Improving Maternal Nutrition in Matlab (IMNiM)
In-home, Intensive Nutrition Counseling to Improve Gestational Weight Gain in Rural Bangladesh: A Cluster-Randomized Controlled Trial
Background: Maternal undernutrition and inadequate gestational weight gain (GWG) are prevalent in rural communities of low- and middle-income countries (LMICs). In Matlab, Bangladesh, 54% of the women fail to gain adequate weight (>4 kg) in the third trimester. Risks associated with inadequate GWG include giving birth to a small-for-gestational age (SGA) infant, low birth weight (LBW) infant, preterm birth (PTB), etc. Few contemporary studies examined the efficacy of nutrition counseling on GWG improvement in LMICs.
Objectives: The primary objective of this study is to assess whether in-home, intensive nutrition counseling during pregnancy, compared to standard antenatal care, could improve GWG among pregnant women in rural Bangladesh.
Methods: This prospective, two-arm, parallel group, equal allocation, open-label, community-based, cluster-randomized controlled trial will be conducted in the icddr,b service area of Matlab, a rural subdistrict of Bangladesh. Clusters will be randomly allocated 1:1 to the intervention arm in which pregnant women will receive monthly in-home, intensive nutrition counseling or the control arm in which pregnant women will receive standard antenatal care as offered by icddr,b and Govt. facilities. Fixed Site Clinics (FSCs) located at the homes of the community health research workers (CHRWs) will act as clusters. Of the 33 FSCs serving rural areas in the icddr,b service area, 20 will be selected randomly and listed. These 20 clinics will then be randomly allocated 1:1 to either an intervention or control group using a computer-generated random allocation sequence. To fulfil the required sample size, each selected CHRW will enroll 16 consecutive pregnancies. Required sample size is 16 women per cluster i.e. 160 women per arm. Eligible participants will be enrolled upon obtaining their consent by 13 and 6/7 weeks of gestation (first trimester) and followed up to 6 weeks postpartum. Trained health workers will visit the homes of the women in the intervention arm once a month and provide nutrition counseling to the women and her influential family members such as mothers, mothers-in-law and husbands. Both intention-to-treat and per-protocol analyses will be performed.
Outcome measures/variables: Proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to the US Institute of Medicine (IOM) 2009 guidelines is the primary outcome variable.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Chandpur、孟加拉国
- International Centre for Diarrhoeal Disease Research, Bangladesh
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Pregnant women permanently residing in the icddr,b service area of Matlab fulfilling the following criteria:
Inclusion Criteria:
- aged 18-39 years
- in the first trimester of pregnancy (before 14 weeks of gestation)
- BMI 16-24.99 kg/m^2 measured on enrollment
- willing to participate in the study
Exclusion criteria
- multiple pregnancy (carrying two or more fetuses)
- threatened abortion, persistent pervaginal bleeding, or cervical incompetence
- history of three or more consecutive abortions
- history of gestational diabetes, macrosomia, gestational hypertension, preeclampsia/eclampsia in a prior pregnancy
- chronic diseases, such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, Crohn's disease, ulcerative colitis, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy or any other diseases which could impede compliance with the study protocol
- taking medications known to influence fetal growth, such as insulin, thyroid hormones, glucocorticoids
- known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder
- scored as moderate or worse on enrollment on any one of the subscales of the Depression, Anxiety and Stress Scales-21 (DASS-21)
- inability to read or write Bengali
- belonging to moderately or severely food insecure households as measured by the Household Food Insecurity Access Scale (HFIAS)
- having a plan to move or deliver outside the study area
- women practicing some form of vegetarianism
- women belonging to a household from which another woman is already enrolled in the study
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Intervention
In this arm, pregnant women, along with their influential family members such as mothers, mothers-in-law, and husbands, will receive monthly in-home, intensive nutrition counseling during the prenatal period.
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无干预：Control
Pregnant women in this arm will receive standard antenatal care.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines
大体时间：Pre-delivery
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Pregnancy trimesters are defined as follows: 1st trimester (0 weeks - 13+6 weeks), 2nd trimester (14 completed weeks - 27+6 weeks), and 3rd trimester (28 completed weeks - childbirth).
Rate of weight gain between two time points (trimesters) will be calculated by subtracting the weight measured at the first time point from the weight measured at the second time point and dividing the derived value by the difference in weeks between the two time points.
