Clinical trial NCT05855551: Improving Birth Outcomes in Bangladesh
Official title: Joint Interventions to Improve Birth Outcomes and Nutrition in Bangladesh: the Jibon Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Weight
Small for Gestational Age at Delivery
Diet; Deficiency
Gestational Weight Gain
Lead sponsor: International Food Policy Research Institute
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
First posted: 2023-05-11
Enrollment: 4620
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh.

Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant.

A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.


Eligibility criteria: Inclusion Criteria:

* Pregnant with their first or second child (in case of death of the first or second child during pregnancy or within two years of birth, the mother will be eligible during her third pregnancy);
* In possession of a valid NID (or a NID application acknowledgement).
* Meeting the eligibility criteria of the Government of Bangladesh' Mother and Child Benefit Programme (MCBP)

Primary outcomes:
measure: Gestational weekly weight gain 2nd to 3rd trimester
timeFrame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Total gestational weight gain by the third trimester
timeFrame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Dietary energy intake and proportion of women below 85% of the estimate energy requirement (EER)
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Dietary protein intake
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Mean probability of micronutrient adequacy
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Length of gestation
timeFrame: Delivery
measure: Preterm birth
timeFrame: Delivery
measure: Prevalence of emotional violence towards the pregnant woman/mother of the newborn child
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Prevalence of controlling behaviors towards the pregnant woman/mother of the newborn child
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Prevalence of physical violence towards the pregnant woman/mother of the newborn child
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Stress of the pregnant woman/mother of the newborn child
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Maternal-fetal attachment
timeFrame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Maternal-infant attachment
timeFrame: Two months post-partum (61 d ± 1 wk)
measure: Stress of the husband of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Birthweight
timeFrame: Within 72 hours post partum
measure: Low birthweight
timeFrame: Within 72 hours post partum
measure: Household food security
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Value of total household consumption
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Value of household food consumption
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Secondary outcomes:
measure: Gestational weekly weight gain up to the 2nd trimester
timeFrame: Second pregnancy trimester
measure: Use of iron-folic acid, calcium, vitamin B complex, and multiple micronutrient supplements
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Antenatal care utilization by the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Prenatal nutrition knowledge of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Post natal care utilization by the mother of the newborn child
timeFrame: Two months post-partum (61 d ± 1 wk)
measure: Postpartum weight
timeFrame: Two months post-partum (61 d ± 1 wk)
measure: Spousal relationship between the pregnant woman/mother of the newborn child and her husband
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Decisionmaking by the pregnant woman/mother of the newborn child
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Mobility of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Labor force participation of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Attitudes toward gender and intimate partner violence of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Social capital of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Agency of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Prevalence of individual acts of intimate partner violence towards the pregnant woman/mother of the newborn child
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Institutional delivery
timeFrame: Within 72 hours post partum
measure: Skilled attendance at birth
timeFrame: Within 72 hours post partum
measure: Caesarian section
timeFrame: Within 72 hours post partum
measure: Prenatal nutrition knowledge of the husband of the pregnant woman
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Husband's weight
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Birth length
timeFrame: Within 72 hours post partum
measure: Infant length and weight
timeFrame: Two months post-partum (61 d ± 1 wk)
measure: Colostrum intake, time between birth and putting infant to breast, (exclusive) breastfeeding after birth
timeFrame: Within 72 hours post partum
measure: (Exclusive) breastfeeding and infant feeding practices at 2 months
timeFrame: Two months post-partum (61 d ± 1 wk)
measure: Neonatal and infant mortality
timeFrame: One and two months post-partum
measure: Value of household non-food consumption
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Housing quality
timeFrame: Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
measure: Household asset ownership
timeFrame: Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
measure: Household income from remittances
timeFrame: Third pregnancy trimester (34 ± 1 wk of pregnancy)
measure: Household savings
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
measure: Household loans
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Other outcomes:
measure: Program enrollment
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy), 2 months postpartum
measure: Receipt of program benefits (base cash, food, top-up cash) and participation in BCC sessions
timeFrame: Second and third pregnancy trimester (34 ± 1 wk of pregnancy), 2 months postpartum
Locations:
city: Dhaka
country: Bangladesh
facility: rural areas in 6 upazilas in Bangladesh
Study officials:
affiliation: International Food Policy Research Institute
name: Jef Leroy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Food Policy Research Institute
name: Shalini Roy, PhD
role: PRINCIPAL_INVESTIGATOR
References: