Improving Birth Outcomes in Bangladesh

Study Overview
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Brief Summary
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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.

Official Title
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Joint Interventions to Improve Birth Outcomes and Nutrition in Bangladesh: the Jibon Trial

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

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


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - base cash + BCC<br>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 | Other: Base cash transfer<br>* 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.<br>Behavioral: Behavior change communication (BCC)<br>* 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.<br>|
| Experimental: Arm 2 - base cash + BCC + food<br>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. | Other: Base cash transfer<br>* 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.<br>Behavioral: Behavior change communication (BCC)<br>* 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.<br>Other: Food basket<br>* 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.<br>|
| Experimental: Arm 3 - base cash + BCC + top-up cash<br>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. | Other: Base cash transfer<br>* 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.<br>Behavioral: Behavior change communication (BCC)<br>* 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.<br>Other: Top-up cash<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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. | Third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| Dietary protein intake | The 24-hour recall data will be used to assess women's protein intake. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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. | Delivery | 
| Preterm birth | Using the length of gestation, we will determine the proportion of children born before 37 weeks of gestation. | Delivery | 
| 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) | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| 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). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| 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) | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Stress of the pregnant woman/mother of the newborn child | Measured using women's Perceived Stress Scale score | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Maternal-fetal attachment | Maternal attachment to their unborn child will be assessed during their 3rd trimester of pregnancy using the Prenatal Attachment Inventory | Third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| Maternal-infant attachment | Maternal attachment to their infant will be assessed at 2 months (i.e., 61 days) postpartum using the Postpartum Bonding Questionnaire | Two months post-partum (61 d ± 1 wk) | 
| Stress of the husband of the pregnant woman | Measured using men's Perceived Stress Scale score (27). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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. | Within 72 hours post partum | 
| 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. | Within 72 hours post partum | 
| Household food security | The Household Food Insecurity Access Scale will be used to measure household food security status. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Second pregnancy trimester | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of 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 | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| Post natal care utilization by the mother of the newborn child | Postnatal care utilization will be assessed | Two months post-partum (61 d ± 1 wk) | 
| Postpartum weight | We will measure women's weight at the 2-month postpartum visit. | Two months post-partum (61 d ± 1 wk) | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Decisionmaking by the pregnant woman/mother of the newborn child | Measured using women's decision-making modules adapted from pro-WEAI (34). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Mobility of the pregnant woman | Measured using mobility modules adapted from pro-WEAI (34). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Labor force participation of the pregnant woman | Measured using women's labor modules developed for the survey. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Agency of the pregnant woman | Measured using women's responses on locus of control (35). | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| 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) | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Institutional delivery | We will ask if the baby was delivered in a health facility | Within 72 hours post partum | 
| Skilled attendance at birth | Women will be asked if a skilled birth attended the birth of the child | Within 72 hours post partum | 
| Caesarian section | Women will be asked if a c-section was used to deliver the child | Within 72 hours post partum | 
| Prenatal nutrition knowledge of the husband of the pregnant woman | Using a similar approach as that use for pregnant women, husband's nutrition knowledge. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| Husband's weight | Weight of the husband will be assessed. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| Birth length | The length of the newborn will be assessed at the time of the birthweight assessment. | Within 72 hours post partum | 
| Infant length and weight | Length and weight at 2 mo postpartum | Two months post-partum (61 d ± 1 wk) | 
| 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). | Within 72 hours post partum | 
| (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). | Two months post-partum (61 d ± 1 wk) | 
| 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. | One and two months post-partum | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| Housing quality | Quality of housing stock, measured using a module developed for the study context and collected through household enumerator observation during interviews. | Second pregnancy trimester; Two months post-partum (61 d ± 1 wk) | 
| Household asset ownership | Index of household asset ownership, measured using a module developed for the study context. | Second pregnancy trimester; Two months post-partum (61 d ± 1 wk) | 
| 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 | Third pregnancy trimester (34 ± 1 wk of pregnancy) | 
| Household savings | A continuous measure on total household savings, calculated using reported savings of each household member 15 years of age or older. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) | 
| 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. | Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk) |