Nutrient DeficiencyNCT06225791
Antenatal Multiple Micronutrient Supplementation (MMS) in Indonesia
A study testing MMS (90x2) + BCC or expanded BCC and MMS (180x1) + BCC or expanded BCC in people with Nutrient Deficiency, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Indonesia.
Trial summary
The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Indonesian national health system context to support improved maternal nutrition and birth outcomes. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Nutrient Deficiency
- What is being tested?
- MMS (90x2) + BCC or expanded BCC and MMS (180x1) + BCC or expanded BCC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,384 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Dec 2023to 17 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
- Enrolled in ANC 1 through government health facilities.
- Received MMS at ANC 1
- Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
- Consent provided to participate in the study.
Exclusion Criteria for 3,360 pregnant women (PW) enrolled from 8 high-intensity evaluation districts (sample group 1)
- PW with complicated pregnancy complications (e.g., thalassemia, hemochromatosis,)
- PW planning to move outside study district during study period.
Inclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
- Enrolled in ANC 1 through government health facilities.
- Received MMS at ANC 1
- Gestational age at ANC 1 ≤ 20 weeks (verified by health professionals)
- Consent provided to participate in qualitative component of study.
- Received MMS for at least 3 months.
- Attended > 2 ANC visits.
- < 4 weeks post-partum
Exclusion Criteria for 72 PW / recently delivered women participating in in-depth interviews (IDI) only (sample group 2)
- Enrolled in Sample 1
- Women who are more than 4 weeks postpartum.
Inclusion Criteria for 180 healthcare providers participating in focus group discussions (FGDs) (sample group 3)
- Government health workers who provide ANC services (e.g., midwives, general practitioners, and nutritionists)
- Government health facility management staff (e.g., Head of Puskesmas Community Health Clinic, Coordinating Midwife, Head of Pharmacy)
- Willing to give consent to participate in the FGD.
Exclusion Criteria for 180 healthcare providers participating in FGDs (sample group 3) • Healthcare Providers who have already participated in a FGD will not be eligible to participate in another FGD
Inclusion Criteria for 76 government decision-makers participating in FGD or IDI (sample group 4)
- District-, provincial-, or national-level decision-makers working in nutrition, maternal, newborn and child health, or pharmaceutical roles associated with the antenatal care system in Indonesia.
- Willing to give consent to participate in the FGD or IDI.
Exclusion Criteria for 76 government decision-makers participating in FGD or IDI (sample group 4)
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation Research to Accelerate Multiple Micronutrient Supplementation During Pregnancy in Indonesia
The objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Indonesian national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:
- Examine different MMS delivery strategies (i.e., packaging strategies and behavior change communication (BCC) strategies) in relation to MMS adherence.
- Assess acceptability, feasibility, fidelity, and coverage of MMS program implementation within antenatal care services (ANC)
Read the detailed description
The study will utilize qualitative and quantitative methods to:
- Test different MMS delivery strategies (bottle count [90 vs. 180 tablets] and communication strategies [BCC vs. expanded BCC vs. MMS orientation only]) for enhancing supplementation consumption - measured as coverage and adherence.
- Assess acceptability, feasibility, and fidelity of MMS program implementation within antenatal care services (ANC)
More specifically, the investigators will implement and evaluate different MMS packaging (90 count bottle vs 180-count bottle) strategies and behavior change communication (BCC) strategies. The 3 BCC approaches are further described below.
- BCC, BCC without Interpersonal Communication (IPC) strategy is a briefer more basic approach that hopes to improve health care providers knowledge about MMS and the providers ability to communicate with pregnant women. This approach will be rolled out by training one district-level facilitator in each district to become a trainer who will be responsible for training health providers in the corresponding study sub-districts.
- Expanded BCC ('BCC with Interpersonal Communication [IPC]') needs more intensive training of master trainers to train health care providers and focuses more on the counselling skills portion. The BCC without IPC is more feasible to implement within the existing system, the investigators anticipate that the BCC with IPC achieve better behavior change results.
- MMS Orientation: Women in the control group will receive the existing standard of counselling care. The providers will not be given any sort of training on counselling. Due to the fact that MMS is a new product that the providers will be providing pregnant women, all health care providers will receive a standard MMS orientation so providers are comfortable with the new supplement.
