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Improving Birth Outcomes in Bangladesh

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Base cash transfer
Behavior change communication (BCC)
Food basket
Top-up cash
Sponsored by
International Food Policy Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Birth Weight

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • rural areas in 6 upazilas in Bangladesh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1 - base cash + BCC

Arm 2 - base cash + BCC + food

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

Arm 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

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.

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.

Outcomes

Primary Outcome Measures

Gestational weekly weight gain 2nd to 3rd trimester
Women's weekly weight gain will be calculated by differencing women's weight obtained in the second and third trimester and dividing by the number of weeks between both measurements.
Total gestational weight gain by the third trimester
Total weight gain will be calculated by calculating the difference between women's third trimester weight and the weight obtained at the time of the census.
Dietary energy intake and proportion of women below 85% of the estimate energy requirement (EER)
Dietary energy intake will be assessed using a 24-hour recall in the second and third trimester (18). EER will be calculated using each woman's basal metabolic rate (estimated from the woman's age, gender, and current weight), level of physical activity, and pregnancy trimester. Factors of 1.4 for low, 1.7 for moderate, and 2.0 for high physical activity will be used (19). Additional energy requirement for the second and third trimester of pregnancy (340-350 kcal/d and 452-500 kcal/d, respectively, depending on which reference will be used (20,21)) will be added to account for gestational weight gain and increases in basal metabolic rate.
Dietary protein intake
The 24-hour recall data will be used to assess women's protein intake.
Mean probability of micronutrient adequacy
the mean of the probabilities of adequacy for 11 key micronutrients (iron, calcium, zinc, vitamin A, thiamin, riboflavin, niacin, vitamin B-6, vitamin B-12, vitamin C, and folate) will be calculated using the 24h recall data. The estimated usual intake will be used to calculate the probability that the usual intake was above the EAR during pregnancy (25).
Length of gestation
The difference between the date of birth and the first day of the last menstrual period (assessed in the first survey) will be used to calculate length of gestation.
Preterm birth
Using the length of gestation, we will determine the proportion of children born before 37 weeks of gestation.
Prevalence of emotional violence towards the pregnant woman/mother of the newborn child
Prevalence of any emotional intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Prevalence of controlling behaviors towards the pregnant woman/mother of the newborn child
Prevalence of any controlling behaviors in the past 6 months measured using the WHO Violence Against Women instrument (26).
Prevalence of physical violence towards the pregnant woman/mother of the newborn child
Prevalence of any physical intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Stress of the pregnant woman/mother of the newborn child
Measured using women's Perceived Stress Scale score
Maternal-fetal attachment
Maternal attachment to their unborn child will be assessed during their 3rd trimester of pregnancy using the Prenatal Attachment Inventory
Maternal-infant attachment
Maternal attachment to their infant will be assessed at 2 months (i.e., 61 days) postpartum using the Postpartum Bonding Questionnaire
Stress of the husband of the pregnant woman
Measured using men's Perceived Stress Scale score (27).
Birthweight
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life.
Low birthweight
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life. Low birthweight will be defined as a weight below 2500g.
Household food security
The Household Food Insecurity Access Scale will be used to measure household food security status.
Value of total household consumption
Aggregate value of household food and non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).
Value of household food consumption
Value of household food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).

