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

NCT07555093 | Not Yet Recruiting

• 2 other identifiers: 081/UN18.F8/ETIK/2025023/SID/Agr/IV/2025
• Study Type: interventional
• Target: 10,012
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does a digitally supported intervention increase adherence to MMS compared to standard care?
2. 2.Does the type of MMS packaging (bottle vs. blister) affect adherence?
3. 3.In the second stage, does adding calcium supplementation affect adherence to MMS?
4. 4.Standard care with MMS in bottles
5. 5.Standard care with MMS in blister packs
6. 6.Digital intervention with MMS in bottles
7. 7.Digital intervention with MMS in blister packs
8. 8.Receive MMS through either bottle or blister packaging
9. 9.Receive either standard care or a digital health intervention (such as reminders or digital support tools)
10. 10.Attend routine antenatal care services
11. 11.Be followed throughout pregnancy, delivery, and up to 42 days after childbirth

Conditions

Pregnancy; Adherence

Keywords

MMS; Pregnancy; Digitalization; adherence; Antenatal Care

Outcome Measures

Primary Outcomes (1)

• MMS consumption Adherence

  Adherence is defined as the proportion of recommended daily MMS doses consumed over the total number of follow-up days, measured from enrolment until delivery (up to approximately 280 days of gestation). Adherence will be assessed using digital tracking data (QR code scans), self-reports, and/or supplement counts. Data will be collected monthly, and the final adherence value will be calculated as the mean of monthly adherence measurements per participant. Comparisons will be conducted across four study arms: (1) digital care with blister packaging, (2) standard care with bottle packaging, (3) standard care with blister packaging, and (4) digital care with bottle packaging.

  Since enrolment until delivery (up to approximately 280 days of gestation), with monthly assessments

Secondary Outcomes (26)

• Gestational Age at Birth

  Birth

• Proportion of Preterm Birth

  Birth

• Proportion of Very and Extremely Preterm Birth

  Birth

• Proportion of Post-term Birth

  Birth

• Proportion of Stillbirth

  Birth

Study Arms (4)

Digital Care with Blister

EXPERIMENTAL

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

Dietary Supplement: Blister pack; Other: Digital care

Standard Care with Bottle

ACTIVE COMPARATOR

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.

Dietary Supplement: Bottle pack; Other: Standard Care

Standard Care with Blister

ACTIVE COMPARATOR

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.

Dietary Supplement: Blister pack; Other: Standard Care

Digital Care with Bottle

EXPERIMENTAL

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

Dietary Supplement: Bottle pack; Other: Digital care

Interventions

Bottle pack DIETARY_SUPPLEMENT

Bottle packaging of MMS

Digital Care with Bottle; Standard Care with Bottle

Blister pack DIETARY_SUPPLEMENT

Blister packaging of MMS

Digital Care with Blister; Standard Care with Blister

Standard Care OTHER

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

Standard Care with Blister; Standard Care with Bottle

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

Digital Care with Blister; Digital Care with Bottle

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women up to 32 weeks
• Pregnant women stay in the site at least during the study period

You may not qualify if:

• Lost to follow up
• Moving to another area
• Death
• Abortus
• Stillbirth

Sponsors & Collaborators

• Summit Institute for Development, Indonesia: lead
• Children's Investment Fund Foundation: collaborator
• Sight and Life Foundation: collaborator

Study Sites (1)

Summit Institute for Development

Mataram, West Nusa Tenggara, 83239, Indonesia

Location

Related Publications (33)

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MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Yuni Dwi Setiyawati, MHID

CONTACT

+6285337006810; yuni.setiyawati@sid-indonesia.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Executive Officer

Model Details: Standard care with MMS in bottles Standard care with MMS in blister packs Digital intervention with MMS in bottles Digital intervention with MMS in blister packs

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: April 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available upon reasonable request beginning 6 months after the publication of the primary results and will remain available for up to 3 years, or as long as ethically and legally permissible, in accordance with institutional and national data protection policies.
• Access Criteria: Qualified researchers may request access to de-identified individual participant data (IPD) and related documentation. Requests must be submitted in writing to the Principal Investigator and/or lead research organization (SID) and include a detailed research proposal outlining the purpose of the data use, analysis plan, intended collaborators, and publication strategy. Each request will be assessed and approved based on scientific merit, ethical compliance, and data protection considerations. Approved requesters will be required to sign a data use agreement. SID must be involved in all stages of the process, including preparation, analysis, manuscript writing, and publication.

Locations

ID (1)