Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia

NCT ID: NCT06225791

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-25
• Study Completion Date: 2025-03-17

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)

Detailed Description

The study will utilize qualitative and quantitative methods to:

• Test different MMS delivery strategies (bottle count [90 vs. 180 tablets] and communication strategies [BCC vs. expanded BCC vs. MMS orientation only]) for enhancing supplementation consumption - measured as coverage and adherence.
• Assess acceptability, feasibility, and fidelity of MMS program implementation within antenatal care services (ANC)

More specifically, the investigators will implement and evaluate different MMS packaging (90 count bottle vs 180-count bottle) strategies and behavior change communication (BCC) strategies. The 3 BCC approaches are further described below.

• BCC, BCC without Interpersonal Communication (IPC) strategy is a briefer more basic approach that hopes to improve health care providers knowledge about MMS and the providers ability to communicate with pregnant women. This approach will be rolled out by training one district-level facilitator in each district to become a trainer who will be responsible for training health providers in the corresponding study sub-districts.
• Expanded BCC ('BCC with Interpersonal Communication [IPC]') needs more intensive training of master trainers to train health care providers and focuses more on the counselling skills portion. The BCC without IPC is more feasible to implement within the existing system, the investigators anticipate that the BCC with IPC achieve better behavior change results.
• MMS Orientation: Women in the control group will receive the existing standard of counselling care. The providers will not be given any sort of training on counselling. Due to the fact that MMS is a new product that the providers will be providing pregnant women, all health care providers will receive a standard MMS orientation so providers are comfortable with the new supplement.

The study will be conducted in 25 districts representing the western, central, and eastern regions of Indonesia, Indonesia's socio-cultural diversity, and varying capacity of ANC systems across districts. After selection, the 25 districts were divided to receive high-intensity (8 districts), moderate-intensity (5 districts), or low-intensity (12 districts) evaluation activities with those exposed to high-intensity evaluation efforts having comprehensive individual-level data collected by study employed data collectors while the low-and moderate-intensity district data collection efforts are being done within the context of the existing health system.

1. High intensity evaluation areas (8 districts) Evaluation of MMS acceptability, coverage, adherence, feasibility, and fidelity will include data collection from health professionals and pregnant women by study data collectors, and by ANC monitoring activities.

2. Moderate intensity evaluation areas (5 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, data collectors will collect MMS acceptability, feasibility, and fidelity data within 2 of those 5 districts.

3. Low intensity evaluation area (12 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, a household coverage survey will be administered in a subset of districts (n=6) post-intervention to examine MMS acceptability, adherence, coverage, and implementation feasibility and fidelity. The coverage survey will be designed after 6 months of implementation and will be submitted as a separate application to the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, and a separate entry into Clinicaltrials.gov.

Within the 8 high-intensity districts and 5 moderate-intensity districts that are the subject of this Clinicaltrials.gov submission, the study will utilize a three-arm cluster randomized design (with sub-district health center as the unit of randomization).

Conditions

Nutrient Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard MMS delivery with two 90-count bottles

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Enhanced MMS delivery with two 90-count bottles

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).

Group Type: ACTIVE_COMPARATOR

MMS (90x2) + BCC or expanded BCC

Intervention Type: 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 one 180-count bottle

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).

Group Type: ACTIVE_COMPARATOR

MMS (180x1) + BCC or expanded BCC

Intervention Type: 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)

Interventions

MMS (90x2) + BCC or expanded BCC

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)

Intervention Type: BEHAVIORAL

MMS (180x1) + BCC or expanded BCC

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)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.
• Willing to give consent to participate in the FGD or IDI.

Exclusion Criteria

• PW with complicated pregnancy complications (e.g., thalassemia, hemochromatosis,)
• PW planning to move outside study district during study period.

• Enrolled in Sample 1
• Women who are more than 4 weeks postpartum.

• None

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: collaborator

Hasanuddin University

OTHER

Sponsor Role: collaborator

Universitas Airlangga

OTHER

Sponsor Role: collaborator

Vitamin Angels

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Endang Achadi, PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Kristin Hurley, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

Universitas Indonesia

Jakarta, , Indonesia

Countries

Indonesia

Other Identifiers

IRB00016428 / MOD00004017

Identifier Type: -

Identifier Source: org_study_id