Overview

This trial is active, not recruiting.

Conditions poor fetal growth, small-for-gestational age, premature birth
Treatment maternal nutrition behavior change
Phase phase 3
Sponsor International Food Policy Research Institute
Start date July 2015
End date August 2016
Trial size 3500 participants
Trial identifier NCT02745249, 2015-32-PHND-M

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
maternal nutrition behavior change
(No Intervention)
A&T-non intensive aim only receive MNCH services

Primary Outcomes

Measure
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
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
Dietary diversity during pregnancy
time frame: 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
Coverage of maternal nutrition intervention
time frame: 1 year

Secondary Outcomes

Measure
Early initiation of breastfeeding
time frame: 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

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

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
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?
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by International Food Policy Research Institute.