An interventional study of Bottle pack and Blister pack in Pregnancy and Adherence, sponsored by Summit Institute for Development, Indonesia. Recruiting at 1 site in Indonesia. Open to female participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Summit Institute for Development, Indonesia · Not applicable, Interventional, and Other
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:
Researchers will compare four groups to see if digital support and packaging type improve MMS adherence:
Approximately 10,012 pregnant women will be randomly assigned to one of these four groups using a 2×2 factorial design.
Participants will:
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.
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.
Summit Institute for Development, Indonesia is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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
Bottle packaging of MMS
Blister packaging of MMS
Standard ANC and PNC services, regular health promotion and printed material
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
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.
Time frame: Since enrolment until delivery (up to approximately 280 days of gestation), with monthly assessments
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.
Time frame: Birth
Proportion of Preterm Birth
Proportion of live births occurring at \<37 completed weeks of gestation.
Time frame: Birth
Proportion of Very and Extremely Preterm Birth
Proportion of pregnancies delivered before these gestational age: at \<34 weeks, \<32 weeks, and \<28
Time frame: Birth
Proportion of Post-term Birth
Proportion of live births occurring at \>42 completed weeks of gestation.
Time frame: 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.
Time frame: Birth
Perinatal Mortality
Stillbirth (≥28 weeks gestation) or death of a liveborn infant within 7 completed days of birth.
Time frame: Within 28 weeks of gestation to 7 days of birth
Neonatal Mortality
Death of a liveborn infant within 28 completed days of birth.
Time frame: Within 28 days of birth
Early Neonatal Mortality
Death within 7 completed days of birth.
Time frame: Within 7 days of birth
Late Neonatal Mortality
Death occurs after 7 days but within 28 days of birth.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Birth
Birth Length
Mean birth length (cm).
Time frame: 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.
Time frame: 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.
Time frame: Birth
Head Circumference
Mean head circumference at birth (cm).
Time frame: Birth
Infant Sex
Proportion of male and female live births.
Time frame: Birth
Length-for-age z-score (LAZ)
Mean length (cm)-for-age z-score (LAZ)
Time frame: Within 28 days of birth
Weight-for-Length Z-score (WLZ)
Mean weight (gram)-for-age z-score (WAZ)
Time frame: Within 28 days of birth
Weight-for-Age Z-score (WAZ)
Mean weight (gram)-for-length z-score (WLZ)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From 20 weeks until delivery (up to approximately 280 days of gestation), with monthly assessments
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Started Jun 2026 (actual). Primary completion is estimated for May 2027, 11 months after the start.
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Summit Institute for Development, Indonesia