Clinical trial NCT02745249: Assessing the Feasibility of Integrating Maternal Nutrition Interventions Into an Existing MNCH Platform in Bangladesh
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Fetal Growth
Small-for-gestational Age
Premature Birth
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Use of iron-folic acid supplements
timeFrame: IFA tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
measure: Use of calcium supplements
timeFrame: Calcium tablets used during 9 months of last pregnancy among recently delivered women with children <6 months of age by June 2016
measure: Dietary diversity during pregnancy
timeFrame: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
measure: Dietary micronutrient intakes
timeFrame: Pregnant women in second and third trimester of pregnancy (4-9 months) by June- August 2016
measure: Coverage of maternal nutrition intervention
timeFrame: 1 year
Secondary outcomes:
measure: Early initiation of breastfeeding
timeFrame: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
measure: Exclusive breastfeeding
timeFrame: Infants up to 6 months in a cross-sectional endline survey scheduled for June- August 2016
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: International Food Policy Research Institute
state: District of Columbia
Study officials:
References:
citation: Nguyen PH, Martin-Prevel Y, Moursi M, Tran LM, Menon P, Ruel MT, Arimond M. Assessing Dietary Diversity in Pregnant Women: Relative Validity of the List-Based and Open Recall Methods. Curr Dev Nutr. 2019 Nov 18;4(1):nzz134. doi: 10.1093/cdn/nzz134. eCollection 2020 Jan.
citation: Frongillo EA, Nguyen PH, Sanghvi T, Mahmud Z, Aktar B, Alayon S, Menon P. Nutrition Interventions Integrated into an Existing Maternal, Neonatal, and Child Health Program Reduce Food Insecurity Among Recently Delivered and Pregnant Women in Bangladesh. J Nutr. 2019 Jan 1;149(1):159-166. doi: 10.1093/jn/nxy249.
citation: Nguyen PH, Frongillo EA, Sanghvi T, Wable G, Mahmud Z, Tran LM, Aktar B, Afsana K, Alayon S, Ruel MT, Menon P. Engagement of Husbands in a Maternal Nutrition Program Substantially Contributed to Greater Intake of Micronutrient Supplements and Dietary Diversity during Pregnancy: Results of a Cluster-Randomized Program Evaluation in Bangladesh. J Nutr. 2018 Aug 1;148(8):1352-1363. doi: 10.1093/jn/nxy090.
citation: Nguyen PH, Kim SS, Sanghvi T, Mahmud Z, Tran LM, Shabnam S, Aktar B, Haque R, Afsana K, Frongillo EA, Ruel MT, Menon P. Integrating Nutrition Interventions into an Existing Maternal, Neonatal, and Child Health Program Increased Maternal Dietary Diversity, Micronutrient Intake, and Exclusive Breastfeeding Practices in Bangladesh: Results of a Cluster-Randomized Program Evaluation. J Nutr. 2017 Dec;147(12):2326-2337. doi: 10.3945/jn.117.257303. Epub 2017 Oct 11.