Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh

Premature Birth Clinical Trial

Official title:

Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing Maternal, Newborn, and Child Health Platform in Bangladesh: A Cluster-randomized Operational Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02745249
• Other study ID #: 2015-32-PHND-M
• Status: Completed
• Phase: N/A
• First received: April 1, 2016
• Last updated: September 26, 2017
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: September 2017
• Source: International Food Policy Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive & Thrive (A&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do. In Phase 2, Alive & Thrive decided to focus on integrating a package of maternal nutrition interventions in a large-scale maternal, newborn and child health program (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized evaluation design.

Description:

Inadequate maternal nutrition is likely to undermine the potential impact of IYCF improvements made in the Alive & Thrive (A&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do (WHO Healthy Growth project). In a study of 16,290 singleton infants born in rural Bangladesh from 2004 to 2007, more than 50% were born with low birth-weight. Low birth-weight is a risk factor for neonatal deaths, estimated to be 37 per 1,000 live births in Bangladesh. Factors associated with low birth-weight include young maternal age, poor pre-pregnant nutritional status, short birth intervals, poor maternal dietary intake (quality, quantity, and diversity), and inadequate pregnancy weight gain. Better maternal nutrition will improve maternal and newborn outcomes and facilitate achievement of a continuum of good nutrition.

In setting its country program goal for Bangladesh in phase 2, Alive & Thrive decided to focus on demonstrating the feasibility of integrating a package of maternal nutrition interventions in a large-scale MNCH program. Maternal nutrition should receive equal priority as child nutrition and the A&T program of BRAC already has developed an effective strategy though improving IYCF practices. MNCH programs offer the best opportunity for achieving large scale and sustainability. The GOB also promotes mainstreaming of nutrition intervention in health services. Considering the behavior change focus of the Alive & Thrive strategy, efforts will concentrate on improving dietary practices, specifically, improved diversity of foods and energy intakes of pregnant women, and improve the intake of calcium and iron/folic acid supplements. BRAC's supply system will be used to ensure access to calcium and iron/folic acid supplements. The current Government of Bangladesh guidelines of supplementing pregnant women with iron and folic acid and calcium, taken with food (to minimize adverse effects) would be a focus of behavior change interventions.

The primary objectives of the proposed evaluation are to answer the following questions using a cluster-randomized evaluation design:

• Can the coverage and utilization of key maternal nutrition interventions be improved equitably by integrating nutrition-focused BCC and community mobilization into BRAC's rural MNCH program?

• What factors affect high quality integration of nutrition interventions into a well-established MNCH program platform?

Secondary objectives are to examine the following question:

• Can an intensive, formative-research based BCC intervention for maternal nutrition improve the quality of diets of pregnant women in rural Bangladesh and facilitate better early breastfeeding practices than via routine MNCH services?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3500
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Recently delivered women with children <6 months of age

• Pregnant women in second and third trimester and her husbands

• Frontline health workers in the areas

Exclusion Criteria:

• Age <18

• Mental disorders that cannot understand and answer the questions

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Poor Fetal Growth
• Premature Birth
• Small-for-gestational Age

Intervention

Behavioral:
• Maternal Nutrition Behavior change

Locations

Country	Name	City	State
United States	International Food Policy Research Institute	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
International Food Policy Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of iron-folic acid supplements	Recall the total number of IFA tablets consumed throughout the last pregnancy	IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Primary	Use of calcium supplements	Recall the total number of calcium tablets consumed throughout the last pregnancy	Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
Primary	Dietary diversity during pregnancy	Number of food groups women consumed	Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Primary	Dietary micronutrient intakes	Quantity of micronutrient intakes using 24-hour recall complemented by food weighing.	Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Primary	Coverage of maternal nutrition intervention	The proportion of pregnant and recently delivery women expose to and use of MNCH platform during the last 1 year	1 year
Secondary	Early initiation of breastfeeding	The proportion of newborns aged less than 6 months who were breastfed within 1 hour of birth	Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
Secondary	Exclusive breastfeeding	The proportion of infants aged less than 6 months who were exclusively breastfed on the day preceding the interview.	Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016