Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia

NCT06225791 | Completed

• 1 other identifier: IRB00016428 / MOD00004017
• Study Type: interventional
• Target: 5,384
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Indonesian national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:

• Examine different MMS delivery strategies (i.e., packaging strategies and behavior change communication (BCC) strategies) in relation to MMS adherence.
• Assess acceptability, feasibility, fidelity, and coverage of MMS program implementation within antenatal care services (ANC)

Conditions

Nutrient Deficiency

Keywords

multiple micronutrient supplementation (MMS); pregnancy; behavior change; packaging; antenatal care (ANC)

Outcome Measures

Primary Outcomes (2)

• MMS Adherence (amount)

  The number of MMS tablets (from a total possible 180 tablets) a pregnant woman consumes (sample group 1).

  Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks

• MMS Adherence (frequency)

  The frequency of which MMS tablets are consumed by a pregnant woman. (sample group 1)

  Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks

Secondary Outcomes (3)

• MMS Acceptability among Pregnant Women

  Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks

• MMS Acceptability among Health Providers assessed by focus group discussions

  6 months, 12 months

• Fidelity of providing MMS among Health Providers as assessed by focus group discussions

  6 months, 12 months

Other Outcomes (2)

• Number of pregnant women being given 180 tablets of MMS

  Monthly up to 18 months

• Number of MMS tablets consumed

  Monthly up to 18 months

Study Arms (3)

Standard MMS delivery with two 90-count bottles

NO INTERVENTION

Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with standard MMS delivery strategy (MMS orientation only). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation).

Enhanced MMS delivery with two 90-count bottles

ACTIVE COMPARATOR

Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation).

Behavioral: MMS (90x2) + BCC or expanded BCC

Enhanced MMS delivery with one 180-count bottle

ACTIVE COMPARATOR

Pregnant women are provided with one 180-count bottle of MMS along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 with MMS orientation with expanded BCC). (1 sub-district with each of the 13 districts with high- or moderate-intensity evaluation).

Behavioral: MMS (180x1) + BCC or expanded BCC

Interventions

MMS (90x2) + BCC or expanded BCC BEHAVIORAL

Provision of 90-count bottles x 2, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC)

Enhanced MMS delivery with two 90-count bottles

MMS (180x1) + BCC or expanded BCC BEHAVIORAL

Provision of 180-count bottles x 1, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC)

Enhanced MMS delivery with one 180-count bottle

Eligibility Criteria

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

You may qualify if:

• Enrolled in ANC 1 through government health facilities.
• Received MMS at ANC 1
• Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
• Consent provided to participate in the study.

You may not qualify if:

• PW with complicated pregnancy complications (e.g., thalassemia, hemochromatosis,)
• PW planning to move outside study district during study period.
• Enrolled in ANC 1 through government health facilities.
• Received MMS at ANC 1
• Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
• Consent provided to participate in qualitative component of study.
• Received MMS for at least 3 months.
• Attended \> 2 ANC visits.
• \< 4 weeks post-partum
• Enrolled in Sample 1
• Women who are more than 4 weeks postpartum.
• Government health workers who provide ANC services (e.g., midwives, general practitioners, and nutritionists)
• Government health facility management staff (e.g., Head of Puskesmas Community Health Clinic, Coordinating Midwife, Head of Pharmacy)
• Willing to give consent to participate in the FGD.
• District-, provincial-, or national-level decision-makers working in nutrition, maternal, newborn and child health, or pharmaceutical roles associated with the antenatal care system in Indonesia.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Indonesia University: collaborator
• Hasanuddin University: collaborator
• Universitas Airlangga: collaborator
• Vitamin Angels: collaborator

Study Sites (1)

Universitas Indonesia

Jakarta, Indonesia

Location

Study Officials

• Endang Achadi, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

• Kristin Hurley, PhD, MPH

  Johns Hopkins Bloomberg School of Public Health

  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

Model Details: MMS will be implemented across 13 districts in Indonesia. In each of the 8 high-intensity evaluation districts and 5 moderate-intensity evaluation districts, 3 study arms/sub-districts have been purposively selected (total n = 24 sub-districts). * Arm/sub-district 1: Provision of 90-count bottles x 2, with standard MMS delivery strategies and MMS orientation * Arm/sub-district 2: Provision of 90-count bottles x 2, with enhanced MMS deliveries strategy (3 with MMS orientation with BCC; 5 with MMS orientation with expanded BCC) * Arm/sub-district 3: Provision of 180-count bottles x 1, with enhanced MMS delivery strategy (3 with MMS orientation with BCC; 5 with MMS orientation with expanded BCC)

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 26, 2024
• Study Start: December 25, 2023
• Primary Completion: January 31, 2025
• Study Completion: March 17, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)