PregnancySMART-MMSNCT07555093
A Study of Multiple Micronutrient Supplementation (MMS) to Increase Adherence With Digital Technology
A study testing Bottle pack, Blister pack and Digital care in people with Pregnancy and Adherence, run by Summit Institute for Development, Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Bottle pack, Blister pack and Digital care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,012 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women up to 32 weeks
- Pregnant women stay in the site at least during the study period
Who cannot join
- Lost to follow up
- Moving to another area
- Death
- Abortus
- Stillbirth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Summit Institute for Development
Mataram, West Nusa Tenggara, 83239
Yuni Dwi Setiyawati, MHID, +6285337006810, yuni.setiyawati@sid-indonesia.org
About this study
Official title: A Randomized Controlled Trial in Lombok: Assessing Factors Influencing Acceptance and Adherence to Multiple Micronutrient Supplementation (MMS) Using Digital Tools
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:
Read more
- Does a digitally supported intervention increase adherence to MMS compared to standard care?
- Does the type of MMS packaging (bottle vs. blister) affect adherence?
- 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:
- 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
Approximately 10,012 pregnant women will be randomly assigned to one of these four groups using a 2×2 factorial design.
Participants will:
- Receive MMS through either bottle or blister packaging
- Receive either standard care or a digital health intervention (such as reminders or digital support tools)
- Attend routine antenatal care services
- 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.
Read the detailed description
This study is a nested (two-stage) cluster-randomized controlled trial conducted in Lombok Island, designed to evaluate strategies to improve adherence to Multiple Micronutrient Supplementation (MMS) among pregnant women, as well as to assess the feasibility of integrating calcium supplementation into the MMS program within routine health systems.
The first stage of the study consists of a cluster randomized trial at the puskesmas (primary healthcare center) level. Puskesmas are randomized into four intervention arms to evaluate the effectiveness of different delivery approaches for MMS, specifically comparing combinations of digital and non-digital strategies, as well as packaging formats. The digital intervention includes mobile-based tools such as WhatsApp reminders, chatbot-assisted education, call center support, and a gamified alert system to encourage adherence. Artificial intelligence-based approaches, including adherence monitoring and prediction models, will also be explored. The non-digital group receives standard antenatal and postnatal care services, including routine health promotion and printed educational materials.
The second stage involves a cluster randomized trial at the posyandu (community health post) level within selected puskesmas. This stage evaluates the addition of calcium supplementation to MMS compared with MMS alone. Additional pregnant women will be enrolled outside the main MMS cohort and distributed across study arms. This component aims to assess the feasibility, acceptability, and operational considerations of co-administering calcium alongside MMS within the existing health system.
To support implementation across both study components, several operational and digital systems will be applied. Each supplement package will be labeled with a unique QR code to enable real-time tracking of supplement distribution and consumption through KoboToolbox. A Dynamic Worker Support (DWS) system will be implemented to assist Community Health Promoters in automated scheduling, task management, and field activity optimization.
Sample Size and Statistical Considerations
The sample size has been calculated based on the primary outcome of MMS adherence, accounting for clustering effects at both puskesmas and posyandu levels. Approximately 10,012 pregnant women will be enrolled in Stage 1 across 60 puskesmas clusters. In Stage 2, approximately 900 additional participants will be recruited to evaluate calcium co-supplementation. The sample size is designed to ensure adequate statistical power to detect meaningful differences between study groups.
A comprehensive quality assurance framework will be implemented to ensure data integrity, accuracy, and consistency across all study sites. Electronic data capture systems (KoboToolbox) will incorporate built-in validation rules, including range checks, consistency checks, and logical constraints across related variables. In addition, data validation will be strengthened through a double data entry process, whereby selected records are entered independently by two data entry personnel and discrepancies are identified and resolved through predefined verification procedures.
Routine centralized data monitoring will be conducted to assess data completeness, timeliness, and internal consistency. In addition, quality assurance (QA) activities will be implemented to assess field staff performance through direct verification. This includes periodic visits by QA staff to pregnant women to validate home visit activities conducted by field workers. QA may also be conducted through HealthComm by contacting participants to confirm services received and ensure consistency with reported data. These procedures aim to ensure adherence to study protocols, verify implementation fidelity, and maintain overall data quality.
