Improving Maternal Nutrition in Matlab

NCT04868669 | Unknown DMC

• 1 other identifier: PR-19109
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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

Keywords

nutrition counseling; gestational weight gain; cluster randomized controlled trial; birth weight

Outcome Measures

Primary Outcomes (1)

• proportion of women with inadequate rate of weight gain in the second and third trimester of pregnancy according to IOM 2009 guidelines

  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.

  Pre-delivery

Secondary Outcomes (28)

• total gestational weight gain (kg)

  pre-delivery

• rate of weight gain during the 2nd and 3rd trimester (kg/week)

  pre-delivery

• proportion of women with inadequate total GWG according to IOM criteria

  pre-delivery

• proportion of women with inadequate total GWG according to local criteria

  pre-delivery

• proportion of women with inadequate third trimester weight gain according to local criteria

  pre-delivery

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: In-home, intensive nutrition counseling

Control

NO INTERVENTION

Pregnant women in this arm will receive standard antenatal care.

Interventions

In-home, intensive nutrition counseling 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

Intervention

Eligibility Criteria

• Age: 18 Years - 39 Years
• Gender Eligibility Details: This trial will focus on improving gestational weight gain in pregnant women. Hence, all the study participants are pregnant women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• Obstetrical and Gynaecological Society of Bangladesh (OGSB): collaborator

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Chāndpur, Bangladesh

Location

MeSH Terms

Conditions

Gestational Weight Gain; Birth Weight

Condition Hierarchy (Ancestors)

Weight Gain; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• S. M. Tafsir Hasan, MBBS, MS

  Nutrition and Clinical Services Division, icddr,b

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In this study, the blinding of the intervention is not feasible. However, the outcomes of the trial are objective in nature. Furthermore, the randomization and the statistical analysis will be carried out by someone unconnected to the allocation and enrollment process.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, two-arm, parallel-group, equal allocation, open-label, community-based, cluster-randomized controlled trial

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: May 3, 2021
• Study Start: January 15, 2020
• Primary Completion: September 30, 2021
• Study Completion: October 31, 2021
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)