Improving Birth Outcomes in Bangladesh

Gestational Weight Gain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855551
• Other study ID #: PHND-Jibon
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: International Food Policy Research Institute
• Contact: Jef Leroy, PhD
• Phone: 2028625600
• Email: j.leroy[@]cgiar.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3858
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.

Behavioral:
• 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.

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Bangladesh	rural areas in 6 upazilas in Bangladesh	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
International Food Policy Research Institute	Bill and Melinda Gates Foundation

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Program enrollment	enrollment in the MCBP program	Second and third pregnancy trimester (34 ± 1 wk of pregnancy), 2 months postpartum
Other	Receipt of program benefits (base cash, food, top-up cash) and participation in BCC sessions		Second and third pregnancy trimester (34 ± 1 wk of pregnancy), 2 months postpartum
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	Preterm birth	Using the length of gestation, we will determine the proportion of children born before 37 weeks of gestation.	Delivery
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Postpartum weight	We will measure women's weight at the 2-month postpartum visit.	Two months post-partum (61 d ± 1 wk)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Institutional delivery	We will ask if the baby was delivered in a health facility	Within 72 hours post partum
Secondary	Skilled attendance at birth	Women will be asked if a skilled birth attended the birth of the child	Within 72 hours post partum
Secondary	Caesarian section	Women will be asked if a c-section was used to deliver the child	Within 72 hours post partum
Secondary	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)
Secondary	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)
Secondary	Birth length	The length of the newborn will be assessed at the time of the birthweight assessment.	Within 72 hours post partum
Secondary	Infant length and weight	Length and weight at 2 mo postpartum	Two months post-partum (61 d ± 1 wk)
Secondary	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
Secondary	(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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)