A standardized data management system will be implemented, including a comprehensive data dictionary that defines all study variables, formats, permissible values, coding structures, and data sources. Where applicable, standardized coding approaches will be applied to ensure consistency.
All study procedures will be guided by Standard Operating Procedures (SOPs) and a detailed field manual to ensure standardized implementation across sites. The field manual provides step-by-step operational guidance for field staff, including participant recruitment, informed consent procedures, home visit protocols, supplement distribution, digital system utilization, and data collection processes.
It also outlines procedures for data management, adverse event reporting, and communication workflows between field teams and supervisors. Field staff, including Community Health Promoters, will receive structured training and ongoing supervision based on the field manual to ensure consistent, accurate, and high-quality implementation throughout the study.
Data quality checks during data collection will aim to minimize missingness. During analysis, appropriate statistical techniques, such as multiple imputation or sensitivity analyses, will be applied as specified in the statistical analysis plan.
All analyses will follow the intention-to-treat principle. Primary analyses will assess adherence to MMS across intervention arms using mixed-effects regression models to account for cluster randomization and potential confounders. The factorial design allows estimation of the independent and interaction effects of digital intervention and packaging type.
Secondary analyses will examine factors influencing adherence, maternal and neonatal outcomes, and the impact of calcium co-supplementation. Depending on the nature of the outcome variables, appropriate generalized linear (mixed-effects) models will be employed. Binary outcomes will be analyzed using mixed-effects logistic regression models, continuous outcomes using linear mixed-effects models, and count or proportion outcomes using Poisson or binomial-based models with appropriate link functions. All models will account for clustering at the study design level and adjust for relevant covariates. Subgroup and sensitivity analyses will be conducted to assess the robustness and generalizability of the findings.
- Being tested
- Bottle pack, Blister pack, Standard Care, Digital care
- Keywords
- MMS, Pregnancy, Digitalization, adherence, Antenatal Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bottle packDietary supplement
Bottle packaging of MMS
Blister packDietary supplement
Blister packaging of MMS
Standard CareOther
Standard ANC and PNC services, regular health promotion and printed material
Digital careOther
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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 Receives: Dietary Supplement: Bottle pack; Other: Digital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Since enrolment until delivery (up to approximately 280 days of gestation), with monthly assessments
Secondary outcomes (26)
Gestational Age at Birth
Gestational age (GA) will be calculated in completed weeks based on first-trimester ultrasound where available (preferred), or last menstrual period if ultrasound is unavailable. Mean GA at delivery will be reported.
Measured: Birth
Proportion of Preterm Birth
Proportion of live births occurring at <37 completed weeks of gestation.
Measured: Birth
Proportion of Very and Extremely Preterm Birth
Proportion of pregnancies delivered before these gestational age: at <34 weeks, <32 weeks, and <28
Measured: Birth
Proportion of Post-term Birth
Proportion of live births occurring at >42 completed weeks of gestation.
Measured: Birth
Proportion of Stillbirth
Proportion of pregnancies resulting in fetal death ≥28 weeks of gestation occurring before or during labor and before complete expulsion or extraction.
Measured: Birth
Perinatal Mortality
Stillbirth (≥28 weeks gestation) or death of a liveborn infant within 7 completed days of birth.
Measured: Within 28 weeks of gestation to 7 days of birth
Neonatal Mortality
Death of a liveborn infant within 28 completed days of birth.
Measured: Within 28 days of birth
Early Neonatal Mortality
Death within 7 completed days of birth.
Measured: Within 7 days of birth
Late Neonatal Mortality
Death occurs after 7 days but within 28 days of birth.
Measured: Between 7 and 28 days of birth
Birth Weight
Mean birth weight (grams), measured within 1 hour of birth using calibrated mechanical or digital scales.
Measured: Within 1 hour of birth
Proportion Low Birth Weight (LBW)
Proportion of infants with birth weight <2500 g (≤2500 g if scale increments are 100 g) among live born infants.
