Evaluation of an Intervention for Optimizing Pregnant Women's Adherence to Maternal Multiple Micronutrients Supplements

In collaboration with the Federal Government of Nigeria and Bauchi State, Nutrition International (NI) conducted a three-year implementation research study to assess whether adherence solutions - developed through a human-centered designed (HCD) approach - could improve adherence to multiple micronutrient supplementation (MMS) among pregnant women in Nigeria. These set of adherence solutions focused on strengthening the capacity of healthcare workers and community members, improving nutrition counselling within antenatal care, and engaging pregnant women' family members to support consistent MMS intake.

Study Overview

• Status: Completed
• Conditions: Pregnancy; Adherence
• Intervention / Treatment: Behavioral: Implementation Approaches

Detailed Description

Research has shown that antenatal multiple micronutrient supplementation (MMS), a daily dose of 15 vitamins and minerals, is just as effective as iron and folic acid supplementation (IFAS) in preventing maternal anaemia, more effective at improving birth outcomes and is safe for mothers and babies.

In 2020, the World Health Organization (WHO) released an updated guidance recommending that implementation research (IR) be conducted in settings where the transition from IFAS to MMS is being considered in low- and middle- income countries. IR can help countries understand how to best design and implement effective intervention in real-life settings and can be used to identify and investigate challenges that prevent effective implementation.

In line with the WHO's recommendation, in 2021, the Nigeria Federal Ministry of Health approved the use of MMS during pregnancy and called for implementation research (IR) in the updated National Guidelines for the Prevention and Control of Micronutrient Deficiencies in Nigeria.

Based on national stakeholders' identification of a critical need for context-specific implementation evidence, efforts focused on understanding how MMS can be effectively delivered, accepted, and adhered to within the Nigerian health system, particularly in light of the implementation bottlenecks and adherence gaps previously documented in IFAS programs.

This IR project aims to evaluate implementation approaches on optimizing pregnant women's adherence to MMS. One of the components of this IR project is an outcome evaluation - the focus of this protocol - that seeks to answer the following research questions:

Primary research questions:

• Does implementation of these implementation approaches increase pregnant women's adherence to MMS?

Secondary research questions:

• Are the implementation approaches acceptable to key stakeholders?
• Does implementation of the implementation approaches increase the quality of care/nutrition counseling in ANC?

The implementation approaches focused on:

• Strengthening the capacity building of healthcare workers and community members
• Improving nutrition counselling integrated into ANC delivery with an emphasis on MMS adherence
• Engaging pregnant woman's family members (husbands) and influential community members to support maternal health and nutrition

An outcome evaluation was completed using a cluster randomized controlled trial (cRCT) with cross-sectional baseline (prior to the introduction of the implementation approaches) and endline (approximately 2 years after the introduction of the introduction of the implementation approaches) surveys among pregnant women, their husbands and healthcare workers (HCWs) across the three Local Government Areas (LGAs) in Bauchi State. MMS was integrated into routine ANC across the state prior to the baseline assessment.

Nutrition International worked closely with the Bauchi state government to select 3 LGAs (Dass, Ganjuwa and Giade) representing the north, central and southern parts of the state. This decision was made taking into consideration state representation key criteria such as religious demographic, ANC attendance, security, IFA utilization and socio-economic distribution. These LGAs comprise a total of 42 wards all of which were designated as study clusters for the intervention and control arms. Out of these 42 wards, a simple random selection was used to randomly allocate 22 wards to the intervention arm and 20 to the control arm across the three target LGAs:

• Control arm: Eligible pregnant women in these study sites receive MMS as part of their standard ANC.
• Intervention arm: Eligible pregnant women in these study sites receive MMS alongside the implementation approaches as part of their standard ANC.

A third observational arm was selected from a separate LGA where MMS had not been introduced and IFAS continued to be the standard of care to help contextualise differences between the intervention and control arms.

Quantitative and qualitative data were collected from participants through interviewer-administered questionnaires and focus group discussions. The study measured adherence through several methods including self-reported daily consumption, average consumption rate over a three-month period, and a physical pill count by the data collector. Difference-in-difference analysis will be used to assess whether the implementation approaches increased MMS adherence at endline. Descriptive statistics will be used to determine whether the adherence solutions are acceptable to healthcare workers, pregnant women, and their husbands.

• Study Type: Interventional
• Enrollment (Actual): 2601
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Bauchi
    • Dass, Bauchi, Nigeria
      • Public health facilities in Dass
    • Ganjuwa, Bauchi, Nigeria
      • Public health facilities in Ganjuwa
    • Giade, Bauchi, Nigeria
      • Public health facilities in Giade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Pregnant/post-partum women

• Women of reproductive age (15-49 years of age)
• Pregnant or up to 3 months post-partum women
• Having reportedly received at least one MMS bottle at least 30 days before start of data collection from a participating public health facility-
• Provide consent for participation

Health Care Workers (HCWs)

• HCWs providing ANC services including MMS and IFAs to pregnant women at the selected health facilities

Husbands

• Husbands of the enrolled pregnant women At endline, the same criteria apply.

Exclusion Criteria:

• Anemic pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control arm
Experimental: Intervention Arm; Eligible pregnant women received implementation approaches	Behavioral: Implementation Approaches; Implementation approaches are human-centered designed strategies aimed at optimizing pregnant women's daily adherence to MMS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to MMS	Defined as "when pregnant women consume the right dose of multiple micronutrient supplementation (MMS) at the right time throughout pregnancy". Measured through self-reported daily consumption, self-reported average consumption rate over a three-month period, and pill count.	At baseline and approximately 2 years after (endline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Defined as stakeholders' attitude towards MMS and its introduction as part of ANC. Assessed through surveys (Likert scale). The Likert scale is a 5 point scale quantifying attitudes from "strongly agree" to "strongly disagree".	At baseline and approximately 2 years after (endline)

Collaborators and Investigators

• Sponsor: Nutrition International
• Investigators: Principal Investigator: Babajide Adebisi, Nutrition International; Principal Investigator: Jennifer Busch Hallen, Nutrition International

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): May 26, 2025
• Study Completion (Actual): May 26, 2025

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; pregnant women; Nigeria; Antenatal care; ANC; implementation research; maternal nutrition; MMS; Multiple Micronutrient Supplementation; maternal supplementation
• Other Study ID Numbers: NI-07-2023-MMSN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Published IPD will be shared upon reasonable request
• IPD Sharing Time Frame: May 2026 for 3 years.
• IPD Sharing Access Criteria: Access to the data will be restricted to the data collectors and study team, both of whom will sign a confidentiality agreement. When transmitting this data to investigators approved for this study, anonymized datasets will then be sent by encrypted zipped file in Stata format, The password to access these files will be communicated separately using email. The encryption keys will be transferred in the same way to co-investigators, if and as needed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No