Clinical trial NCT05108454: Multiple Micronutrient Supplementation (MMS) Evaluation Among Bangladeshi Pregnant Women
Official title: Evaluation of a Business Model of Multiple Micronutrient Supplementations (MMS) Project for Bangladeshi Pregnant Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infant, Low Birth Weight
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Children's Investment Fund Foundation
First posted: 2021-11-05
Enrollment: 4500
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 49
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant mothers live in either intervention or control areas in any trimester of pregnancy.

Brief summary: Maternal nutrition profoundly affects foetal growth, development, and subsequent infant birth weight. Babies with low birth weight (LBW) have an elevated risk of death in infancy and later childhood. A recent systematic review revealed that multiple micronutrient supplementations (MMS) could reduce the risk of LBW by 13% in comparison with iron and folic acid (IFA). Based on this newer evidence, the World Health Organization (WHO) recommended MMS during a pregnancy instead of IFA, with consideration of the country context-specific research. However, little progress is being achieved in ensuring adequate MMS coverage to improve pregnancy outcomes. Based on the WHO recommendation, CIFF awarded the Social Marketing Company (SMC) to set up a sustainable business model with affordable and quality MMS to pregnant women in Bangladesh over a period of 5 years through SMC's pharmacy networks. The investigators propose to develop an evaluation design including both process and outcome evaluation to evaluate the implementation and effect of the MMS by the SMC in Bangladesh. The evaluation study will comprise both process and outcome evaluation, complementing each other. The design will be a quasi-experimental cluster-based open cohort, two-arm, mixed-methods design. The evaluation would take place in 5 divisions of Bangladesh.

Detailed description: Background: a. Burden: Maternal nutrition profoundly affects foetal growth, development, and subsequent infant birth weight. Babies with low birth weight (LBW) have an elevated risk of death in infancy. Furthermore, these babies have a higher risk of stunting or linear growth failure and slower mental development in childhood. b. Knowledge gap: A recent systematic review revealed that multiple micronutrient supplementations (MMS) could reduce the risk of LBW by 13% in comparison with iron and folic acid (IFA). Based on this newer evidence, the World Health Organization (WHO) has updated the antenatal nutrition recommendations. Now, MMS is recommended during a pregnancy instead of IFA, with consideration of the country context-specific research. However, little progress is being achieved in ensuring adequate MMS coverage to improve pregnancy outcomes. Furthermore, the MMS tablets are expensive compared to the IFA, which might hinder the uptake of the MMS by the people. c. Relevance: Based on the WHO recommendation, CIFF awarded the Social Marketing Company (SMC) to set up a sustainable business model with affordable and quality MMS to pregnant women in Bangladesh over a period of 5 years through SMC's pharmacy networks. The investigators propose to develop an evaluation design including both process and outcome evaluation to evaluate the implementation and effect of the MMS by the SMC in Bangladesh.

Hypothesis: The prevalence of LBW will be reduced by 5% point in the intervention group compared to the control group by the end of the 5-year program.

Objectives: Outcome evaluation- To evaluate the effectiveness of market-based distribution of MMS intervention on the prevalence of low birth weight (less than 2500 g) in the infants born to women in the intervention area who received the intervention compared to control areas Process evaluation- To measure the fidelity, reach and mechanism of impact of the intervention

Methods: The evaluation study will comprise both process and outcome evaluation, complementing each other. The design will be a quasi-experimental cluster-based open cohort, two-arm, mixed-methods design. The evaluation would take place in 5 divisions of Bangladesh: Barishal, Chattogram, Dhaka, Rajshahi, and Sylhet. For outcome evaluation: Eligible pregnant women will be approached for recruitment with proper consent. Right after recruitment, a baseline data collection will be conducted using a structured questionnaire along with anthropometric measurements. The recruited participants will be followed up until the end of their pregnancy. After successful delivery of a baby, an endpoint data collection will be done along with birth weight measurement of the baby. Data from the control areas will be collected following the same guideline to maintain consistency. The process evaluation will be carried out concurrently to monitor the program activities. This will follow a mixed-method design, including both quantitative and qualitative components. The participants will be recruited from the same area where activity for outcome evaluation will be ongoing. The investigators will focus on the fundamental aspects of process evaluation that includes- (a) understanding the health promotion program and how it is supposed to work, (b) defining the purposes for the process evaluation, and (c) considering program characteristics and context and how these may affect implementation.

Outcome measures/variables: The key variable for outcome evaluation is the measurement of birth weight. Key variables for process evaluation are fidelity, reach, and mechanism of impact of the intervention (MMS).

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy identified/reported through ultrasonogram during ANC or other available medical proof
* Absence of severe malnourishment/known chronic diseases- respiratory illness, hypertension, diabetes, TB, haemoglobinopathy, etc. through self-reporting and available documents
* Participant willingness to participate
* Provide at least two mobile numbers to contact
* The place of delivery has been decided

Exclusion Criteria:

* Non-pregnant
* Declined to participate

Primary outcomes:
measure: Percentage of Low birth weight babies
timeFrame: November 2021 to June 2024
Secondary outcomes:
measure: Percentage of Preterm children
timeFrame: November 2021 to June 2024
measure: Number of pregnant women with MMS side effects, compliance, & adverse perinatal outcomes
timeFrame: November 2021 to June 2024
measure: Percentages of contact and effective coverage for the intervention group
timeFrame: November 2021 to June 2024
measure: Number of pregnant women with their duration of gestation
timeFrame: November 2021 to June 2024
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
Study officials:
affiliation: International Centre for Diarrhoeal Disease Research, Bangladesh
name: Muttaquina Hossain, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hossain M, Sanin KI, Haque MA, Mbuya MNN, Ghosh S, Aksari S, Gibson S, Neufeld L, Bipul M, Matubbar S, Rahman MM, Khondker R, Salasibew M, Ahmed T. Evaluating the impact of a countrywide, market-based roll-out of multiple micronutrient supplementation on low birth weight in Bangladesh: protocol for a two-arm, quasi-experimental and mixed-methods evaluation study. BMJ Open. 2022 May 30;12(5):e060230. doi: 10.1136/bmjopen-2021-060230.