Improving Birth Outcomes in Bangladesh

NCT ID: NCT05855551

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4620 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-25
• Study Completion Date: 2024-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1 - base cash + BCC

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

Group Type: EXPERIMENTAL

Base cash transfer

Intervention Type: OTHER

Program beneficiaries will receive a monthly transfer of 800 BDT. A government-to-person (G2P) payment system will be used, which will transfer cash on a monthly basis. Under this new system, beneficiaries will select one of the following payment channels based on convenience: mobile financial services or through a bank transfer (which women in remote areas could access through agent banking). Each month, women will receive a text message from the government informing her that the money has been credited to her account.

Behavior change communication (BCC)

Intervention Type: BEHAVIORAL

The BCC strategy has two different components:

• Monthly courtyard meetings: Courtyard sessions (12 to 15 women) will be organized at a place no more than 15 to 20 minutes walking distance from the beneficiary's home. Family members (husband, mother-in-law, …) are invited to join the meeting. Sessions are part of a continuous 4-session cycle. Each session will lasts 1.5 hours and will use different didactic methods. Topics include pregnancy nutrition and care, breastfeeding, importance of different micronutrients, and nutrition and care during lactation. The importance of a healthy diet during pregnancy is repeated in each session. Pregnant women receive a take-home poster that summarizes how to eat a healthy diet during pregnancy.
• Home visits: Visits will cover the content of any sessions missed by pregnant women and will reinforce the messages regarding maternal diet on the take-home poster.

Arm 2 - base cash + BCC + food

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.

Group Type: EXPERIMENTAL

Base cash transfer

Intervention Type: OTHER

Program beneficiaries will receive a monthly transfer of 800 BDT. A government-to-person (G2P) payment system will be used, which will transfer cash on a monthly basis. Under this new system, beneficiaries will select one of the following payment channels based on convenience: mobile financial services or through a bank transfer (which women in remote areas could access through agent banking). Each month, women will receive a text message from the government informing her that the money has been credited to her account.

Behavior change communication (BCC)

Intervention Type: BEHAVIORAL

The BCC strategy has two different components:

• Monthly courtyard meetings: Courtyard sessions (12 to 15 women) will be organized at a place no more than 15 to 20 minutes walking distance from the beneficiary's home. Family members (husband, mother-in-law, …) are invited to join the meeting. Sessions are part of a continuous 4-session cycle. Each session will lasts 1.5 hours and will use different didactic methods. Topics include pregnancy nutrition and care, breastfeeding, importance of different micronutrients, and nutrition and care during lactation. The importance of a healthy diet during pregnancy is repeated in each session. Pregnant women receive a take-home poster that summarizes how to eat a healthy diet during pregnancy.
• Home visits: Visits will cover the content of any sessions missed by pregnant women and will reinforce the messages regarding maternal diet on the take-home poster.

Food basket

Intervention Type: OTHER

The monthly food basket will provide 10 kg micronutrient fortified rice , 3.5 kg of lentils, and 1000 ml of oil, valued at 800 BDT . Assuming a the ration is split equally among the 5 members of an average-sized household in rural Bangladesh and using food composition data for Bangladesh, the food basket is estimated to provide 354 kcal and 11 g of protein per person per day. The food basket will be provided once every month.

The individually packaged foods will be distributed at the Union parishad office, community clinic, or another government facility in the first week of each month. The UDW will inform the beneficiaries of the place and time of the food distribution. Recipients will only receive the food when they present their food card. The card will also be used to record receipt of each ration. If beneficiaries cannot attend the food distribution themselves, a designated "nominee" can pick up the ration on their behalf.

Arm 3 - base cash + BCC + top-up cash

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.

Group Type: EXPERIMENTAL

Base cash transfer

Intervention Type: OTHER

Program beneficiaries will receive a monthly transfer of 800 BDT. A government-to-person (G2P) payment system will be used, which will transfer cash on a monthly basis. Under this new system, beneficiaries will select one of the following payment channels based on convenience: mobile financial services or through a bank transfer (which women in remote areas could access through agent banking). Each month, women will receive a text message from the government informing her that the money has been credited to her account.

