search
Back to results

BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR) (Target-BEP)

Primary Purpose

Fetal Growth Retardation, Low Birth Weight, Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Balanced energy and protein supplement for pregnant women
Multiple Micronutrient Supplement for pregnant women
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fetal Growth Retardation focused on measuring Pregnancy, Birth weight, Energy and protein, Micronutrients, Antenatal care, Nutrition, Birth outcomes

Eligibility Criteria

15 Years - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Married women of reproductive age (15-35 y)
  • living in the selected study area who are pregnant and consent to participate in the study.

Exclusion Criteria:

  • Currently pregnant or lactating women (through 12 months postpartum),
  • Married women who are sterilized or widowed/divorced will not be included in the pregnancy surveillance being used to identify newly pregnant women.
  • Women with gestational age of >=28 weeks of gestation using reported last menstrual period.

Sites / Locations

  • JiVitA ProjectRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Multiple Micronutrient Supplement for Pregnant women (UNIMMAP formulation) containing 15 nutrients all at a recommended daily allowance (RDA) for pregnancy to be consumed one-per-day during pregnancy

Balanced energy and protein (BEP) food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the World Health Organization (WHO) for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm all pregnant women will receive this intervention

Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (<18.5) will receive the BEP, the rest will receive the MMS.

Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (<18.5) and those who have inadequate gestational weight gain during pregnancy will receive the BEP, the rest will receive the MMS.

Outcomes

Primary Outcome Measures

Birth weight
Birth weight
Low birth weight (weight < 2500 g) at birth
Dichotomous representation of the primary outcome
Small-for-gestational age
Weight for a given gestational age lower than the 10th percentile of the reference standard

Secondary Outcome Measures

Birth length
Birth length
Gestational weight change
Gestational weight change during pregnancy
Proportion of inadequate gestational weight gain
Proportion of women with inadequate gestational weight gain
Head circumference at birth
Head circumference
Chest circumference at birth
chest circumference
Large for gestational age at birth
Weight for gestational age > 10th percentile using fetal growth standards

Full Information

First Posted
October 5, 2022
Last Updated
August 12, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, BRAC James P Grant School of Public Health, BRAC University
search

