In-home, Intensive Nutrition Counseling to Improve Gestational Weight Gain in Rural Bangladesh: A Cluster-Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
In this study, the blinding of the intervention is not feasible. However, the outcomes of the trial are objective in nature. Furthermore, the randomization and the statistical analysis will be carried out by someone unconnected to the allocation and enrollment process.
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines
时间窗: Pre-delivery
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.
次要结局
- rate of weight gain during the 2nd and 3rd trimester (kg/week)(pre-delivery)
- proportion of women with inadequate total GWG according to local criteria(pre-delivery)
- total gestational weight gain (kg)(pre-delivery)
- maternal mid-upper arm circumference (MUAC) (mm)(baseline, 36 weeks of gestation, at delivery and 6 weeks post-partum)
- proportion of infants developing morbidity(4 weeks after birth)
- proportion of women with symptoms of stress as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales(baseline, 36 weeks of gestation and 6 weeks post-partum)
- newborn Apgar score(at birth (delivery))
- proportion of women with inadequate total GWG according to IOM criteria(pre-delivery)
- infant length (cm)(at birth (delivery) and after 4 weeks)
- proportion of women with inadequate third trimester weight gain according to local criteria(pre-delivery)
- maternal weight (kg)(baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum)
- maternal body mass index (BMI) (kg/m^2)(baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum)
- proportion of preterm births(at delivery)
- infant weight (g)(at birth (delivery) and after 4 weeks)
- proportion of low birth weight (< 2500 g) infants(at birth (delivery))
- proportion of small for gestational age (<10th percentile) infants according to Intergrowth-21st standards(at birth (delivery))
- energy consumption (kcal)(baseline, 36 weeks of gestation and 6 weeks post-partum)
- protein consumption (g)(baseline, 36 weeks of gestation and 6 weeks post-partum)
- infant head circumference (cm)(at birth (delivery) and after 4 weeks)
- dietary diversity score according to the "Guidelines for Measuring Household and Individual Dietary Diversity"(baseline, 36 weeks of gestation and 6 weeks post-partum)
- proportion of women with inadequate dietary diversity accroding to the "Minimum Dietary Diversity for Women: A Guide to Measurement"(baseline, 36 weeks of gestation and 6 weeks post-partum)
- proportion of women with pregnancy complications e.g. anemia, preeclampsia(at delivery)
- proportion of women with obstetric complications e.g. induction of labor, caesarean section(at delivery)
- proportion of infant mortality(4 weeks after birth)
- dietary diversity score according to the "Minimum Dietary Diversity for Women: A Guide to Measurement"(baseline, 36 weeks of gestation and 6 weeks post-partum)
- proportion of women with symptoms of anxiety as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales(baseline, 36 weeks of gestation and 6 weeks post-partum)
- healthcare seeking and services utilization e.g. number of prenatal visits(at delivery)
- proportion of women with symptoms of depression as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales(baseline, 36 weeks of gestation and 6 weeks post-partum)