Antenatal multiple micronutrient supplementation in Indonesia
Implementation Research to Accelerate Multiple Micronutrient Supplementation During Pregnancy in Indonesia
This study is testing different ways to provide multiple micronutrient supplements to pregnant women in Indonesia to see if it can improve their nutrition and the health of their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3688 (estimated) |
| Sex | All |
| Sponsor | Johns Hopkins Bloomberg School of Public Health Academic / other |
| Locations | 1 site (Jakarta) |
| Trial ID | NCT06225791 on ClinicalTrials.gov |
What this trial studies
This research aims to implement and scale antenatal multiple micronutrient supplements (MMS) within Indonesia's national health system to enhance maternal nutrition and improve birth outcomes. The study will evaluate various MMS delivery strategies, including different packaging options and behavior change communication (BCC) methods, to determine their effectiveness in promoting adherence to supplementation. Both qualitative and quantitative methods will be employed to assess the acceptability, feasibility, and fidelity of the MMS program within antenatal care services. The study will involve approximately 3,360 pregnant women enrolled in antenatal care and will focus on optimizing the delivery of MMS.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women enrolled in antenatal care at government health facilities with a gestational age of 20 weeks or less.
Not a fit: Patients with complicated pregnancy conditions or those planning to move outside the study district during the study period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve maternal nutrition and birth outcomes for pregnant women in Indonesia.
How similar studies have performed: Other studies have shown success with similar approaches to micronutrient supplementation, indicating potential for positive outcomes in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1) * 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. Exclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1) * PW with complicated pregnancy complications (e.g., thalassemia, hemochromatosis,) * PW planning to move outside study district during study period. Inclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2) * 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 Exclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2) * Enrolled in Sample 1 * Women who are more than 4 weeks postpartum. Inclusion Criteria for 180 healthcare providers participating in focus group discussions (FGDs) (sample group 3) * 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. Exclusion Criteria for 180 healthcare providers participating in FGDs (sample group 3) • Healthcare Providers who have already participated in a FGD will not be eligible to participate in another FGD Inclusion Criteria for 76 government decision-makers participating in FGD or IDI (sample group 4) * 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 for 76 government decision-makers participating in FGD or IDI (sample group 4) • None
Where this trial is running
Jakarta
- Universitas Indonesia — Jakarta, Indonesia (Recruiting)
Study contacts
- Principal investigator: Endang Achadi, PhD — Indonesia University
- Study coordinator: Trisari Anggondowati, PhD
- Email: trisari.a@gmail.com
- Phone: +62 819-9988-1057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.