1. Study Identification

Unique Protocol Identification Number
NCT05576207
Brief Title
BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)
Acronym
Target-BEP
Official Title
Balanced Energy and Protein (BEP) Supplementation Research in Bangladesh (JiVitA-BEP IR)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
Bill and Melinda Gates Foundation, BRAC James P Grant School of Public Health, BRAC University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of the study is to evaluate the effect of fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low prepregnancy BMI or low prepregnancy BMI and inadequate gestational weight gain) on birth weight and adverse birth outcomes of low birth weight (LBW < 2500 g) and small-for-gestational age (SGA). To do this we are proposing a cluster-randomized, open labeled effectiveness trial with four arms The main question[s] it aims to answer are: • Does mean birth weight and rate of LBW and SGA differ among mothers randomized to four arms that include targeted or untargeted BEP supplementation vs. MMS differ. Participants will be recruited in early pregnancy and be enrolled in the trial and randomly receive: A daily BEP supplement from enrollment until birth A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement A daily BEP supplement from enrollment until birth, if they have low pre-pregnancy BMI with the rest receiving a MMS supplement or get switched to a BEP supplement based on inadequate gestational weight gain. Researchers will compare the above groups to women receiving a MMS daily to see if birth weight is higher in the intervention arms. Other adverse outcomes such as low birth weight, small-for-gestational age and preterm birth will also be compared between groups and relative to the control.
Detailed Description
The primary aim of the study is to evaluate the effect of a fortified balanced energy and protein (BEP) supplementation vs. control (multiple micronutrient supplement, MMS) without targeting and with targeting (either by low pre-pregnancy BMI or low pre-pregnancy BMI and inadequate gestational weight gain) on birth weight, low birth weight and SGA as the main outcomes. To do this we are proposing a cluster-randomized, open labeled effectiveness trial with four arms . Our main overall aim is: To compare the mean birth weight and rates of LBW and SGA among mother randomized across four arms including targeted and untargeted BEP versus MMS. Additionally, to examine the effectiveness of untargeted and targeted BEP supplementation as follows: To compare the mean birth weight, and rates of LBW and SGA among mothers who were randomized to receive BEP supplementation versus control (MMS) during pregnancy. [arm 2 versus 1] To compare mean birth weight and rates of LBW and SGA among mothers who were randomized to receive BEP supplementation based on low pre-pregnancy BMI (w/wo inadequate gestational weight gain) versus control (MMS) during pregnancy. [arms 3+4 versus 1] To compare mean birth weight and rates of LBW and SGA mothers who were randomized to receive BEP supplementation based on low pre-pregnancy BMI (w/wo inadequate gestational weight gain) versus BEP supplementation during pregnancy regardless of pre-pregnancy BMI. [arms 3+4 versus 2] In addition to the above comparisons, between group differences and 95% confidence intervals will be estimated for both primary and secondary outcomes (shown below), with specific comparisons as described below for the primary outcome of birth weight. Secondary Aims: To compare the mean birth weight and rates of LBW and SGA among mothers who received BEP supplementation during pregnancy based on low pre-pregnancy BMI versus untargeted BEP supplementation during pregnancy [arm 3 versus 2] To compare the mean birth weight and rates of LBW and SGA among mothers who received BEP supplementation during pregnancy versus BEP supplementation during pregnancy based on low pre-pregnancy BMI and gestational weight gain. [arm 4 versus 2] To compare the mean birth weight and rates of LBW and SGA among mothers who received BEP supplementation during pregnancy based on pre-pregnancy BMI only versus BEP supplementation during pregnancy based on low pre-pregnancy BMI and gestational weight gain. [arm 4 versus 3] To compare the difference in mean birth weights and rates of LBW and SGA among mothers who were randomized to receive BEP without targeting or with targeting relative to the control (MMS). [arm 2 versus 1 versus arm 3 and 4 versus 1] Other objectives of the study include: Assess how low mid upper arm circumference (MUAC) compares relative to low BMI in identifying women for targeting and how well MUAC change tracks with gestational weight gain change throughout pregnancy. Conduct a qualitative study in the three BEP arms of the study to better understand acceptability, use, sharing and other components of adherence to BEP among women and family members and understand women's perceptions related to the screening and targeting employed in the trial. Conduct a mixed methods implementation feasibility study to assess how feasible the most effective delivery approach of BEP (according to the trial findings) would be according to national and subnational stakeholders in Bangladesh. Conduct a costing and cost-effectiveness analysis to compare cost of screening and cost-effectiveness of targeted vs. an untargeted supplementation approach to inform future programs. The study design will be conducted as a cluster-randomized, unblinded trial with 4 arms among newly pregnant women. A total of 240 sectors (unit of randomization, comprising 150-200 households with women of reproductive age) will