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

NCT07644780 | Completed

• 1 other identifier: NI-07-2023-MMSN
• Study Type: interventional
• Target: 2,601
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Adherence; Pregnancy

Keywords

MMS; Adherence; Antenatal care; maternal supplementation; Nigeria; maternal nutrition; pregnant women; implementation research; ANC; Multiple Micronutrient Supplementation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability

  At baseline and approximately 2 years after (endline)

Study Arms (2)

Control arm

NO INTERVENTION

Intervention Arm

EXPERIMENTAL

Eligible pregnant women received implementation approaches

Behavioral: Implementation Approaches

Interventions

Implementation Approaches BEHAVIORAL

Implementation approaches are human-centered designed strategies aimed at optimizing pregnant women's daily adherence to MMS.

Intervention Arm

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anemic pregnant women

Sponsors & Collaborators

• Nutrition International: lead

Study Sites (3)

Public health facilities in Dass

Dass, Bauchi, Nigeria

Location

Public health facilities in Ganjuwa

Ganjuwa, Bauchi, Nigeria

Location

Public health facilities in Giade

Giade, Bauchi, Nigeria

Location

Study Officials

• Babajide Adebisi

  Nutrition International

  PRINCIPAL INVESTIGATOR

• Jennifer Busch Hallen

  Nutrition International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: June 12, 2026
• Study Start: March 7, 2024
• Primary Completion: May 26, 2025
• Study Completion: May 26, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: May 2026 for 3 years.
• 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.

Locations

NG (3)