Secondary Outcome Measures

Gestational weekly weight gain up to the 2nd trimester
Women's weekly weight gain will be calculated by differencing women's weight obtained at the census (before pregnancy) and second trimester and dividing by gestational age in weeks.
Use of iron-folic acid, calcium, vitamin B complex, and multiple micronutrient supplements
Women will be asked to report on their use of these supplements during pregnancy.
Antenatal care utilization by the pregnant woman
Antenatal care utilization will be assessed with respect to current recommendations in Bangladesh and with respect to the new WHO guidelines
Prenatal nutrition knowledge of the pregnant woman
Women's knowledge related to nutrition will be assessed using a set of questions developed for this study.
Post natal care utilization by the mother of the newborn child
Postnatal care utilization will be assessed
Postpartum weight
We will measure women's weight at the 2-month postpartum visit.
Spousal relationship between the pregnant woman/mother of the newborn child and her husband
Measured using women's spousal relationship modules developed for the survey.
Decisionmaking by the pregnant woman/mother of the newborn child
Measured using women's decision-making modules adapted from pro-WEAI (34).
Mobility of the pregnant woman
Measured using mobility modules adapted from pro-WEAI (34).
Labor force participation of the pregnant woman
Measured using women's labor modules developed for the survey.
Attitudes toward gender and intimate partner violence of the pregnant woman
Measured using women's attitudes toward gender and intimate partner violence modules developed for the survey.
Social capital of the pregnant woman
Measured using modules on women's social interactions and perceptions of neighborhood responses to intimate partner violence, developed for the survey.
Agency of the pregnant woman
Measured using women's responses on locus of control (35).
Prevalence of individual acts of intimate partner violence towards the pregnant woman/mother of the newborn child
Prevalence of individual acts of intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Institutional delivery
We will ask if the baby was delivered in a health facility
Skilled attendance at birth
Women will be asked if a skilled birth attended the birth of the child
Caesarian section
Women will be asked if a c-section was used to deliver the child
Prenatal nutrition knowledge of the husband of the pregnant woman
Using a similar approach as that use for pregnant women, husband's nutrition knowledge.
Husband's weight
Weight of the husband will be assessed.
Birth length
The length of the newborn will be assessed at the time of the birthweight assessment.
Infant length and weight
Length and weight at 2 mo postpartum
Colostrum intake, time between birth and putting infant to breast, (exclusive) breastfeeding after birth
Women will be asked whether and how they breastfeed their newborn child. We will also assess if other liquids are provided to the child (36).
(Exclusive) breastfeeding and infant feeding practices at 2 months
women will be asked whether and how they breastfeed their newborn child. We will also assess if other liquids and solid foods are provided to the child (36).
Neonatal and infant mortality
neonatal (within the first 1 month after birth) and infant (within the first 2 months after birth) mortality will be assessed through parental recall at the 2-month postpartum visit.
Value of household non-food consumption
Value of household non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32). The third-trimester assessment will be used to assess impact.
Housing quality
Quality of housing stock, measured using a module developed for the study context and collected through household enumerator observation during interviews.
Household asset ownership
Index of household asset ownership, measured using a module developed for the study context.
Household income from remittances
Measured with a module on income (Taka) from remittances received from relatives outside and within the country. The third-trimester assessment will be used to assess impact
Household savings
A continuous measure on total household savings, calculated using reported savings of each household member 15 years of age or older.
Household loans
A continuous measure on household loans, calculated using reported amounts of loans taken and outstanding amounts owed for each household member 15 years of age or older.