be randomized to one of the four supplementation arms, with control arm being provided a daily multiple micronutrient supplement (MMS). Arm 1: Control - Daily MMS Arm 2: All women receive BEP Arm 3: Low BMI women receive BEP, others receive MMS Arm 4: Low BMI women receive BEP, women with inadequate gestational weight gain get switched to BEP, other receive MMS Study Site and Participants: The study will be conducted in the re-sized "JiVitA" (a well established field site) study area in a rural northwestern district of Bangladesh. The BEP effectiveness trial will be done among married pregnant women of reproductive age. A home-based initial census will identify all women of reproductive age living in the selected JiVitA area. We will use the JiVitA pregnancy surveillance system entailing monthly ascertainment of last menstrual period and urine-based testing among women who missed their period in the past 30 days to identify newly pregnant women for enrollment in the study. During the surveillance weight and height of the women will be assessed to calculate pre-pregnancy body mass index (BMI). Randomization in the study will be done at a cluster level, with JIVitA sectors being used as the unit of randomization, as done in our previous studies. At pregnancy ascertainment, women will be consented for participation in the trial, and begin receiving their daily supplements as per their random allocation at the beginning of the second trimester. Field Procedures and Data Collection A cadre of JiVitA female staff (known as Community Health Research Workers (CHRWs), community health research workers) who are responsible for conducting the pregnancy surveillance will also be doing monthly anthropometry and distribution of the study interventions. Enrollment into the main trial will be conducted by experienced Field Interviewers (FIs), who will also be responsible for conducting a late pregnancy visit and birth assessment visits. Once a consenting pregnant woman has reached 12-14 weeks gestation, according to last menstrual period (LMP), her local CHRW will visit her monthly to distribute BEP and MMS supplements, collect compliance measurements for both, and to collect antenatal care (ANC) visit and provider history. Information collected from the women includes: household socioeconomic status and food security using the Food & Nutrition Technical Academy (FANTA) Household Food Insecurity Access Scale (HFAIS), pregnancy history, 7-day diet recall, 28-day morbidity recall, an empowerment and agency module based on the Women's Agency Scale, a depression module adapted from the Edinburgh Postnatal Depression Scale, and anthropometry, including weight, and MUAC. Hemoglobin levels will also be assessed using a finger-prick blood draw and Hemocue machine. A late pregnancy visit will also be conducted at about 32-34 week of gestation to collect diet, morbidity, anthropometry, depression and food security information as well as to repeat Hb. A birth surveillance system will be set up for birth notification and an early visit to the home for birth assessment and anthropometry. A female interviewer (FI) will conduct the visit to collect pregnancy outcome information, infant anthropometry (length, weight, head and chest circumference) and ask a brief questionnaire on labor and delivery and measure blood pressure. One month post livebirth or stillbirth a home visit will be done to assess infant vital status and to measure maternal weight to estimate BMI. Monitoring Supplement Adherence and Use In this effectiveness trial, supplement distribution will be done monthly. Empty food packets and MMS blister packs will be collected back and counted. A calendar to mark daily consumption will be given as an aid. After 2 weeks a phone based assessment of number of BEP packets or MMS tablets will be done as well counseling provided for any issues related to daily adherence and to encourage high compliance. Counseling: All women in the trial will receive counseling for antenatal care and danger signs using the behavior change communications materials developed by the Ministry of Health of Bangladesh. In addition, pamphlets for supplement benefits and use will be used for counseling. Adequate weight gain counseling using pamphlets will be done over the course of the pregnancy, across all four arms. Sample Size: Our sample size estimates are based on the hypothesis that either untargeted or targeted low pre-pregnancy BMI based BEP supplementation (along with MMS to women with normal BMI) will increase birth weight by 83 g and result in a relative risk reduction of 20% and 24% in SGA and LBW, respectively, compared with supplementation with MMS alone. We anticipate a total sample size of upto 2400 (600 *4 arms) live births and up to 3800 pregnant women identified through a pregnancy surveillance over 1.5 year of enrollment for the study. This is assuming a pregnancy loss of 30% and loss to follow-up of 6% and recruitment from 240 (or 60 per arm) sectors (units created in JiVitA and used for cluster randomization) across 6-8 Unions (sub-district administrative unit) of northwestern Bangladesh. Data Analysis Our primary treatment effects analysis will be done on singleton livebirths. The analysis will be an intention-to-treat approach, i.e. all study outcomes will be analyzed as randomized. We will present crude estimates of all primary and secondary outcomes with their 95% confidence intervals adjusted for clustering at the sector level using Huber-White sandwich estimators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Growth Retardation, Low Birth Weight, Preterm Birth, Gestational Weight Gain, Anemia of Pregnancy, Stunting, Pregnancy Complications
