Improving Maternal Nutrition in Matlab
- Conditions
- Gestational Weight Gain
- Interventions
- Behavioral: In-home, intensive nutrition counseling
- Registration Number
- NCT04868669
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 287
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention In-home, intensive nutrition counseling 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.
- Primary Outcome Measures
Name Time Method proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines 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.
- Secondary Outcome Measures
Name Time Method 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 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.
proportion of women with inadequate total GWG according to IOM criteria pre-delivery infant length (cm) at birth (delivery) and after 4 weeks newborn Apgar score at birth (delivery) 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 weight and height (at baseline) will be combined to report BMI
proportion of preterm births at delivery childbirth before 37 completed weeks
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 score range: 0-9; higher scores indicate a better outcome
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 score range: 0-10; \<5 indicates inadequate dietary diversity
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 score range: 0-10; higher scores indicate a better outcome
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 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.
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 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.
Trial Locations
- Locations (1)
International Centre for Diarrhoeal Disease Research, Bangladesh
🇧🇩Chandpur, Bangladesh