Balanced Energy and Protein (BEP) Supplementation Research in Bangladesh (JiVitA-BEP IR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,390
- 试验地点
- 1
- 主要终点
- Small-for-gestational age
研究概览
简要总结
The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low prepregnancy BMI or low prepregnancy BMI and inadequate gestational weight gain) on birth weight and adverse birth outcomes of low birth weight (LBW < 2500 g) and small-for-gestational age (SGA). To do this we are proposing a cluster-randomized, open labeled effectiveness trial with four arms The main question[s] it aims to answer are:
• Does mean birth weight and rate of LBW and SGA differ among mothers randomized to four arms that include targeted or untargeted BEP supplementation vs. MMS differ.
Participants will be recruited in early pregnancy and be enrolled in the trial and randomly receive:
- A daily BEP supplement from enrollment until birth
- A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement
- A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement or get switched to a BEP supplement based on inadequate gestational weight gain.
Researchers will compare the above groups to women receiving a MMS daily to see if birth weight is higher in the intervention arms. Other adverse outcomes such as low birth weight, small-for-gestational age and preterm birth will also be compared between groups and relative to the control.
详细描述
The primary aim of the study is to evaluate the effect of a fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low pre-pregnancy BMI or low pre-pregnancy BMI and inadequate gestational weight gain) on birth weight, low birth weight and SGA as the main outcomes. To do this we are proposing a cluster-randomized, open labeled effectiveness trial with four arms . Our main overall aim is:
- To compare the mean birth weight and rates of LBW and SGA among mother randomized across four arms including targeted and untargeted BEP versus MMS.
Additionally, to examine the effectiveness of untargeted and targeted BEP supplementation as follows: 2. To compare the mean birth weight, and rates of LBW and SGA among mothers who were randomized to receive BEP supplementation versus control (MMS) during pregnancy. [arm 2 versus 1] 3. To compare mean birth weight and rates of LBW and SGA among mothers who were randomized to receive BEP supplementation based on low pre-pregnancy BMI (w/wo inadequate gestational weight gain) versus control (MMS) during pregnancy. [arms 3+4 versus 1] 4. To compare mean birth weight and rates of LBW and SGA mothers who were randomized to receive BEP supplementation based on low pre-pregnancy BMI (w/wo inadequate gestational weight gain) versus BEP supplementation during pregnancy regardless of pre-pregnancy BMI. [arms 3+4 versus 2]
In addition to the above comparisons, between group differences and 95% confidence intervals will be estimated for both primary and secondary outcomes (shown below), with specific comparisons as described below for the primary outcome of birth weight.
Secondary Aims:
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
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Married women of reproductive age (15-35 y)
- •living in the selected study area who are pregnant and consent to participate in the study.
排除标准
- •Currently pregnant or lactating women (through 12 months postpartum),
- •Married women who are sterilized or widowed/divorced will not be included in the pregnancy surveillance being used to identify newly pregnant women.
- •Women with gestational age of >=28 weeks of gestation using reported last menstrual period.
研究组 & 干预措施
Arm 2
Balanced energy and protein (BEP) food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the World Health Organization (WHO) for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm all pregnant women will receive this intervention
干预措施: Balanced energy and protein supplement for pregnant women (Dietary Supplement)
Arm 3
Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (<18.5) will receive the BEP, the rest will receive the MMS.
干预措施: Balanced energy and protein supplement for pregnant women (Dietary Supplement)
Arm 4
Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (<18.5) and those who have inadequate gestational weight gain during pregnancy will receive the BEP, the rest will receive the MMS.
干预措施: Balanced energy and protein supplement for pregnant women (Dietary Supplement)
Arm 1
Multiple Micronutrient Supplement for Pregnant women (UNIMMAP formulation) containing 15 nutrients all at a recommended daily allowance (RDA) for pregnancy to be consumed one-per-day during pregnancy
干预措施: Multiple Micronutrient Supplement for pregnant women (Dietary Supplement)
结局指标
主要结局
Small-for-gestational age
时间窗: Measured within 0-72 hours of birth
Weight for a given gestational age lower than the 10th percentile of the reference standard
Birth weight
时间窗: Weight taken within 0-72 hours of birth
Birth weight
Low birth weight (weight < 2500 g) at birth
时间窗: Weight taken within 0-72 hours of birth
Dichotomous representation of the primary outcome
次要结局
- Chest circumference at birth(at birth)
- Birth length(Measured within 0-72 hours of birth)
- Gestational weight change(weight from pre-pregnancy to weight measured at birth)
- Proportion of inadequate gestational weight gain(From pre-pregnancy to birth)
- Head circumference at birth(at birth)
- Large for gestational age at birth(at birth)