A Study of Multiple Micronutrient Supplementation (MMS) to Increase Adherence With Digital Technology

The goal of this randomized clinical trial is to learn whether a digital health intervention can improve adherence to Multiple Micronutrient Supplementation (MMS) among pregnant women in Lombok Island. The study also aims to understand how individual characteristics, socio-economic factors, maternal health status, and antenatal care services influence adherence to MMS. The main questions it aims to answer are: 1. Does a digitally supported intervention increase adherence to MMS compared to standard care? 2. Does the type of MMS packaging (bottle vs. blister) affect adherence? 3. In the second stage, does adding calcium supplementation affect adherence to MMS? Researchers will compare four groups to see if digital support and packaging type improve MMS adherence: 1. Standard care with MMS in bottles 2. Standard care with MMS in blister packs 3. Digital intervention with MMS in bottles 4. Digital intervention with MMS in blister packs Approximately 10,012 pregnant women will be randomly assigned to one of these four groups using a 2×2 factorial design. Participants will: 1. Receive MMS through either bottle or blister packaging 2. Receive either standard care or a digital health intervention (such as reminders or digital support tools) 3. Attend routine antenatal care services 4. Be followed throughout pregnancy, delivery, and up to 42 days after childbirth In the second stage of the study, participants from community health posts (Posyandu) will also receive calcium supplementation in addition to MMS. Additional 900 pregnant women will be enrolled from the same Puskesmas areas participating in the MMS study to evaluate the addition of calcium supplementation. These participants will be recruited outside of the main MMS cohort and will be equally distributed across the four study arms. This stage aims to assess whether adding calcium supplementation influences adherence to MMS among pregnant women. Participants will be monitored during pregnancy, at delivery, and during the postnatal care period up to 42 days after birth. This study represents an early implementation of Multiple Micronutrient Supplementation (MMS) in Lombok Island, where MMS is not yet routinely available through government programs. Only selected primary healthcare centers (Puskesmas) that are randomized into the study will provide MMS to eligible participants. While the government has begun introducing MMS in other areas, it has not yet been implemented in Lombok. The digital health intervention will only be provided to pregnant women who agree to participate in the study and provide informed consent. All participants will continue to receive standard antenatal care (ANC) services in accordance with existing government programs. This study is also integrated with the ongoing distribution of iron and folic acid supplementation (TTD) in Lombok. Pregnant women who do not consent to participate in the study or do not receive MMS will continue to receive TTD as part of routine care outside of the study.

NCT Number	NCT07555093
Lead Sponsor	Summit Institute for Development, Indonesia Collaborators: Children's Investment Fund Foundation, Sight and Life Foundation
Conditions	Pregnancy, Adherence
Enrollment	10,012 participants
Start Date	2026-06-13
Primary Completion	2027-05 (estimated)
Study Completion	2027-06 (estimated)
Updated on ClinicalTrials.gov	2026-07-01