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

September 26, 2017 updated by: International Food Policy Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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?

Study Type

Interventional

Enrollment (Actual)

3500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, D.C., District of Columbia, United States, 20006
        • International Food Policy Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A&T- intensive
A&T-intensive arm receive standard MNCH services and intensified maternal nutrition behavior change intervention which focus on improving dietary practices, specifically improved diversity of foods and energy intakes of pregnant women, and improved intake of calcium and iron/folic acid (IFA) supplements.
Behavioral: Maternal Nutrition Behavior change
No Intervention: A&T-non intensive
A&T-non intensive aim only receive MNCH services

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of iron-folic acid supplements
Time Frame: IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
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
Use of calcium supplements
Time Frame: Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
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
Dietary diversity during pregnancy
Time Frame: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Number of food groups women consumed
Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
Dietary micronutrient intakes
Time Frame: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
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
Coverage of maternal nutrition intervention
Time Frame: 1 year
The proportion of pregnant and recently delivery women expose to and use of MNCH platform during the last 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early initiation of breastfeeding
Time Frame: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
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
Exclusive breastfeeding
Time Frame: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Food Policy Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 1, 2016

First Submitted That Met QC Criteria

April 15, 2016

First Posted (Estimate)

April 20, 2016

Study Record Updates

Last Update Posted (Actual)

September 27, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-32-PHND-M

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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