Peer Conselling Infant Feeding Education Program

This study is currently recruiting participants.
Verified February 2010 by International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT01333995
First received: December 7, 2010
Last updated: April 2, 2014
Last verified: February 2010
  Purpose

Child undernutrition remains a highly prevalent condition in low and middle income countries and a major portion of the global burden of childhood malnutrition is found in South Asia with an estimated 74 million children living with chronic malnutrition (stunted growth) in this region. This burden of malnutrition accounts for approximately 50% of under five child deaths in developing countries. The risk of child death is also related to the severity of malnutrition and progressively increases the more the child's growth deviates from WHO Growth Standard, e.g. children with height-for-age <-3 Z scores from the standard have a four fold increased mortality risk compared to children within one Z score of the growth standard mean. Underweight in children for 18.7% of the global disability-adjusted life years in children less than five years of age. Childhood malnutrition is a pervasive problem in Bangladesh with 43% of children less than five years stunted in 2004 and 38% in urban child populations. An establish approach to promoting appropriate breastfeeding practices is through the use of local peer counsellors to provide information and to support to mothers. A recent study has conducted on pioneering research on this approach in Bangladesh.. The main aim of the study is to use a Cluster Randomized Control Trial (CRCT) to collect high-level evidence of whether peer counselling of women to promote appropriate breastfeeding and complementary feeding can improve feeding practices, child growth and reduce the prevalence of malnutrition in their children.

The investigators will use a community-based Cluster Randomized Control Trial (CRCT) to examine the impact of a peer counselling infant feeding education program starting in the third trimester of pregnancy to one year after delivery, to improve child feeding practices, child growth and reduce the prevalence of malnutrition in their children. This will result in two study groups. The outcome assessments will be made on a cohort of infant-mother dyads measured at baseline and at follow up visits because the investigators expect a likely high correlation between baseline and follow up outcome measures, thus making this approach the most efficient study design. Outcome assessments will be conducted with all the mother-infant pairs recruited in the community clusters in the study, with an expected total of 1950 mother-infant days (975 in each treatment group). The peer counseling education will be offered to eligible pregnant women identified by household surveys over 3 months in each community cluster in the intervention group. Using a similar approach to recruitment, a cohort of mother-infant dyads, who will receive standard maternal and child health care programs, will be identified in the control clusters.

Data will be collected on anthropometry, feeding practices and hygiene and caring practices etc. The investigators will report the results for 2-sided 5% tests for the primary trial outcome. Secondary analyses will examine each outcome variable (stunting, height-for-age, feeding patterns, and mean nutrient intakes) taking account of the repeated measurements within children by using separate mixed models. The investigators will use linear mixed models for continuous outcomes (e.g. height-for-age Z) and generalized linear mixed models for non-continuous outcomes (e.g. logistic mixed models for binary outcomes e.g. percentage exclusively breastfeeding). It is expected that the publications from this research will have substantial impact on child health and will help with the development of public health nutrition policies for children in South Asia and will be widely cited.


Condition Intervention
Infant Malnutrition
Pregnant Women
Lactating Mother
Breastfeeding
Infant Nutrition
Stunting
Behavioral: Peer counseling on infant feeding

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Peer Counselling to Improve Feeding Practices and Reduce Malnutrition in Children 0-2 Years in Bangladesh

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Reduction of stunting (HAZ) [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    We expect children in the intervention group (mothers getting counselling on breastfeeding and complementary feeding) will attain a better linear growth compare to control group (not receiving counselling).


Secondary Outcome Measures:
  • The percentage of children consuming foods from >4 food groups at 9, 12, 15 and 18 months will be increased, in peer counselling group, compared with mothers without the intervention [ Time Frame: at 18 months ] [ Designated as safety issue: No ]

    Secondary objectives

    1. The percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 3 and 6 months will be increased, in the peer counselling group, compared with mothers without the intervention.
    2. The percentage of children consuming foods from >4 food groups at 9, 12, 15 and 18 months will be increased, in peer counselling group, compared with mothers without the intervention.


Estimated Enrollment: 1950
Study Start Date: June 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Health Message
No intervention mothers will recieve standard maternal and child care education
Sham Comparator: Peer counseling on infant feeding
Peer counseling intervention group will recieve nutrition education on initiation of breastfeeding within one hour of delivery, continuation of exclusive breastfeeding until six months, and timely introduction of safe, nutritionally adequate complementary feeding after six months.
Behavioral: Peer counseling on infant feeding
Peer counseling intervention group will recieve nutrition education on initiation of breastfeeding within one hour of delivery, continuation of exclusive breastfeeding until six months, and timely introduction of safe, nutritionally adequate complementary feeding after six months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women will be included who are 16 to 35 years with no more than three living children.

Exclusion Criteria:

  • Women who plan to migrate from the Mirpur area after delivery will be excluded.
  • Women with documented medical records of heart disease, tuberculosis, gestational diabetes or eclampsia in previous pregnancies will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01333995

Contacts
Contact: AKM Iqbal Kabir, Ph.D. 88028860523-32 ext 2312 ikabir@icddrb.org

Locations
Bangladesh
Mirpur Recruiting
Dhaka, Bangladesh, 1216
Contact: AKM Iqbal Kabir, Ph.D.    008802 8860523-32 ext 2312    ikabir@icddrb.org   
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of Sydney
Investigators
Principal Investigator: AKM Iqbal Kabir, Ph.D. International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided

Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT01333995     History of Changes
Other Study ID Numbers: PR-10001
Study First Received: December 7, 2010
Last Updated: April 2, 2014
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Peer counselling
Infant
Intervention
breastfeeding
complementary feeding
stunting

Additional relevant MeSH terms:
Malnutrition
Infant Nutrition Disorders
Child Nutrition Disorders
Nutrition Disorders

ClinicalTrials.gov processed this record on April 16, 2014