last Verified: November 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Malnutrition
Infant Nutrition Disorders
Nutrition Disorders