The study will be conducted in 25 districts representing the western, central, and eastern regions of Indonesia, Indonesia's socio-cultural diversity, and varying capacity of ANC systems across districts. After selection, the 25 districts were divided to receive high-intensity (8 districts), moderate-intensity (5 districts), or low-intensity (12 districts) evaluation activities with those exposed to high-intensity evaluation efforts having comprehensive individual-level data collected by study employed data collectors while the low-and moderate-intensity district data collection efforts are being done within the context of the existing health system.
- High intensity evaluation areas (8 districts) Evaluation of MMS acceptability, coverage, adherence, feasibility, and fidelity will include data collection from health professionals and pregnant women by study data collectors, and by ANC monitoring activities.
- Moderate intensity evaluation areas (5 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, data collectors will collect MMS acceptability, feasibility, and fidelity data within 2 of those 5 districts.
- Low intensity evaluation area (12 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, a household coverage survey will be administered in a subset of districts (n=6) post-intervention to examine MMS acceptability, adherence, coverage, and implementation feasibility and fidelity. The coverage survey will be designed after 6 months of implementation and will be submitted as a separate application to the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, and a separate entry into Clinicaltrials.gov.
Within the 8 high-intensity districts and 5 moderate-intensity districts that are the subject of this Clinicaltrials.gov submission, the study will utilize a three-arm cluster randomized design (with sub-district health center as the unit of randomization).
- Conditions
- Nutrient Deficiency
- Being tested
- MMS (90x2) + BCC or expanded BCC, MMS (180x1) + BCC or expanded BCC
- Keywords
- multiple micronutrient supplementation (MMS), pregnancy, behavior change, packaging, antenatal care (ANC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMS (90x2) + BCC or expanded BCCBehavioural
Provision of 90-count bottles x 2, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC)
MMS (180x1) + BCC or expanded BCCBehavioural
Provision of 180-count bottles x 1, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC)
| Study group | Role | What they receive |
|---|---|---|
| Standard MMS delivery with two 90-count bottles | No intervention | Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with standard MMS delivery strategy (MMS orientation only). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation). |
| Enhanced MMS delivery with two 90-count bottles | Active comparator | Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation). Receives: Behavioral: MMS (90x2) + BCC or expanded BCC |
| Enhanced MMS delivery with one 180-count bottle | Active comparator | Pregnant women are provided with one 180-count bottle of MMS along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 with MMS orientation with expanded BCC). (1 sub-district with each of the 13 districts with high- or moderate-intensity evaluation). Receives: Behavioral: MMS (180x1) + BCC or expanded BCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMS Adherence (amount)
The number of MMS tablets (from a total possible 180 tablets) a pregnant woman consumes (sample group 1).
Measured: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
MMS Adherence (frequency)
The frequency of which MMS tablets are consumed by a pregnant woman. (sample group 1)
Measured: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
Secondary outcomes (3)
MMS Acceptability among Pregnant Women
The proportion of pregnant women (sample group 1 and 2) who agree with domain-specific statements which reflect different aspects of MMS acceptability (MMS packaging, MMS physical properties, MMS side effects, and MMS counseling using The Theoretical Framework of Acceptability uses a 5-point Likert scale where 5 is "strongly agree" and 1 is "strongly disagree". Score range 5-35, a higher score reflects higher acceptability.
Measured: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
MMS Acceptability among Health Providers assessed by focus group discussions
Healthcare provider acceptability of MMS across multiple domains (e.g., feasibility of delivering counseling and packaging, time burden) (sample group 3). Measured via focus group discussions at two time points during the study (middle and end).
