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

Summary

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.

Conditions

• Pregnancy
• Adherence

Interventions

DIETARY_SUPPLEMENT

Bottle pack

Bottle packaging of MMS

DIETARY_SUPPLEMENT

Blister pack

Blister packaging of MMS

OTHER

Standard Care

Standard ANC and PNC services, regular health promotion and printed material

OTHER

Digital care

In addition to standard care, participants get intervention such as: Daily automated and personalized WhatsApp reminders, Whatsapp MMS consumption reminder, call center, personalized education via chatbot and consultations, gamification and alert system, AI monitoring and prediction

Sponsors & Collaborators

• Children's Investment Fund Foundation

  collaborator OTHER

• Sight and Life Foundation

  collaborator UNKNOWN

• Summit Institute for Development, Indonesia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

14 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-06-13

Primary Completion

2027-05-31

Completion

2027-06-30

Countries

• Indonesia

Study Locations