Peer Conselling Infant Feeding Education Program
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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 |
- 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).
- 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
- 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.
- 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: | May 2014 |
| Estimated Primary Completion Date: | May 2014 (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 |
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| Contact: AKM Iqbal Kabir, Ph.D. | 88028860523-32 ext 2312 | ikabir@icddrb.org |
| Bangladesh | |
| Mirpur | Recruiting |
| Dhaka, Bangladesh, 1216 | |
| Contact: AKM Iqbal Kabir, Ph.D. 008802 8860523-32 ext 2312 ikabir@icddrb.org | |
| 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: | October 16, 2012 |
| 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 June 18, 2013