Clinical trial NCT04868669: Improving Maternal Nutrition in Matlab
Official title: In-home, Intensive Nutrition Counseling to Improve Gestational Weight Gain in Rural Bangladesh: A Cluster-Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Weight Gain
Keywords: nutrition counseling
gestational weight gain
cluster randomized controlled trial
birth weight
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Obstetrical and Gynaecological Society of Bangladesh (OGSB)
First posted: 2021-05-03
Enrollment: 287
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, two-arm, parallel-group, equal allocation, open-label, community-based, cluster-randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines
timeFrame: Pre-delivery
Secondary outcomes:
measure: total gestational weight gain (kg)
timeFrame: pre-delivery
measure: rate of weight gain during the 2nd and 3rd trimester (kg/week)
timeFrame: pre-delivery
measure: proportion of women with inadequate total GWG according to IOM criteria
timeFrame: pre-delivery
measure: proportion of women with inadequate total GWG according to local criteria
timeFrame: pre-delivery
measure: proportion of women with inadequate third trimester weight gain according to local criteria
timeFrame: pre-delivery
measure: proportion of preterm births
timeFrame: at delivery
measure: maternal mid-upper arm circumference (MUAC) (mm)
timeFrame: baseline, 36 weeks of gestation, at delivery and 6 weeks post-partum
measure: maternal weight (kg)
timeFrame: baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
measure: maternal body mass index (BMI) (kg/m^2)
timeFrame: baseline, 36 weeks of gestation, pre-delivery, at delivery and 6 weeks post-partum
measure: infant weight (g)
timeFrame: at birth (delivery) and after 4 weeks
measure: infant length (cm)
timeFrame: at birth (delivery) and after 4 weeks
measure: infant head circumference (cm)
timeFrame: at birth (delivery) and after 4 weeks
measure: proportion of low birth weight (< 2500 g) infants
timeFrame: at birth (delivery)
measure: proportion of small for gestational age (<10th percentile) infants according to Intergrowth-21st standards
timeFrame: at birth (delivery)
measure: proportion of women with pregnancy complications e.g. anemia, preeclampsia
timeFrame: at delivery
measure: proportion of women with obstetric complications e.g. induction of labor, caesarean section
timeFrame: at delivery
measure: newborn Apgar score
timeFrame: at birth (delivery)
measure: proportion of infants developing morbidity
timeFrame: 4 weeks after birth
measure: proportion of infant mortality
timeFrame: 4 weeks after birth
measure: dietary diversity score according to the "Guidelines for Measuring Household and Individual Dietary Diversity"
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: dietary diversity score according to the "Minimum Dietary Diversity for Women: A Guide to Measurement"
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: proportion of women with inadequate dietary diversity accroding to the "Minimum Dietary Diversity for Women: A Guide to Measurement"
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: energy consumption (kcal)
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: protein consumption (g)
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: proportion of women with symptoms of depression as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: proportion of women with symptoms of anxiety as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: proportion of women with symptoms of stress as measured by Depression, Anxiety, and Stress Scales-21 (DASS-21) scales
timeFrame: baseline, 36 weeks of gestation and 6 weeks post-partum
measure: healthcare seeking and services utilization e.g. number of prenatal visits
timeFrame: at delivery
Other outcomes:
Locations:
city: Chandpur
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: Nutrition and Clinical Services Division, icddr,b
name: S. M. Tafsir Hasan, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
References: