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Improving Birth Outcomes in Bangladesh

I

International Food Policy Research Institute

Status

Completed

Conditions

Birth Weight
Small for Gestational Age at Delivery
Gestational Weight Gain
Diet; Deficiency

Treatments

Other: Top-up cash
Other: Base cash transfer
Other: Food basket
Behavioral: Behavior change communication (BCC)

Study type

Interventional

Funder types

Other

Identifiers

NCT05855551
PHND-Jibon

Details and patient eligibility

About

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.

Enrollment

4,620 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4,620 participants in 3 patient groups

Arm 1 - base cash + BCC
Experimental group
Description:
pregnant women in this arm will receive the standard package (800 BDT each month), and in addition intensive group-based BCC on nutrition with a focus on how to improve their dietary intake during pregnancy
Treatment:
Behavioral: Behavior change communication (BCC)
Other: Base cash transfer
Arm 2 - base cash + BCC + food
Experimental group
Description:
pregnant women in this arm will receive the standard package (i.e., arm 1) and in addition a monthly food basket. The monthly food basket will provide 10 kg micronutrient fortified rice, 3.5 kg of lentils, and 1000 ml of oil, valued at 1000 BDT.
Treatment:
Other: Food basket
Behavioral: Behavior change communication (BCC)
Other: Base cash transfer
Arm 3 - base cash + BCC + top-up cash
Experimental group
Description:
pregnant women in this arm will receive the standard package (i.e., arm 1) and in addition a monthly top-up cash of 1000 BDT to be added to the "base" amount that is part of the standard program.
Treatment:
Behavioral: Behavior change communication (BCC)
Other: Top-up cash
Other: Base cash transfer

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Jef Leroy, PhD

Data sourced from clinicaltrials.gov

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