Full Information

First Posted
February 16, 2020
Last Updated
May 3, 2023
Sponsor
International Food Policy Research Institute
Collaborators
Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05855551
Brief Title
Improving Birth Outcomes in Bangladesh
Official Title
Joint Interventions to Improve Birth Outcomes and Nutrition in Bangladesh: the Jibon Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2023 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Food Policy Research Institute
Collaborators
Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birth Weight, Small for Gestational Age at Delivery, Diet; Deficiency, Gestational Weight Gain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3858 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - base cash + BCC
Arm Type
Experimental
Arm 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
Arm Title
Arm 2 - base cash + BCC + food
Arm Type
Experimental
Arm 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.
Arm Title
Arm 3 - base cash + BCC + top-up cash
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Base cash transfer
Intervention Description
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
Behavioral
Intervention Name(s)
Behavior change communication (BCC)
Intervention Description
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
Other
Intervention Name(s)
Food basket
Intervention Description
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
Intervention Name(s)
Top-up cash
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational weekly weight gain 2nd to 3rd trimester
Description
Women's weekly weight gain will be calculated by differencing women's weight obtained in the second and third trimester and dividing by the number of weeks between both measurements.
Time Frame
Third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Total gestational weight gain by the third trimester
Description
Total weight gain will be calculated by calculating the difference between women's third trimester weight and the weight obtained at the time of the census.
Time Frame
Third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Dietary energy intake and proportion of women below 85% of the estimate energy requirement (EER)
Description
Dietary energy intake will be assessed using a 24-hour recall in the second and third trimester (18). EER will be calculated using each woman's basal metabolic rate (estimated from the woman's age, gender, and current weight), level of physical activity, and pregnancy trimester. Factors of 1.4 for low, 1.7 for moderate, and 2.0 for high physical activity will be used (19). Additional energy requirement for the second and third trimester of pregnancy (340-350 kcal/d and 452-500 kcal/d, respectively, depending on which reference will be used (20,21)) will be added to account for gestational weight gain and increases in basal metabolic rate.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Dietary protein intake
Description
The 24-hour recall data will be used to assess women's protein intake.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Mean probability of micronutrient adequacy
Description
the mean of the probabilities of adequacy for 11 key micronutrients (iron, calcium, zinc, vitamin A, thiamin, riboflavin, niacin, vitamin B-6, vitamin B-12, vitamin C, and folate) will be calculated using the 24h recall data. The estimated usual intake will be used to calculate the probability that the usual intake was above the EAR during pregnancy (25).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Length of gestation
Description
The difference between the date of birth and the first day of the last menstrual period (assessed in the first survey) will be used to calculate length of gestation.
Time Frame
Delivery
Title
Preterm birth
Description
Using the length of gestation, we will determine the proportion of children born before 37 weeks of gestation.
Time Frame
Delivery
Title
Prevalence of emotional violence towards the pregnant woman/mother of the newborn child
Description
Prevalence of any emotional intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Prevalence of controlling behaviors towards the pregnant woman/mother of the newborn child
Description
Prevalence of any controlling behaviors in the past 6 months measured using the WHO Violence Against Women instrument (26).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Prevalence of physical violence towards the pregnant woman/mother of the newborn child
Description
Prevalence of any physical intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Stress of the pregnant woman/mother of the newborn child
Description
Measured using women's Perceived Stress Scale score
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Maternal-fetal attachment
Description
Maternal attachment to their unborn child will be assessed during their 3rd trimester of pregnancy using the Prenatal Attachment Inventory
Time Frame
Third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Maternal-infant attachment
Description
Maternal attachment to their infant will be assessed at 2 months (i.e., 61 days) postpartum using the Postpartum Bonding Questionnaire
Time Frame
Two months post-partum (61 d ± 1 wk)
Title
Stress of the husband of the pregnant woman
Description
Measured using men's Perceived Stress Scale score (27).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Birthweight
Description
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life.
Time Frame
Within 72 hours post partum
Title
Low birthweight
Description
Birthweight will be assessed within 48 to 72 hours after delivery to avoid the influence of transitory neonatal weight loss that typically happens during the first days of life. Low birthweight will be defined as a weight below 2500g.
Time Frame
Within 72 hours post partum
Title
Household food security
Description
The Household Food Insecurity Access Scale will be used to measure household food security status.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Value of total household consumption
Description
Aggregate value of household food and non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Value of household food consumption
Description
Value of household food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Secondary Outcome Measure Information:
Title
Gestational weekly weight gain up to the 2nd trimester
Description
Women's weekly weight gain will be calculated by differencing women's weight obtained at the census (before pregnancy) and second trimester and dividing by gestational age in weeks.
Time Frame
Second pregnancy trimester
Title
Use of iron-folic acid, calcium, vitamin B complex, and multiple micronutrient supplements
Description
Women will be asked to report on their use of these supplements during pregnancy.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Antenatal care utilization by the pregnant woman
Description
