Improving Birth Outcomes in Bangladesh

NCT05855551 | Completed

• 1 other identifier: PHND-Jibon
• Study Type: interventional
• Target: 4,620
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal undernutrition is a global public health problem with far-reaching effects for both mothers and infants. Poor maternal nutrition negatively affects fetal growth and development. Both micro and macro-nutrients are required for the physiological changes and increased metabolic demands during pregnancy, including fetal growth and development. Women in Bangladesh have poor diets and are struggling to meet their nutrient requirements, especially during pregnancy and lactation when requirements are higher. Maternal undernutrition during pregnancy is associated with a range of adverse birth outcomes, including stillbirths, preterm births, low birthweight, and small-for-gestational-age (SGA) neonates, all of which remain unacceptably high in Bangladesh. Social protection provides a promising platform on which to leverage improvements in nutrition at scale, but current evidence on the impacts of social protection on birth outcomes is limited: few studies have been conducted and some of these studies suffer from methodological limitations. The planned study will contribute to filling this knowledge gap. An additional motivation for the study is provided by the recent WHO 2016 Antenatal Care Guidelines. The guidelines call for studies on the effectiveness of alternatives to providing energy and protein supplements to pregnant women (which is recommended in undernourished populations). Studying the effectiveness of providing combinations of food and cash will help build this evidence base. A third reason to conduct the study is that both food transfers and cash transfers are commonly used policy instruments in Bangladesh, and the choice of intervention components to scale up in the CBP will be guided by the findings from this pilot study. The study findings will thus be highly policy relevant. A three-arm cluster-randomized, non-masked, community-based, longitudinal trial will be used. Groups of pregnant women will be randomly assigned to one of three study arms providing different combinations of cash and food transfers.

Conditions

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

Outcome Measures

Primary Outcomes (19)

• 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 Outcomes (30)

• Gestational weekly weight gain up to the 2nd trimester

  Second pregnancy trimester

• Use of iron-folic acid, calcium, vitamin B complex, and multiple micronutrient supplements

  Second and third pregnancy trimester (34 ± 1 wk of pregnancy)

• Antenatal care utilization by the pregnant woman

  Second and third pregnancy trimester (34 ± 1 wk of pregnancy)

• Prenatal nutrition knowledge of the pregnant woman

  Second and third pregnancy trimester (34 ± 1 wk of pregnancy)

• Post natal care utilization by the mother of the newborn child

  Two months post-partum (61 d ± 1 wk)

Other Outcomes (2)

• Program enrollment

  Second and third pregnancy trimester (34 ± 1 wk of pregnancy), 2 months postpartum

• 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

Study Arms (3)

Arm 1 - base cash + BCC

EXPERIMENTAL

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; Behavioral: Behavior change communication (BCC)

Arm 2 - base cash + BCC + food

EXPERIMENTAL

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; Behavioral: Behavior change communication (BCC); Other: Food basket

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

EXPERIMENTAL

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; Behavioral: Behavior change communication (BCC); Other: Top-up cash

Interventions

Base cash transfer OTHER

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

Arm 1 - base cash + BCC; Arm 2 - base cash + BCC + food; Arm 3 - base cash + BCC + top-up cash

Behavior change communication (BCC) BEHAVIORAL

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

Arm 1 - base cash + BCC; Arm 2 - base cash + BCC + food; Arm 3 - base cash + BCC + top-up cash

Food basket OTHER

The monthly food basket will provide 10 kg micronutrient fortified rice , 3.5 kg of lentils, and 1000 ml of oil, valued at 800 BDT . Assuming a the ration is split equally among the 5 members of an average-sized household in rural Bangladesh and using food composition data for Bangladesh, the food basket is estimated to provide 354 kcal and 11 g of protein per person per day. The food basket will be provided once every month. The individually packaged foods will be distributed at the Union parishad office, community clinic, or another government facility in the first week of each month. The UDW will inform the beneficiaries of the place and time of the food distribution. Recipients will only receive the food when they present their food card. The card will also be used to record receipt of each ration. If beneficiaries cannot attend the food distribution themselves, a designated "nominee" can pick up the ration on their behalf.

Arm 2 - base cash + BCC + food

Top-up cash OTHER

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

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

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

rural areas in 6 upazilas in Bangladesh

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Birth Weight; Malnutrition; Gestational Weight Gain

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Weight Gain; Body Weight Changes

Study Officials

• Jef Leroy, PhD

  International Food Policy Research Institute

  PRINCIPAL INVESTIGATOR

• Shalini Roy, PhD

  International Food Policy Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: May 11, 2023
• Study Start: May 25, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

BA (1)