Measured: Within 24 hours of birth
Small for Gestational Age (SGA, 3rd Centile)
Proportion of infants with birth weight <3rd centile of INTERGROWTH-21st standards by gestational age and sex.
Measured: Within 24 hours of birth
Large for Gestational Age (LGA, 90th Centile)
Proportion of infants with birth weight (grams) >90th centile of INTERGROWTH-21st standards by gestational age and sex.
Measured: Birth
Birth Length
Mean birth length (cm).
Measured: Birth
Short for Gestational Age (10th Centile)
Proportion of infants with birth length (cm) <10th centile of INTERGROWTH-21st standards by gestational age and sex.
Measured: Birth
Short for Gestational Age (3rd Centile)
Proportion of infants with birth length (cm) <3rd centile of INTERGROWTH-21st standards by gestational age and sex.
Measured: Birth
Head Circumference
Mean head circumference at birth (cm).
Measured: Birth
Infant Sex
Proportion of male and female live births.
Measured: Birth
Length-for-age z-score (LAZ)
Mean length (cm)-for-age z-score (LAZ)
Measured: Within 28 days of birth
Weight-for-Length Z-score (WLZ)
Mean weight (gram)-for-age z-score (WAZ)
Measured: Within 28 days of birth
Weight-for-Age Z-score (WAZ)
Mean weight (gram)-for-length z-score (WLZ)
Measured: Within 28 days of birth
Stunting
Proportion of infants with Length-for-Age Z-score (LAZ) < -2 SD at 1 month. LAZ is calculated based on the WHO Child Growth Standards for infants. Lower scores indicate poorer linear growth, and a score below -2 SD is classified as stunting.
Measured: Within 28 days of birth
Wasting
Proportion of infants with Weight-for-Length Z-score (WLZ) < -2 SD at 6 months. WLZ is calculated based on the WHO Child Growth Standards for infants. Lower scores indicate acute malnutrition, and a score below -2 SD is classified as wasting.
Measured: Within 28 days of birth
Underweight
Proportion of infants with Weight-for-Age Z-score (WAZ) < -2 SD at 6 months. WAZ is calculated based on the WHO Child Growth Standards for infants.
Lower scores indicate poorer weight status, and a score below -2 SD is classified as underweight.
Measured: Within 28 days of birth
Cost effectiveness
The total cost required for each treatment group divided by The number of pregnant women who adhere with supplementation consumption in each treatment group.
Measured: Through study completion, an average of 1 year from the start of enrolment to the end of all monitoring phase
Calcium adherence
Adherence will be defined as the proportion of recommended daily doses consumed from week 20 until delivery. Dose consumption will be measured using digital tracking data (QR code scans), self-reports, and/or supplement counts where applicable. The outcome will be expressed as mean adherence proportion (%) per participant.
Measured: From 20 weeks until delivery (up to approximately 280 days of gestation), with monthly assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start13 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 10,012 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Summit Institute for Development, Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Investment Fund Foundation, Sight and Life Foundation
- Responsible party
- Principal investigator, Yuni Dwi Setiyawati, Summit Institute for Development, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555093
- Sponsor's protocol ID
- 090/UN18.F8/ETIK/2026
- Other IDs
- 023/SID/Agr/IV/2025
- Acronym
- SMART-MMS
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) requests must be submitted to the Principal Investigator and/or the lead research organization for further assessment and approval. Any request should clearly outline the purpose of data use, involved collaborators, proposed analysis plan, and intended publications. We would also like to be involved in all stages of the process, including preparation, data analysis, manuscript writing, and publication. Please note that, in principle, patient/client data belong to the respective individuals. Therefore, data sharing requires appropriate informed consent, which has been addressed in the approved study protocol. SID, as the lead research institution, will oversee and manage this process.
Publications
Battung SM, Groen H, van der Beek EM. Prenatal multiple micronutrient supplementation in the Parepare district, Indonesia; population characteristics and intake adherence. BMC Public Health. 2025 Mar 12;25(1):983. doi: 10.1186/s12889-025-22129-0.