Keywords
Pregnancy, Birth weight, Energy and protein, Micronutrients, Antenatal care, Nutrition, Birth outcomes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Multiple Micronutrient Supplement for Pregnant women (UNIMMAP formulation) containing 15 nutrients all at a recommended daily allowance (RDA) for pregnancy to be consumed one-per-day during pregnancy
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Balanced energy and protein (BEP) food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the World Health Organization (WHO) for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm all pregnant women will receive this intervention
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (<18.5) will receive the BEP, the rest will receive the MMS.
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
Balanced energy and protein food supplement (ready-to-use) for pregnant women containing 15 nutrients all at an RDA for pregnancy, and Ca and P. to be consumed one-per-day during pregnancy. BEP is recommended by the WHO for pregnancy use in undernourished contexts. Bangladesh is one such place. In this arm, only low pre-pregnancy BMI women (<18.5) and those who have inadequate gestational weight gain during pregnancy will receive the BEP, the rest will receive the MMS.
Intervention Type
Dietary Supplement
Intervention Name(s)
Balanced energy and protein supplement for pregnant women
Other Intervention Name(s)
BEP
Intervention Description
A fortified balanced energy and protein supplement providing both macro and micronutrients recommended for use during pregnancy in undernourished contexts.
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple Micronutrient Supplement for pregnant women
Other Intervention Name(s)
MMS
Intervention Description
Prenatal supplements containing vitamins and minerals - also called "multiple micronutrient" supplements will be used in the control group.
Primary Outcome Measure Information:
Title
Birth weight
Description
Birth weight
Time Frame
Weight taken within 0-72 hours of birth
Title
Low birth weight (weight < 2500 g) at birth
Description
Dichotomous representation of the primary outcome
Time Frame
Weight taken within 0-72 hours of birth
Title
Small-for-gestational age
Description
Weight for a given gestational age lower than the 10th percentile of the reference standard
Time Frame
Measured within 0-72 hours of birth
Secondary Outcome Measure Information:
Title
Birth length
Description
Birth length
Time Frame
Measured within 0-72 hours of birth
Title
Gestational weight change
Description
Gestational weight change during pregnancy
Time Frame
weight from pre-pregnancy to weight measured at birth
Title
Proportion of inadequate gestational weight gain
Description
Proportion of women with inadequate gestational weight gain
Time Frame
From pre-pregnancy to birth
Title
Head circumference at birth
Description
Head circumference
Time Frame
at birth
Title
Chest circumference at birth
Description
chest circumference
Time Frame
at birth
Title
Large for gestational age at birth
Description
Weight for gestational age > 10th percentile using fetal growth standards
Time Frame
at birth
Other Pre-specified Outcome Measures:
Title
Length-for-age Z score at birth
Description
Length-for-age Z score (LAZ)
Time Frame
At Birth
Title
weight-for-length Z score at birth
Description
Weight-for-length (WLZ)
Time Frame
At Birth
Title
Stunting at birth
Description
LAZ < -2
Time Frame
At birth
Title
Wasting at birth
Description
WLZ < -2
Time Frame
At birth
Title
Short length for gestational age
Description
Length at birth < 10th percentile for gestational age at birth using fetal growth standards
Time Frame
At birth
Title
Postpartum BMI
Description
BMI at 1 month postpartum
Time Frame
1 month postpartum
Title
Maternal Hemoglobin
Description
Maternal Hemoglobin at the third trimester
Time Frame
At the third trimester (27-40 weeks)
Title
Maternal Anemia
Description
Maternal Anemia at the third trimester
Time Frame
At the third trimester (27-40 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Married women of reproductive age (15-35 y) living in the selected study area who are pregnant and consent to participate in the study. Exclusion Criteria: Currently pregnant or lactating women (through 12 months postpartum), Married women who are sterilized or widowed/divorced will not be included in the pregnancy surveillance being used to identify newly pregnant women. Women with gestational age of >=28 weeks of gestation using reported last menstrual period.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Towfida Siddiqua, PhD
Phone
880-1718722147
Email
towfida.jivita@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hasmot Ali, MBBS
Email
hasmot.jivita@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parul Christian, DrPH
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
JiVitA Project
City
Rangpur
Country
Bangladesh
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Towfida Siddiqua, PhD
Phone
880-1718-722147
Email
towfida.jivita@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual participant data (IPD) may be shared after 2-3 years of all primary /secondary publications have appeared to the funder and researchers who request pooled analysis requiring the type of data we collect, specifically investigators who are planning to conduct similar research and testing similar interventions as ours. Data will also be shared with the funder - the Bill & Melinda Gates foundation.

Learn more about this trial

BEP Supplementation Research in Bangladesh (JiVitA-BEP-IR)

We'll reach out to this number within 24 hrs