NCT04868669

Improving Maternal Nutrition in Matlab

In-home, Intensive Nutrition Counseling to Improve Gestational Weight Gain in Rural Bangladesh: A Cluster-Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-09-30
• Completion: 2021-10-31
• First posted: 2021-05-03
• Last updated: 2021-05-03

Locations

1 site across 1 country: Bangladesh