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NCT Number: NCT02745249

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

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.

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Key information

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Maternal Nutrition Behavior change

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

International Food Policy Research Institute

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 20, 2016
Registry last updated
Sep 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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