Two Randomized Trials of Low-Dose Calcium Supplementation in Pregnancy.
Pratibha Dwarkanath, Alfa Muhihi, Christopher R Sudfeld...
https://pubmed.ncbi.nlm.nih.gov/38197817/Actively Recruiting
Led by Summit Institute for Development, Indonesia · Updated on 2026-07-01
10012
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating whether a digital health intervention can improve adherence to Multiple Micronutrient Supplementation MMS among pregnant women on Lombok Island. This study also explores how individual traits, socio-economic factors, maternal health, and antenatal care influence MMS adherence. Additionally, the study investigates the impact of different MMS packaging types and the addition of calcium supplementation on adherence. Participants are randomly assigned to one of four groups combining standard care or digital intervention with MMS provided in either bottle or blister packaging. The digital intervention includes tools such as WhatsApp reminders, chatbot education, call center support, gamified alerts, and AI-based adherence monitoring. In a secondary stage, an additional group receives calcium supplementation alongside MMS to assess its effect on adherence. MMS distribution is tracked using QR codes and digital monitoring systems. Participants attend routine antenatal care and are followed from enrollment through delivery and up to 42 days postpartum. Data collection includes monthly adherence assessments, birth outcomes such as gestational age and birth weight, and infant growth measurements. Quality assurance measures ensure data accuracy. The study aims to understand adherence patterns, maternal and neonatal outcomes, and the operational feasibility of integrating these interventions into local health systems.
CONDITIONS
A Study of Multiple Micronutrient Supplementation (MMS) to Increase Adherence With Digital Technology
Y
Yuni Dwi Setiyawati, MHID
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Summit Institute for Development, Indonesia
Lead Sponsor
Children's Investment Fund Foundation
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From enrollment until delivery (up to approximately 280 days of gestation)
Participants receive Multiple Micronutrient Supplements in either bottle or blister packaging, with or without digital health support. They will attend routine antenatal care and use digital tools like reminders and QR code tracking to support supplement adherence.
Monthly visits and assessments
Duration - Up to 42 days after childbirth
Participants are monitored at delivery and during the postnatal period up to 42 days after birth to assess maternal and neonatal outcomes.
Regular postnatal visits
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
OTHER
Number of Arms
4
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https://pubmed.ncbi.nlm.nih.gov/29493896/Summit Institute for Development, Indonesia
Lead Sponsor
Children's Investment Fund Foundation
Collaborating Sponsor