Home-fortification Approaches for the Prevention of Malnutrition in Pregnant and Lactating Women and Their Children in Bangladesh: Program Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,011
- 试验地点
- 1
- 主要终点
- Birth weight
研究概览
简要总结
The program effectiveness study aims to assess the effect of a lipid-based nutrition supplement (LNS) and micronutrient powder (MNP) provided in a programmatic context for improving maternal nutritional status during pregnancy and lactation (LNS only), and preventing malnutrition in infants and young children (LNS and MNP) in Bangladesh.
详细描述
This study is a cluster-randomized controlled trial with four study "arms", implemented within the context of the Community Health and Development Program (CHDP) run by the World Mission Prayer League, which also has a hospital in the area and is known as LAMB. Data collection is longitudinal, starting with the identification of women in early pregnancy who are eligible to enter the study, and continuing, with follow-up of the child, until 24 months post-partum. A final follow-up visit will occur when the child is 36 months old to update contact information; no outcomes data will be collected at that final visit. The investigators are evaluating the effect of providing LNS-PLW to mothers during pregnancy and lactation on maternal health and nutrition outcomes (including anthropometric and micronutrient status), morbidity and birth outcomes in comparison to mothers who receive iron-folic acid tablets during pregnancy and lactation. The investigators are also evaluating the effect of three different home-fortification approaches (arms a-c, below) on child health and nutrition outcomes including anthropometric status, micronutrient status, anemia, and motor and cognitive development, in comparison to a control arm not receiving a home fortification intervention.
Additionally, the cost of implementation and delivery of the LNS-PLW, LNS-child or MNP interventions as part of the CHDP compared to standard CHDP program delivery will be documented. Willingness to pay (private demand) for LNS-PLW, LNS-child and MNP products by selected caregivers and male heads of households will be assessed at baseline and again at various points during the intervention period.
A process evaluation of the LNS and MNP interventions, and of the services provided to the control group, within the CHDP will be conducted to: 1) Document and evaluate the processes needed for implementation of interventions that provide a nutrient supplement such as LNS or MNP in the context of the CHDP; and 2) Explain and interpret program effectiveness study results and identify important facilitators and barriers to success of the nutrition intervention, which can be used to improve the effectiveness of current CHDP programs and future similar programs that include the scaling-up of LNS or MNP.
A post-intervention follow-up assessment for participants in the RDNS trial was added to the study protocol in November 2015. The intervention stopped when the study children turned 24 months old, and follow-up visits to update contact information were conducted when the children turned 36 months old. Thereafter, when the study children are between 40 and 52 months old, the follow-up assessment includes anthropometric and cognitive development assessments and collection of blood samples (finger prick, for measurement of hemoglobin) and buccal swab samples at the local clinics; for the mothers the follow-up includes anthropometric measurements, measurement of blood pressure and collection of fasting blood samples (finger prick). The follow-up also includes anthropometric measurements of the younger siblings, as well as a home visit to collect information on socioeconomic status, food security, hospitalizations of mother or child, developmental stimulation in the home, child food preferences and retrospective perceptions about the trial interventions.
Follow-up outcomes:
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
- Single (Investigator)
入排标准
- 年龄范围
- 6 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≤ 20 weeks
- •Planning to remain in the study area during pregnancy and the following three years (i.e., a permanent resident of the study area)
排除标准
- •Pregnancy identified and registered in the CHDP program before the beginning of the enrollment.
结局指标
主要结局
Birth weight
时间窗: Within 48 hours (or back calculated from later measurements).
Birth weight of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Child linear growth status at 24 months
时间窗: 24 months
Linear growth (the "comprehensive" LNS approach vs. the "child-only" LNS approach vs. "child-only" MNP) vis-à-vis one another and vis-à-vis the control group. Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
Birth length
时间窗: Within 48 hours (or back calculated from later measurements)
Birth length of the infants (women who received LNS-PLW vs. women who received iron-folic acid tablets). Pre-defined tests for interaction will be done for: baseline maternal characteristics (age, height, BMI, education, primiparity, food insecurity, wealth and gestational age at enrollment), time of year when outcome was assessed and child sex.
次要结局
- Duration of gestation(Day 0)
- Low birth weight(Within 48 hours (or back calculated from later measurements))
- Change in maternal weight between baseline and 36 wk gestation(Between 12-20 and 36 weeks of gestation)
- Pre-eclampsia(36 weeks of gestation)
- Pre-term delivery(Day 0)
- Newborn stunting(Within 48 hours (or back calculated from later measurements))
- Small for gestational age (SGA)(Within 48 hours (or back calculated from later measurements))
- Change in maternal iodine status between baseline and 6 mo postpartum(Between 10-20 weeks of gestation and 6 months postpartum)
- Change in maternal vitamin A status between baseline and 6 months postpartum(Between 10-20 weeks of gestation and 6 months postpartum)
- Change in maternal depressive symptoms between baseline and 6 months postpartum(Between 10-20 weeks of gestation and 6 months postpartum)
- Child hemoglobin concentration at 18 months of age(18 months)
- BMI z score at birth(Within 48 hours (or back calculated from later measurements))
- Small head size at birth(Within 48 hours (or back calculated from later measurements))
- Change in maternal weight between 42 d and 6 mo postpartum(Between 42 d and 6 mo postpartum)
- Wasting at 24 months of age(24 months)
- Head circumference at 24 months of age(24 months)
- Head circumference (HC) at birth(Within 48 hours (or back calculated from later measurements))
- Change in maternal iron status between baseline and 6 months postpartum(Between 10-20 weeks of gestation and 6 months postpartum)
- Child iron status at 18 months of age(18 months)
- Child iron-deficiency anemia status at 18 months of age(18 months)
- Stunting at 24 months of age(24 months)
- Change in maternal iron-deficiency anemia between baseline and 6 months postpartum(Between 10-20 weeks of gestation and 6 months postpartum)
- Child motor development at 24 months of age(24 months)
- Change in maternal anemia between baseline and 6 months postpartum(Between 10-20 weeks of gestation and 6 months postpartum)
- Child vitamin A status at 18 months of age(18 months)
- Child anemia status at 18 months of age(18 months)
- Child cognitive development at 24 months of age(24 months)