Peer Conselling Infant Feeding Education Program

NCT01333995 | Completed DMC

• 1 other identifier: PR-10001
• Study Type: interventional
• Target: 2,050
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infant Malnutrition; Pregnant Women; Lactating Mother; Breastfeeding; Infant Nutrition; Stunting

Keywords

Peer counselling; Infant; Intervention; breastfeeding; complementary feeding; stunting

Outcome Measures

Primary Outcomes (1)

• Reduction of stunting (HAZ)

  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).

  At 18 months

Secondary Outcomes (1)

• 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

  at 18 months

Study Arms (2)

Usual Health Message

NO INTERVENTION

No intervention mothers will recieve standard maternal and child care education

Peer counseling on infant feeding

SHAM COMPARATOR

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

Interventions

Peer counseling on infant feeding BEHAVIORAL

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.

Peer counseling on infant feeding

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• University of Sydney: collaborator

Study Sites (1)

Mirpur

Dhaka, 1216, Bangladesh

Location

Related Publications (1)

• Mihrshahi S, Ara G, Khanam M, Rasheed S, Agho KE, Kabir AI, Roy SK, Haider R, Derakhshani Hamadani J, Tofail F, Alam A, Dibley MJ. The Shishu Pushti Trial-Extended Peer Counseling for Improving Feeding Practices and Reducing Undernutrition in Children Aged 0-48 Months in Urban Bangladesh: Protocol for a Cluster-Randomized Controlled Trial. JMIR Res Protoc. 2022 Feb 7;11(2):e31475. doi: 10.2196/31475.

  PMID: 35129457 DERIVED

MeSH Terms

Conditions

Infant Nutrition Disorders; Breast Feeding; Growth Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Dibley

  University of Sydney

  PRINCIPAL INVESTIGATOR

• Sabrina Rasheed, Ph.D.

  The International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2010
• First Posted: April 12, 2011
• Study Start: June 1, 2010
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 12, 2015

Record last verified: 2010-02

Locations

BA (1)