Improving Maternal Nutrition in Matlab

NCT ID: NCT04868669

Last Updated: 2021-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2021-10-31

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.

Conditions

Gestational Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

In-home, intensive nutrition counseling

Intervention Type: BEHAVIORAL

• Individualized sessions will be conducted by trained health workers following a standard document (counseling booklet)
• The messages to be provided through the counseling will be contextualized
• Sessions will start from the early second trimester and repeat monthly until 36 weeks of gestation
• Counseling sessions will be conducted at the participant's place
• Sessions will involve influential family members such as the husband, mother-in-law, mother, and the household head along with the pregnant women
• Women will receive personalized feedback on their dietary intake pattern (dietary diversity) and the rate of weight gain in each session
• Sessions will be tailored according to each participant's need and progress

Control

Pregnant women in this arm will receive standard antenatal care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

In-home, intensive nutrition counseling

• Individualized sessions will be conducted by trained health workers following a standard document (counseling booklet)
• The messages to be provided through the counseling will be contextualized
• Sessions will start from the early second trimester and repeat monthly until 36 weeks of gestation
• Counseling sessions will be conducted at the participant's place
• Sessions will involve influential family members such as the husband, mother-in-law, mother, and the household head along with the pregnant women
• Women will receive personalized feedback on their dietary intake pattern (dietary diversity) and the rate of weight gain in each session
• Sessions will be tailored according to each participant's need and progress

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Obstetrical and Gynaecological Society of Bangladesh (OGSB)

UNKNOWN

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

S. M. Tafsir Hasan, MBBS, MS

Role: PRINCIPAL_INVESTIGATOR

Nutrition and Clinical Services Division, icddr,b

Locations

International Centre for Diarrhoeal Disease Research, Bangladesh

Chāndpur, , Bangladesh

Countries

Bangladesh

Other Identifiers

PR-19109

Identifier Type: -

Identifier Source: org_study_id