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Improving Birth Outcomes in Bangladesh

Not Applicable
Completed
Conditions
Gestational Weight Gain
Diet; Deficiency
Small for Gestational Age at Delivery
Birth Weight
Interventions
Other: Base cash transfer
Behavioral: Behavior change communication (BCC)
Other: Food basket
Other: Top-up cash
Registration Number
NCT05855551
Lead Sponsor
International Food Policy Research Institute
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
4620
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)
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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm 1 - base cash + BCCBase cash transferpregnant 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 2 - base cash + BCC + foodBase cash transferpregnant 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 3 - base cash + BCC + top-up cashBase cash transferpregnant 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.
Arm 2 - base cash + BCC + foodFood basketpregnant 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 3 - base cash + BCC + top-up cashBehavior change communication (BCC)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.
Arm 1 - base cash + BCCBehavior change communication (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
Arm 2 - base cash + BCC + foodBehavior change communication (BCC)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 3 - base cash + BCC + top-up cashTop-up cashpregnant 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.
Primary Outcome Measures
NameTimeMethod
Mean probability of micronutrient adequacySecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

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).

Total gestational weight gain by the third trimesterThird pregnancy trimester (34 ± 1 wk of pregnancy)

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.

Preterm birthDelivery

Using the length of gestation, we will determine the proportion of children born before 37 weeks of gestation.

Dietary energy intake and proportion of women below 85% of the estimate energy requirement (EER)Second and third pregnancy trimester (34 ± 1 wk of pregnancy)

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.

Prevalence of controlling behaviors towards the pregnant woman/mother of the newborn childSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Prevalence of any controlling behaviors in the past 6 months measured using the WHO Violence Against Women instrument (26).

Maternal-infant attachmentTwo months post-partum (61 d ± 1 wk)

Maternal attachment to their infant will be assessed at 2 months (i.e., 61 days) postpartum using the Postpartum Bonding Questionnaire

Prevalence of emotional violence towards the pregnant woman/mother of the newborn childSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Prevalence of any emotional intimate partner violence in the past 6 months measured using the WHO Violence Against Women instrument (26)

BirthweightWithin 72 hours post partum

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.

Gestational weekly weight gain 2nd to 3rd trimesterThird pregnancy trimester (34 ± 1 wk of pregnancy)

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.

Length of gestationDelivery

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.

Dietary protein intakeSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

The 24-hour recall data will be used to assess women's protein intake.

Prevalence of physical violence towards the pregnant woman/mother of the newborn childSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

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 childSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Measured using women's Perceived Stress Scale score

Maternal-fetal attachmentThird pregnancy trimester (34 ± 1 wk of pregnancy)

Maternal attachment to their unborn child will be assessed during their 3rd trimester of pregnancy using the Prenatal Attachment Inventory

Stress of the husband of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

Measured using men's Perceived Stress Scale score (27).

Household food securitySecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

The Household Food Insecurity Access Scale will be used to measure household food security status.

Value of household food consumptionSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

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).

Value of total household consumptionSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

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).

Low birthweightWithin 72 hours post partum

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.

Secondary Outcome Measures
NameTimeMethod
Prenatal nutrition knowledge of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

Women's knowledge related to nutrition will be assessed using a set of questions developed for this study.

Gestational weekly weight gain up to the 2nd trimesterSecond pregnancy 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 supplementsSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

Women will be asked to report on their use of these supplements during pregnancy.

Antenatal care utilization by the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

Antenatal care utilization will be assessed with respect to current recommendations in Bangladesh and with respect to the new WHO guidelines

Mobility of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Measured using mobility modules adapted from pro-WEAI (34).

Social capital of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Measured using modules on women's social interactions and perceptions of neighborhood responses to intimate partner violence, developed for the survey.

Husband's weightSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Weight of the husband will be assessed.

Colostrum intake, time between birth and putting infant to breast, (exclusive) breastfeeding after birthWithin 72 hours post partum

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).

Neonatal and infant mortalityOne and two months post-partum

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.

Postpartum weightTwo months post-partum (61 d ± 1 wk)

We will measure women's weight at the 2-month postpartum visit.

Birth lengthWithin 72 hours post partum

The length of the newborn will be assessed at the time of the birthweight assessment.

Decisionmaking by the pregnant woman/mother of the newborn childSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Measured using women's decision-making modules adapted from pro-WEAI (34).

Prevalence of individual acts of intimate partner violence towards the pregnant woman/mother of the newborn childSecond 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 in the past 6 months measured using the WHO Violence Against Women instrument (26)

Institutional deliveryWithin 72 hours post partum

We will ask if the baby was delivered in a health facility

Caesarian sectionWithin 72 hours post partum

Women will be asked if a c-section was used to deliver the child

Housing qualitySecond pregnancy trimester; Two months post-partum (61 d ± 1 wk)

Quality of housing stock, measured using a module developed for the study context and collected through household enumerator observation during interviews.

Household asset ownershipSecond pregnancy trimester; Two months post-partum (61 d ± 1 wk)

Index of household asset ownership, measured using a module developed for the study context.

Post natal care utilization by the mother of the newborn childTwo months post-partum (61 d ± 1 wk)

Postnatal care utilization will be assessed

Spousal relationship between the pregnant woman/mother of the newborn child and her husbandSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Measured using women's spousal relationship modules developed for the survey.

Attitudes toward gender and intimate partner violence of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Measured using women's attitudes toward gender and intimate partner violence modules developed for the survey.

(Exclusive) breastfeeding and infant feeding practices at 2 monthsTwo months post-partum (61 d ± 1 wk)

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).

Labor force participation of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

Measured using women's labor modules developed for the survey.

Skilled attendance at birthWithin 72 hours post partum

Women will be asked if a skilled birth attended the birth of the child

Household savingsSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

A continuous measure on total household savings, calculated using reported savings of each household member 15 years of age or older.

Agency of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

Measured using women's responses on locus of control (35).

Prenatal nutrition knowledge of the husband of the pregnant womanSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

Using a similar approach as that use for pregnant women, husband's nutrition knowledge.

Infant length and weightTwo months post-partum (61 d ± 1 wk)

Length and weight at 2 mo postpartum

Value of household non-food consumptionSecond and third pregnancy trimester (34 ± 1 wk of pregnancy)

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.

Household loansSecond and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk)

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.

Household income from remittancesThird pregnancy trimester (34 ± 1 wk of pregnancy)

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

Trial Locations

Locations (1)

rural areas in 6 upazilas in Bangladesh

🇧🇩

Dhaka, Bangladesh

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