PubMed 40075311Dwarkanath P, Muhihi A, Sudfeld CR, Wylie BJ, Wang M, Perumal N, Thomas T, Kinyogoli SM, Bakari M, Fernandez R, Raj JM, Swai NO, Buggi N, Shobha R, Sando MM, Duggan CP, Masanja HM, Kurpad AV, Pembe AB, Fawzi WW. Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy. N Engl J Med. 2024 Jan 11;390(2):143-153. doi: 10.1056/NEJMoa2307212.
PubMed 38197817Hofmeyr GJ, Betran AP, Singata-Madliki M, Cormick G, Munjanja SP, Fawcus S, Mose S, Hall D, Ciganda A, Seuc AH, Lawrie TA, Bergel E, Roberts JM, von Dadelszen P, Belizan JM; Calcium and Pre-eclampsia Study Group. Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2019 Jan 26;393(10169):330-339. doi: 10.1016/S0140-6736(18)31818-X.
PubMed 30696573Borrelli EP, Saad P, Barnes NE, Dumitru D, Lucaci JD. Improving Adherence and Reducing Health Care Costs Through Blister-Packaging: An Economic Model for a Commercially Insured Health Plan. Clinicoecon Outcomes Res. 2024 Oct 3;16:733-745. doi: 10.2147/CEOR.S480890. eCollection 2024.
PubMed 39376478Smith ER, Gomes F, Adu-Afarwuah S, Aguayo VM, El Arifeen S, Bhutta ZA, Caniglia EC, Christian P, Devakumar D, Dewey KG, Fawzi WW, Friis H, Gomo E, Guindo O, Hallamaa L, Isanaka S, Kaestel P, Lachat C, Maleta K, Moore SE, Oakley EM, Osrin D, Rahman A, Rana Z, Rizvi A, Roberfroid D, Shaikh S, Sonko B, Soofi SB, Subarkah I, Sunawang R, Wang D, West KP Jr, Wu LSF, Zagre N, Bourassa MW, Sudfeld CR. Contribution of Maternal Adherence to the Effect of Multiple Micronutrient Supplementation During Pregnancy: A Systematic Review and Individual Participant Data Meta-analysis. Adv Nutr. 2025 Jul;16(7):100455. doi: 10.1016/j.advnut.2025.100455. Epub 2025 May 30.
PubMed 40451462Berti C, Gaffey MF, Bhutta ZA, Cetin I. Multiple-micronutrient supplementation: Evidence from large-scale prenatal programmes on coverage, compliance and impact. Matern Child Nutr. 2018 Dec;14 Suppl 5(Suppl 5):e12531. doi: 10.1111/mcn.12531. Epub 2017 Dec 22.
PubMed 29271119Black J. Field trials of health interventions: a toolbox. Aust N Z J Public Health. 2017;41(4):452.
Offorha BC, Walters SJ, Jacques RM. Analysing cluster randomised controlled trials using GLMM, GEE1, GEE2, and QIF: results from four case studies. BMC Med Res Methodol. 2023 Dec 13;23(1):293. doi: 10.1186/s12874-023-02107-z.
PubMed 38093221Billot L, Copas A, Leyrat C, Forbes A, Turner EL. How should a cluster randomized trial be analyzed? J Epidemiol Popul Health. 2024 Feb;72(1):202196. doi: 10.1016/j.jeph.2024.202196. Epub 2024 Feb 10.
PubMed 38477477Kerr J, Rosenberg D, Millstein RA, Bolling K, Crist K, Takemoto M, Godbole S, Moran K, Natarajan L, Castro-Sweet C, Buchner D. Cluster randomized controlled trial of a multilevel physical activity intervention for older adults. Int J Behav Nutr Phys Act. 2018 Apr 2;15(1):32. doi: 10.1186/s12966-018-0658-4.
PubMed 29609594Toropova A, Bjorklund C, Bergstrom G, Elinder LS, Stigmar K, Wahlin C, Jensen I, Kwak L. Effectiveness of a multifaceted implementation strategy for improving adherence to the guideline for prevention of mental ill-health among school personnel in Sweden: a cluster randomized trial. Implement Sci. 2022 Mar 12;17(1):23. doi: 10.1186/s13012-022-01196-6.