Antenatal care utilization will be assessed with respect to current recommendations in Bangladesh and with respect to the new WHO guidelines
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Prenatal nutrition knowledge of the pregnant woman
Description
Women's knowledge related to nutrition will be assessed using a set of questions developed for this study.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Post natal care utilization by the mother of the newborn child
Description
Postnatal care utilization will be assessed
Time Frame
Two months post-partum (61 d ± 1 wk)
Title
Postpartum weight
Description
We will measure women's weight at the 2-month postpartum visit.
Time Frame
Two months post-partum (61 d ± 1 wk)
Title
Spousal relationship between the pregnant woman/mother of the newborn child and her husband
Description
Measured using women's spousal relationship modules developed for the survey.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Decisionmaking by the pregnant woman/mother of the newborn child
Description
Measured using women's decision-making modules adapted from pro-WEAI (34).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Mobility of the pregnant woman
Description
Measured using mobility modules adapted from pro-WEAI (34).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Labor force participation of the pregnant woman
Description
Measured using women's labor modules developed for the survey.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Attitudes toward gender and intimate partner violence of the pregnant woman
Description
Measured using women's attitudes toward gender and intimate partner violence modules developed for the survey.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Social capital of the pregnant woman
Description
Measured using modules on women's social interactions and perceptions of neighborhood responses to intimate partner violence, developed for the survey.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Agency of the pregnant woman
Description
Measured using women's responses on locus of control (35).
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Prevalence of individual acts of intimate partner violence towards the pregnant woman/mother of the newborn child
Description
Prevalence of individual acts of intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Institutional delivery
Description
We will ask if the baby was delivered in a health facility
Time Frame
Within 72 hours post partum
Title
Skilled attendance at birth
Description
Women will be asked if a skilled birth attended the birth of the child
Time Frame
Within 72 hours post partum
Title
Caesarian section
Description
Women will be asked if a c-section was used to deliver the child
Time Frame
Within 72 hours post partum
Title
Prenatal nutrition knowledge of the husband of the pregnant woman
Description
Using a similar approach as that use for pregnant women, husband's nutrition knowledge.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Husband's weight
Description
Weight of the husband will be assessed.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Birth length
Description
The length of the newborn will be assessed at the time of the birthweight assessment.
Time Frame
Within 72 hours post partum
Title
Infant length and weight
Description
Length and weight at 2 mo postpartum
Time Frame
Two months post-partum (61 d ± 1 wk)
Title
Colostrum intake, time between birth and putting infant to breast, (exclusive) breastfeeding after birth
Description
Women will be asked whether and how they breastfeed their newborn child. We will also assess if other liquids are provided to the child (36).
Time Frame
Within 72 hours post partum
Title
(Exclusive) breastfeeding and infant feeding practices at 2 months
Description
women will be asked whether and how they breastfeed their newborn child. We will also assess if other liquids and solid foods are provided to the child (36).
Time Frame
Two months post-partum (61 d ± 1 wk)
Title
Neonatal and infant mortality
Description
neonatal (within the first 1 month after birth) and infant (within the first 2 months after birth) mortality will be assessed through parental recall at the 2-month postpartum visit.
Time Frame
One and two months post-partum
Title
Value of household non-food consumption
Description
Value of household non-food consumption expenditures. This is a continuous measure calculated from household survey responses on consumption behavior, using the methodology and questionnaire modules described by Deaton and Zaidi (32). The third-trimester assessment will be used to assess impact.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Housing quality
Description
Quality of housing stock, measured using a module developed for the study context and collected through household enumerator observation during interviews.
Time Frame
Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
Title
Household asset ownership
Description
Index of household asset ownership, measured using a module developed for the study context.
Time Frame
Second pregnancy trimester; Two months post-partum (61 d ± 1 wk)
Title
Household income from remittances
Description
Measured with a module on income (Taka) from remittances received from relatives outside and within the country. The third-trimester assessment will be used to assess impact
Time Frame
Third pregnancy trimester (34 ± 1 wk of pregnancy)
Title
Household savings
Description
A continuous measure on total household savings, calculated using reported savings of each household member 15 years of age or older.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Title
Household loans
Description
A continuous measure on household loans, calculated using reported amounts of loans taken and outstanding amounts owed for each household member 15 years of age or older.
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)
Other Pre-specified Outcome Measures:
Title
Program enrollment
Description
enrollment in the MCBP program
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy), 2 months postpartum
Title
Receipt of program benefits (base cash, food, top-up cash) and participation in BCC sessions
Time Frame
Second and third pregnancy trimester (34 ± 1 wk of pregnancy), 2 months postpartum

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jef Leroy, PhD
Phone
2028625600
Email
j.leroy@cgiar.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jef Leroy, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shalini Roy, PhD
Organizational Affiliation
International Food Policy Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
rural areas in 6 upazilas in Bangladesh
City
Dhaka
Country
Bangladesh
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zahidul Hassan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon completion of primary data analyses

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Improving Birth Outcomes in Bangladesh

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