Joint Interventions to Improve Birth Outcomes and Nutrition in Bangladesh: the Jibon Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,620
- 试验地点
- 1
- 主要终点
- Mean probability of micronutrient adequacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- 未提供
结局指标
主要结局
Mean probability of micronutrient adequacy
时间窗: Second 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 trimester
时间窗: Third 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 birth
时间窗: Delivery
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)
时间窗: 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 child
时间窗: Second 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 attachment
时间窗: Two 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
Birthweight
时间窗: Within 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 trimester
时间窗: Third 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 gestation
时间窗: Delivery
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.
Prevalence of emotional violence towards the pregnant woman/mother of the newborn child
时间窗: Second 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)
Dietary protein intake
时间窗: Second 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 child
时间窗: Second 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 child
时间窗: Second 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 attachment
时间窗: Third 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 woman
时间窗: Second and third pregnancy trimester (34 ± 1 wk of pregnancy)
Measured using men's Perceived Stress Scale score (27).
Household food security
时间窗: Second 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 consumption
时间窗: Second 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 consumption
时间窗: Second 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 birthweight
时间窗: Within 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.
次要结局
- 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))
- 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))
- Mobility of the pregnant woman(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Social capital of the pregnant woman(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Husband's weight(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Colostrum intake, time between birth and putting infant to breast, (exclusive) breastfeeding after birth(Within 72 hours post partum)
- Neonatal and infant mortality(One and two months post-partum)
- Postpartum weight(Two months post-partum (61 d ± 1 wk))
- Decisionmaking by the pregnant woman/mother of the newborn child(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(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Institutional delivery(Within 72 hours post partum)
- Caesarian section(Within 72 hours post partum)
- Housing quality(Second pregnancy trimester; Two months post-partum (61 d ± 1 wk))
- Household asset ownership(Second pregnancy trimester; Two months post-partum (61 d ± 1 wk))
- Spousal relationship between the pregnant woman/mother of the newborn child and her husband(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Attitudes toward gender and intimate partner violence of the pregnant woman(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Birth length(Within 72 hours post partum)
- (Exclusive) breastfeeding and infant feeding practices at 2 months(Two months post-partum (61 d ± 1 wk))
- Labor force participation of the pregnant woman(Second and third pregnancy trimester (34 ± 1 wk of pregnancy))
- Skilled attendance at birth(Within 72 hours post partum)
- Household savings(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Agency of the pregnant woman(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Prenatal nutrition knowledge of the husband of the pregnant woman(Second and third pregnancy trimester (34 ± 1 wk of pregnancy))
- Infant length and weight(Two months post-partum (61 d ± 1 wk))
- Value of household non-food consumption(Second and third pregnancy trimester (34 ± 1 wk of pregnancy))
- Household loans(Second and third pregnancy trimester (34 ± 1 wk of pregnancy); Two months post-partum (61 d ± 1 wk))
- Household income from remittances(Third pregnancy trimester (34 ± 1 wk of pregnancy))