NCT03040375

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
Last Updated

February 2, 2017

Status Verified

November 1, 2014

Enrollment Period

1.6 years

First QC Date

December 27, 2016

Last Update Submit

January 31, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

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

    9 and 12 months

  • Early Initiation of Breastfeeding rate

    from birth to every 2 months till 1 year

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

    from birth to every 2 months till 1 year

Secondary Outcomes (3)

  • 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

Study Arms (2)

Peer counselling

EXPERIMENTAL

There were two types of intervention: one providing breast-feeding and complementary feeding counselling + psychosocial stimulation interventions.

Behavioral: Peer counselling

Non peer counselling

NO INTERVENTION

Usual health messages

Interventions

Peer counselling

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ara G, Khanam M, Papri N, Nahar B, Kabir I, Sanin KI, Khan SS, Sarker MSA, Dibley MJ. Peer Counseling Promotes Appropriate Infant Feeding Practices and Improves Infant Growth and Development in an Urban Slum in Bangladesh: A Community-Based Cluster Randomized Controlled Trial. Curr Dev Nutr. 2019 Jun 18;3(7):nzz072. doi: 10.1093/cdn/nzz072. eCollection 2019 Jul.

MeSH Terms

Conditions

Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2016

First Posted

February 2, 2017

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

February 2, 2017

Record last verified: 2014-11

Data Sharing

IPD Sharing
Will not share