PubMed 35279176Ingersoll KS, Cohen J. The impact of medication regimen factors on adherence to chronic treatment: a review of literature. J Behav Med. 2008 Jun;31(3):213-24. doi: 10.1007/s10865-007-9147-y. Epub 2008 Jan 19.
PubMed 18202907Mishra M, Parida D, Murmu J, Singh D, Rehman T, Kshatri JS, Pati S. Effectiveness of mHealth Interventions for Monitoring Antenatal Care among Pregnant Women in Low- and Middle-Income Countries: A Systematic Review and Meta-Analysis. Healthcare (Basel). 2023 Sep 27;11(19):2635. doi: 10.3390/healthcare11192635.
PubMed 37830672Mamo TT, Ashenafi E, Gube AA, Bekele T. Adherence to prenatal iron-folic acid supplementation and associated factors among pregnant women attending antenatal care services in Dilla town, South Ethiopia. Med Access Point Care. 2021 Apr 26;5:23992026211008805. doi: 10.1177/23992026211008805. eCollection 2021 Jan-Dec.
PubMed 36204490Yismaw AE, Tulu HB, Kassie FY, Araya BM. Iron-folic acid adherence and associated factors among pregnant women attending antenatal care at Metema District, Northwest Ethiopia. Front Public Health. 2022 Nov 18;10:978084. doi: 10.3389/fpubh.2022.978084. eCollection 2022.
PubMed 36466514
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial in Lombok: Assessing Factors Influencing Acceptance and Adherence to Multiple Micronutrient Supplementation (MMS) Using Digital Tools
- ClinicalTrials.gov ID
- NCT07555093
- Acronym / sponsor ID
- SMART-MMS / 090/UN18.F8/ETIK/2026
- Keywords
- MMS, Pregnancy, Digitalization, adherence, Antenatal Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,012 participants (estimated)
- Lead sponsor
- Summit Institute for Development, IndonesiaUniversity, hospital or other
- Collaborators
- Children's Investment Fund Foundation, Sight and Life Foundation
- Study start
- 13 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does a digitally supported intervention increase adherence to MMS compared to standard care?
- Does the type of MMS packaging (bottle vs. blister) affect adherence?
- 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:
- 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
Approximately 10,012 pregnant women will be randomly assigned to one of these four groups using a 2×2 factorial design.
Participants will:
- Receive MMS through either bottle or blister packaging
- Receive either standard care or a digital health intervention (such as reminders or digital support tools)
- Attend routine antenatal care services
- 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.
Detailed description
This study is a nested (two-stage) cluster-randomized controlled trial conducted in Lombok Island, designed to evaluate strategies to improve adherence to Multiple Micronutrient Supplementation (MMS) among pregnant women, as well as to assess the feasibility of integrating calcium supplementation into the MMS program within routine health systems.
The first stage of the study consists of a cluster randomized trial at the puskesmas (primary healthcare center) level. Puskesmas are randomized into four intervention arms to evaluate the effectiveness of different delivery approaches for MMS, specifically comparing combinations of digital and non-digital strategies, as well as packaging formats. The digital intervention includes mobile-based tools such as WhatsApp reminders, chatbot-assisted education, call center support, and a gamified alert system to encourage adherence. Artificial intelligence-based approaches, including adherence monitoring and prediction models, will also be explored. The non-digital group receives standard antenatal and postnatal care services, including routine health promotion and printed educational materials.
The second stage involves a cluster randomized trial at the posyandu (community health post) level within selected puskesmas. This stage evaluates the addition of calcium supplementation to MMS compared with MMS alone. Additional pregnant women will be enrolled outside the main MMS cohort and distributed across study arms. This component aims to assess the feasibility, acceptability, and operational considerations of co-administering calcium alongside MMS within the existing health system.
To support implementation across both study components, several operational and digital systems will be applied. Each supplement package will be labeled with a unique QR code to enable real-time tracking of supplement distribution and consumption through KoboToolbox. A Dynamic Worker Support (DWS) system will be implemented to assist Community Health Promoters in automated scheduling, task management, and field activity optimization.
