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

Sponsor
Summit Institute for Development, Indonesia
Study ID
NCT07555093
Status
Recruiting
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Conditions

  • Adherence
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
14 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Bottle pack — DIETARY_SUPPLEMENT
    Bottle packaging of MMS
  • Blister pack — DIETARY_SUPPLEMENT
    Blister packaging of MMS
  • Standard Care — OTHER
    Standard ANC and PNC services, regular health promotion and printed material
  • Digital care — OTHER
    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

Study Details

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.

Key Dates

First listed
Apr 29, 2026
Start date
Jun 13, 2026
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
10,012 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER

Arms

  • Experimental: Digital Care with Blister
    Participant will get All Standard Care components, MMS provided in blister packaging, 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
  • Active Comparator: Standard Care with Bottle
    Participant will receive standard ANC and PNC services, regular health promotion and printed material, MMS provided in bottle packaging, and no digital adherence support is provided.
  • Active Comparator: Standard Care with Blister
    Participant will receive standard ANC and PNC services, regular health promotion and printed material, MMS provided in blister packaging, no digital adherence support is provided.
  • Experimental: Digital Care with Bottle
    Participant will get all standard care components, MMS provided in bottle form, daily automated am personalized WhatsApp reminders, WhatsApp MMS consumption reminder, call center, personalized education via chatbot and consultations, gamification and alert system, AI monitoring and prediction

Primary Outcome Measure

MMS consumption Adherence [ Time Frame: Since enrolment until delivery (up to approximately 280 days of gestation), with monthly assessments ]

Central Contacts

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