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Pre-delivery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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total gestational weight gain (kg)
大体时间：pre-delivery
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pre-delivery
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rate of weight gain during the 2nd and 3rd trimester (kg/week)
大体时间：pre-delivery
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pre-delivery
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proportion of women with inadequate total GWG according to IOM criteria
大体时间：pre-delivery
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pre-delivery
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proportion of women with inadequate total GWG according to local criteria
大体时间：pre-delivery
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pre-delivery
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proportion of women with inadequate third trimester weight gain according to local criteria
大体时间：pre-delivery
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pre-delivery
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proportion of preterm births
大体时间：at delivery
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childbirth before 37 completed weeks
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at delivery
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maternal mid-upper arm circumference (MUAC) (mm)
大体时间：baseline, 36 weeks of gestation, at delivery and 6 weeks post-partum
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baseline, 36 weeks of gestation, at delivery and 6 weeks post-partum
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maternal weight (kg)
大体时间：baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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maternal body mass index (BMI) (kg/m^2)
大体时间：baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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weight and height (at baseline) will be combined to report BMI
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baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
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infant weight (g)
大体时间：at birth (delivery) and after 4 weeks
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at birth (delivery) and after 4 weeks
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infant length (cm)
大体时间：at birth (delivery) and after 4 weeks
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at birth (delivery) and after 4 weeks
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infant head circumference (cm)
大体时间：at birth (delivery) and after 4 weeks
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at birth (delivery) and after 4 weeks
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proportion of low birth weight (< 2500 g) infants
大体时间：at birth (delivery)
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at birth (delivery)
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proportion of small for gestational age (<10th percentile) infants according to Intergrowth-21st standards
大体时间：at birth (delivery)
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at birth (delivery)
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proportion of women with pregnancy complications e.g. anemia, preeclampsia
大体时间：at delivery
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at delivery
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proportion of women with obstetric complications e.g. induction of labor, caesarean section
大体时间：at delivery
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at delivery
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newborn Apgar score
大体时间：at birth (delivery)
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at birth (delivery)
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proportion of infants developing morbidity
大体时间：4 weeks after birth
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4 weeks after birth
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proportion of infant mortality
大体时间：4 weeks after birth
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4 weeks after birth
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dietary diversity score according to the "Guidelines for Measuring Household and Individual Dietary Diversity"
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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score range: 0-9; higher scores indicate a better outcome
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baseline, 36 weeks of gestation and 6 weeks post-partum
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dietary diversity score according to the "Minimum Dietary Diversity for Women: A Guide to Measurement"
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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score range: 0-10; higher scores indicate a better outcome
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with inadequate dietary diversity accroding to the "Minimum Dietary Diversity for Women: A Guide to Measurement"
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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score range: 0-10; <5 indicates inadequate dietary diversity
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baseline, 36 weeks of gestation and 6 weeks post-partum
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energy consumption (kcal)
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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baseline, 36 weeks of gestation and 6 weeks post-partum
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protein consumption (g)
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with symptoms of depression as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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DASS-21 is a validated, widely used, standardized self-report scale with 7 items in each subscale category of Depression, Anxiety, and Stress symptoms.
Responses are scored on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much/most of the time), with higher scores indicating higher levels of depression, anxiety or stress.
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with symptoms of anxiety as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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DASS-21 is a validated, widely used, standardized self-report scale with 7 items in each subscale category of Depression, Anxiety, and Stress symptoms.
Responses are scored on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much/most of the time), with higher scores indicating higher levels of depression, anxiety or stress.
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baseline, 36 weeks of gestation and 6 weeks post-partum
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proportion of women with symptoms of stress as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
大体时间：baseline, 36 weeks of gestation and 6 weeks post-partum
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DASS-21 is a validated, widely used, standardized self-report scale with 7 items in each subscale category of Depression, Anxiety, and Stress symptoms.
Responses are scored on a 4-point Likert scale ranging from 0 (did not apply to me at all) to 3 (applied to me very much/most of the time), with higher scores indicating higher levels of depression, anxiety or stress.
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baseline, 36 weeks of gestation and 6 weeks post-partum
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healthcare seeking and services utilization e.g. number of prenatal visits
大体时间：at delivery
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at delivery
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合作者和调查者
调查人员
- 首席研究员：S. M. Tafsir Hasan, MBBS, MS、Nutrition and Clinical Services Division, icddr,b
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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