Sample Size and Statistical Considerations
The sample size has been calculated based on the primary outcome of MMS adherence, accounting for clustering effects at both puskesmas and posyandu levels. Approximately 10,012 pregnant women will be enrolled in Stage 1 across 60 puskesmas clusters. In Stage 2, approximately 900 additional participants will be recruited to evaluate calcium co-supplementation. The sample size is designed to ensure adequate statistical power to detect meaningful differences between study groups.
A comprehensive quality assurance framework will be implemented to ensure data integrity, accuracy, and consistency across all study sites. Electronic data capture systems (KoboToolbox) will incorporate built-in validation rules, including range checks, consistency checks, and logical constraints across related variables. In addition, data validation will be strengthened through a double data entry process, whereby selected records are entered independently by two data entry personnel and discrepancies are identified and resolved through predefined verification procedures.
Routine centralized data monitoring will be conducted to assess data completeness, timeliness, and internal consistency. In addition, quality assurance (QA) activities will be implemented to assess field staff performance through direct verification. This includes periodic visits by QA staff to pregnant women to validate home visit activities conducted by field workers. QA may also be conducted through HealthComm by contacting participants to confirm services received and ensure consistency with reported data. These procedures aim to ensure adherence to study protocols, verify implementation fidelity, and maintain overall data quality.
A standardized data management system will be implemented, including a comprehensive data dictionary that defines all study variables, formats, permissible values, coding structures, and data sources. Where applicable, standardized coding approaches will be applied to ensure consistency.
All study procedures will be guided by Standard Operating Procedures (SOPs) and a detailed field manual to ensure standardized implementation across sites. The field manual provides step-by-step operational guidance for field staff, including participant recruitment, informed consent procedures, home visit protocols, supplement distribution, digital system utilization, and data collection processes.
It also outlines procedures for data management, adverse event reporting, and communication workflows between field teams and supervisors. Field staff, including Community Health Promoters, will receive structured training and ongoing supervision based on the field manual to ensure consistent, accurate, and high-quality implementation throughout the study.
Data quality checks during data collection will aim to minimize missingness. During analysis, appropriate statistical techniques, such as multiple imputation or sensitivity analyses, will be applied as specified in the statistical analysis plan.
All analyses will follow the intention-to-treat principle. Primary analyses will assess adherence to MMS across intervention arms using mixed-effects regression models to account for cluster randomization and potential confounders. The factorial design allows estimation of the independent and interaction effects of digital intervention and packaging type.
Secondary analyses will examine factors influencing adherence, maternal and neonatal outcomes, and the impact of calcium co-supplementation. Depending on the nature of the outcome variables, appropriate generalized linear (mixed-effects) models will be employed. Binary outcomes will be analyzed using mixed-effects logistic regression models, continuous outcomes using linear mixed-effects models, and count or proportion outcomes using Poisson or binomial-based models with appropriate link functions. All models will account for clustering at the study design level and adjust for relevant covariates. Subgroup and sensitivity analyses will be conducted to assess the robustness and generalizability of the findings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Digital Care with Blister | Experimental | Dietary Supplement: Blister pack, Other: Digital careParticipant 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 |
| Standard Care with Bottle | Active comparator | Dietary Supplement: Bottle pack, Other: Standard CareParticipant 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. |
| Standard Care with Blister | Active comparator | Dietary Supplement: Blister pack, Other: Standard CareParticipant will receive standard ANC and PNC services, regular health promotion and printed material, MMS provided in blister packaging, no digital adherence support is provided. |
| Digital Care with Bottle | Experimental | Dietary Supplement: Bottle pack, Other: Digital careParticipant 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women up to 32 weeks
- Pregnant women stay in the site at least during the study period
Key exclusion criteria (5 listed)
- Lost to follow up
- Moving to another area
- Death
- Abortus
- Stillbirth
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bottle packBottle packaging of MMS | Dietary supplement | Digital Care with Bottle, Standard Care with Bottle |
| Blister packBlister packaging of MMS | Dietary supplement | Digital Care with Blister, Standard Care with Blister |
| Standard CareStandard ANC and PNC services, regular health promotion and printed material | Other | Standard Care with Blister, Standard Care with Bottle |
| Digital careIn 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 | Other | Digital Care with Blister, Digital Care with Bottle |
Primary outcome
MMS consumption Adherence
Time frame: Since enrolment until delivery (up to approximately 280 days of gestation), with monthly assessments
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.