Behavior change communication (BCC)

Intervention Type: BEHAVIORAL

The BCC strategy has two different components:

• Monthly courtyard meetings: Courtyard sessions (12 to 15 women) will be organized at a place no more than 15 to 20 minutes walking distance from the beneficiary's home. Family members (husband, mother-in-law, …) are invited to join the meeting. Sessions are part of a continuous 4-session cycle. Each session will lasts 1.5 hours and will use different didactic methods. Topics include pregnancy nutrition and care, breastfeeding, importance of different micronutrients, and nutrition and care during lactation. The importance of a healthy diet during pregnancy is repeated in each session. Pregnant women receive a take-home poster that summarizes how to eat a healthy diet during pregnancy.
• Home visits: Visits will cover the content of any sessions missed by pregnant women and will reinforce the messages regarding maternal diet on the take-home poster.

Top-up cash

Intervention Type: OTHER

The monthly top-up cash of 1,000 BDT will be added to the "base" amount that is part of the standard program. For the top-up cash transfer, a person-to-person payment system is used. WFP will contract with one popular mobile banking service (either bKash or Rockets) for the monthly top-up cash transfers. About two weeks after receiving the base cash transfer, women will receive the top-up cash through a mobile account (which can also be used to receive the base cash transfer). A text message will be sent to the beneficiary to inform her that the top-up transfer has been made into her account.

Interventions

Base cash transfer

Program beneficiaries will receive a monthly transfer of 800 BDT. A government-to-person (G2P) payment system will be used, which will transfer cash on a monthly basis. Under this new system, beneficiaries will select one of the following payment channels based on convenience: mobile financial services or through a bank transfer (which women in remote areas could access through agent banking). Each month, women will receive a text message from the government informing her that the money has been credited to her account.

Intervention Type: OTHER

Behavior change communication (BCC)

The BCC strategy has two different components:

• Monthly courtyard meetings: Courtyard sessions (12 to 15 women) will be organized at a place no more than 15 to 20 minutes walking distance from the beneficiary's home. Family members (husband, mother-in-law, …) are invited to join the meeting. Sessions are part of a continuous 4-session cycle. Each session will lasts 1.5 hours and will use different didactic methods. Topics include pregnancy nutrition and care, breastfeeding, importance of different micronutrients, and nutrition and care during lactation. The importance of a healthy diet during pregnancy is repeated in each session. Pregnant women receive a take-home poster that summarizes how to eat a healthy diet during pregnancy.
• Home visits: Visits will cover the content of any sessions missed by pregnant women and will reinforce the messages regarding maternal diet on the take-home poster.

Intervention Type: BEHAVIORAL

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 800 BDT . Assuming a the ration is split equally among the 5 members of an average-sized household in rural Bangladesh and using food composition data for Bangladesh, the food basket is estimated to provide 354 kcal and 11 g of protein per person per day. The food basket will be provided once every month.

The individually packaged foods will be distributed at the Union parishad office, community clinic, or another government facility in the first week of each month. The UDW will inform the beneficiaries of the place and time of the food distribution. Recipients will only receive the food when they present their food card. The card will also be used to record receipt of each ration. If beneficiaries cannot attend the food distribution themselves, a designated "nominee" can pick up the ration on their behalf.

Intervention Type: OTHER

Top-up cash

The monthly top-up cash of 1,000 BDT will be added to the "base" amount that is part of the standard program. For the top-up cash transfer, a person-to-person payment system is used. WFP will contract with one popular mobile banking service (either bKash or Rockets) for the monthly top-up cash transfers. About two weeks after receiving the base cash transfer, women will receive the top-up cash through a mobile account (which can also be used to receive the base cash transfer). A text message will be sent to the beneficiary to inform her that the top-up transfer has been made into her account.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bill and Melinda Gates Foundation

OTHER

Sponsor Role: collaborator

International Food Policy Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jef Leroy, PhD

Role: PRINCIPAL_INVESTIGATOR

International Food Policy Research Institute

Shalini Roy, PhD

Role: PRINCIPAL_INVESTIGATOR

International Food Policy Research Institute

Locations

rural areas in 6 upazilas in Bangladesh

Dhaka, , Bangladesh

Countries

Bangladesh

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

PHND-Jibon

Identifier Type: -

Identifier Source: org_study_id