- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04868669
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Chandpur, Bangladesh
- International Centre for Diarrhoeal Disease Research, Bangladesh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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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No Intervention: Control
Pregnant women in this arm will receive standard antenatal care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
total gestational weight gain (kg)
Time Frame: pre-delivery
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pre-delivery
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rate of weight gain during the 2nd and 3rd trimester (kg/week)
Time Frame: pre-delivery
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pre-delivery
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proportion of women with inadequate total GWG according to IOM criteria
Time Frame: pre-delivery
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pre-delivery
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proportion of women with inadequate total GWG according to local criteria
Time Frame: 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
Time Frame: pre-delivery
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pre-delivery
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proportion of preterm births
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: at birth (delivery)
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at birth (delivery)
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proportion of women with pregnancy complications e.g. anemia, preeclampsia
Time Frame: 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
Time Frame: at delivery
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at delivery
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newborn Apgar score
Time Frame: at birth (delivery)
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at birth (delivery)
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proportion of infants developing morbidity
Time Frame: 4 weeks after birth
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4 weeks after birth
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proportion of infant mortality
Time Frame: 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"
Time Frame: 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"
Time Frame: 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"
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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.
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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
Time Frame: 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.
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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
Time Frame: at delivery
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at delivery
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Collaborators and Investigators
Investigators
- Principal Investigator: S. M. Tafsir Hasan, MBBS, MS, Nutrition and Clinical Services Division, icddr,b
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR-19109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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