26 secondary outcomes
Gestational Age at Birth
Time frame: Birth
Proportion of Preterm Birth
Time frame: Birth
Proportion of Very and Extremely Preterm Birth
Time frame: Birth
Proportion of Post-term Birth
Time frame: Birth
Proportion of Stillbirth
Time frame: Birth
Perinatal Mortality
Time frame: Within 28 weeks of gestation to 7 days of birth
Neonatal Mortality
Time frame: Within 28 days of birth
Early Neonatal Mortality
Time frame: Within 7 days of birth
Late Neonatal Mortality
Time frame: Between 7 and 28 days of birth
Birth Weight
Time frame: Within 1 hour of birth
Proportion Low Birth Weight (LBW)
Time frame: Within 24 hours of birth
Small for Gestational Age (SGA, 3rd Centile)
Time frame: Within 24 hours of birth
Large for Gestational Age (LGA, 90th Centile)
Time frame: Birth
Birth Length
Time frame: Birth
Short for Gestational Age (10th Centile)
Time frame: Birth
Short for Gestational Age (3rd Centile)
Time frame: Birth
Head Circumference
Time frame: Birth
Infant Sex
Time frame: Birth
Length-for-age z-score (LAZ)
Time frame: Within 28 days of birth
Weight-for-Length Z-score (WLZ)
Time frame: Within 28 days of birth
Weight-for-Age Z-score (WAZ)
Time frame: Within 28 days of birth
Stunting
Time frame: Within 28 days of birth
Wasting
Time frame: Within 28 days of birth
Underweight
Time frame: Within 28 days of birth
Cost effectiveness
Time frame: Through study completion, an average of 1 year from the start of enrolment to the end of all monitoring phase
Calcium adherence
Time frame: From 20 weeks until delivery (up to approximately 280 days of gestation), with monthly assessments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 40075311Battung SM, Groen H, van der Beek EM. Prenatal multiple micronutrient supplementation in the Parepare district, Indonesia; population characteristics and intake adherence. BMC Public Health. 2025 Mar 12;25(1):983. doi: 10.1186/s12889-025-22129-0.
- Background: PubMed 38197817Dwarkanath P, Muhihi A, Sudfeld CR, Wylie BJ, Wang M, Perumal N, Thomas T, Kinyogoli SM, Bakari M, Fernandez R, Raj JM, Swai NO, Buggi N, Shobha R, Sando MM, Duggan CP, Masanja HM, Kurpad AV, Pembe AB, Fawzi WW. Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy. N Engl J Med. 2024 Jan 11;390(2):143-153. doi: 10.1056/NEJMoa2307212.
- Background: PubMed 30696573Hofmeyr GJ, Betran AP, Singata-Madliki M, Cormick G, Munjanja SP, Fawcus S, Mose S, Hall D, Ciganda A, Seuc AH, Lawrie TA, Bergel E, Roberts JM, von Dadelszen P, Belizan JM; Calcium and Pre-eclampsia Study Group. Prepregnancy and early pregnancy calcium supplementation among women at high risk of pre-eclampsia: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2019 Jan 26;393(10169):330-339. doi: 10.1016/S0140-6736(18)31818-X.
- Background: PubMed 39376478Borrelli EP, Saad P, Barnes NE, Dumitru D, Lucaci JD. Improving Adherence and Reducing Health Care Costs Through Blister-Packaging: An Economic Model for a Commercially Insured Health Plan. Clinicoecon Outcomes Res. 2024 Oct 3;16:733-745. doi: 10.2147/CEOR.S480890. eCollection 2024.
- Background: PubMed 40451462Smith ER, Gomes F, Adu-Afarwuah S, Aguayo VM, El Arifeen S, Bhutta ZA, Caniglia EC, Christian P, Devakumar D, Dewey KG, Fawzi WW, Friis H, Gomo E, Guindo O, Hallamaa L, Isanaka S, Kaestel P, Lachat C, Maleta K, Moore SE, Oakley EM, Osrin D, Rahman A, Rana Z, Rizvi A, Roberfroid D, Shaikh S, Sonko B, Soofi SB, Subarkah I, Sunawang R, Wang D, West KP Jr, Wu LSF, Zagre N, Bourassa MW, Sudfeld CR. Contribution of Maternal Adherence to the Effect of Multiple Micronutrient Supplementation During Pregnancy: A Systematic Review and Individual Participant Data Meta-analysis. Adv Nutr. 2025 Jul;16(7):100455. doi: 10.1016/j.advnut.2025.100455. Epub 2025 May 30.
- Background: PubMed 29271119Berti C, Gaffey MF, Bhutta ZA, Cetin I. Multiple-micronutrient supplementation: Evidence from large-scale prenatal programmes on coverage, compliance and impact. Matern Child Nutr. 2018 Dec;14 Suppl 5(Suppl 5):e12531. doi: 10.1111/mcn.12531. Epub 2017 Dec 22.
- BackgroundBlack J. Field trials of health interventions: a toolbox. Aust N Z J Public Health. 2017;41(4):452.
- Background: PubMed 38093221Offorha BC, Walters SJ, Jacques RM. Analysing cluster randomised controlled trials using GLMM, GEE1, GEE2, and QIF: results from four case studies. BMC Med Res Methodol. 2023 Dec 13;23(1):293. doi: 10.1186/s12874-023-02107-z.
- Background: PubMed 38477477Billot L, Copas A, Leyrat C, Forbes A, Turner EL. How should a cluster randomized trial be analyzed? J Epidemiol Popul Health. 2024 Feb;72(1):202196. doi: 10.1016/j.jeph.2024.202196. Epub 2024 Feb 10.
- Background: PubMed 29609594Kerr J, Rosenberg D, Millstein RA, Bolling K, Crist K, Takemoto M, Godbole S, Moran K, Natarajan L, Castro-Sweet C, Buchner D. Cluster randomized controlled trial of a multilevel physical activity intervention for older adults. Int J Behav Nutr Phys Act. 2018 Apr 2;15(1):32. doi: 10.1186/s12966-018-0658-4.
- Background: PubMed 35279176Toropova A, Bjorklund C, Bergstrom G, Elinder LS, Stigmar K, Wahlin C, Jensen I, Kwak L. Effectiveness of a multifaceted implementation strategy for improving adherence to the guideline for prevention of mental ill-health among school personnel in Sweden: a cluster randomized trial. Implement Sci. 2022 Mar 12;17(1):23. doi: 10.1186/s13012-022-01196-6.
- Background: PubMed 18202907Ingersoll KS, Cohen J. The impact of medication regimen factors on adherence to chronic treatment: a review of literature. J Behav Med. 2008 Jun;31(3):213-24. doi: 10.1007/s10865-007-9147-y. Epub 2008 Jan 19.
- Individual participant dataSharing planned: Yes. Individual Participant Data (IPD) requests must be submitted to the Principal Investigator and/or the lead research organization for further assessment and approval. Any request should clearly outline the purpose of data use, involved collaborators, proposed analysis plan, and intended publications. We would also like to be involved in all stages of the process, including preparation, data analysis, manuscript writing, and publication. Please note that, in principle, patient/client data belong to the respective individuals. Therefore, data sharing requires appropriate informed consent, which has been addressed in the approved study protocol. SID, as the lead research institution, will oversee and manage this process.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bottle pack, Blister pack and Digital care in people with Pregnancy and Adherence, run by Summit Institute for Development, Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuni Dwi Setiyawati, MHID (+6285337006810, yuni.setiyawati@sid-indonesia.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMS consumption Adherence (time frame: Since enrolment until delivery (up to approximately 280 days of gestation), with monthly assessments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07555093, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.