Measured: 6 months, 12 months
Fidelity of providing MMS among Health Providers as assessed by focus group discussions
Administration of an observation checklist (sample group 3),measured via focus group discussions at two time points during the study (middle and end)
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start25 Dec 2023
- Primary completion31 Jan 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient DeficiencyStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- MMS will be implemented across 13 districts in Indonesia. In each of the 8 high-intensity evaluation districts and 5 moderate-intensity evaluation districts, 3 study arms/sub-districts have been purposively selected (total n = 24 sub-districts). * Arm/sub-district 1: Provision of 90-count bottles x 2, with standard MMS delivery strategies and MMS orientation * Arm/sub-district 2: Provision of 90-count bottles x 2, with enhanced MMS deliveries strategy (3 with MMS orientation with BCC; 5 with MMS orientation with expanded BCC) * Arm/sub-district 3: Provision of 180-count bottles x 1, with enhanced MMS delivery strategy (3 with MMS orientation with BCC; 5 with MMS orientation with expanded BCC)
- Masking
- None (open label)
- Enrolment
- 5,384 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia, Hasanuddin University, Universitas Airlangga, Vitamin Angels
- Responsible party
- Sponsor
- Investigators
- Endang Achadi, PhD, Principal investigator, Universitas IndonesiaKristin Hurley, PhD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225791
- Sponsor's protocol ID
- IRB00016428 / MOD00004017
- Status last verified
- Jun 2025
- First submitted
- 19 Dec 2023
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Research to Accelerate Multiple Micronutrient Supplementation During Pregnancy in Indonesia
- ClinicalTrials.gov ID
- NCT06225791
- Acronym / sponsor ID
- IRB00016428 / MOD00004017
- Conditions
- Nutrient Deficiency
- Keywords
- multiple micronutrient supplementation (MMS), pregnancy, behavior change, packaging, antenatal care (ANC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,384 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Universitas Indonesia, Hasanuddin University, Universitas Airlangga, Vitamin Angels
- Study start
- 25 Dec 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 26 Jan 2024 (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 objective of this research is to understand how antenatal multiple micronutrient supplements (MMS) can be effectively implemented and scaled within the Indonesian national health system context to support improved maternal nutrition and birth outcomes. Formative research has been conducted to design the implementation strategies that will be tested in this second phase of the study. The objectives are to:
- Examine different MMS delivery strategies (i.e., packaging strategies and behavior change communication (BCC) strategies) in relation to MMS adherence.
- Assess acceptability, feasibility, fidelity, and coverage of MMS program implementation within antenatal care services (ANC)
Detailed description
The study will utilize qualitative and quantitative methods to:
- Test different MMS delivery strategies (bottle count [90 vs. 180 tablets] and communication strategies [BCC vs. expanded BCC vs. MMS orientation only]) for enhancing supplementation consumption - measured as coverage and adherence.
- Assess acceptability, feasibility, and fidelity of MMS program implementation within antenatal care services (ANC)
More specifically, the investigators will implement and evaluate different MMS packaging (90 count bottle vs 180-count bottle) strategies and behavior change communication (BCC) strategies. The 3 BCC approaches are further described below.
- BCC, BCC without Interpersonal Communication (IPC) strategy is a briefer more basic approach that hopes to improve health care providers knowledge about MMS and the providers ability to communicate with pregnant women. This approach will be rolled out by training one district-level facilitator in each district to become a trainer who will be responsible for training health providers in the corresponding study sub-districts.
- Expanded BCC ('BCC with Interpersonal Communication [IPC]') needs more intensive training of master trainers to train health care providers and focuses more on the counselling skills portion. The BCC without IPC is more feasible to implement within the existing system, the investigators anticipate that the BCC with IPC achieve better behavior change results.
- MMS Orientation: Women in the control group will receive the existing standard of counselling care. The providers will not be given any sort of training on counselling. Due to the fact that MMS is a new product that the providers will be providing pregnant women, all health care providers will receive a standard MMS orientation so providers are comfortable with the new supplement.
The study will be conducted in 25 districts representing the western, central, and eastern regions of Indonesia, Indonesia's socio-cultural diversity, and varying capacity of ANC systems across districts. After selection, the 25 districts were divided to receive high-intensity (8 districts), moderate-intensity (5 districts), or low-intensity (12 districts) evaluation activities with those exposed to high-intensity evaluation efforts having comprehensive individual-level data collected by study employed data collectors while the low-and moderate-intensity district data collection efforts are being done within the context of the existing health system.
- High intensity evaluation areas (8 districts) Evaluation of MMS acceptability, coverage, adherence, feasibility, and fidelity will include data collection from health professionals and pregnant women by study data collectors, and by ANC monitoring activities.
- Moderate intensity evaluation areas (5 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, data collectors will collect MMS acceptability, feasibility, and fidelity data within 2 of those 5 districts.
- Low intensity evaluation area (12 districts) Evaluation of ANC records with aggregate coverage and adherence numbers will be shared with investigators. In addition, a household coverage survey will be administered in a subset of districts (n=6) post-intervention to examine MMS acceptability, adherence, coverage, and implementation feasibility and fidelity. The coverage survey will be designed after 6 months of implementation and will be submitted as a separate application to the Johns Hopkins Bloomberg School of Public Health Institutional Review Board, and a separate entry into Clinicaltrials.gov.
Within the 8 high-intensity districts and 5 moderate-intensity districts that are the subject of this Clinicaltrials.gov submission, the study will utilize a three-arm cluster randomized design (with sub-district health center as the unit of randomization).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- MMS will be implemented across 13 districts in Indonesia. In each of the 8 high-intensity evaluation districts and 5 moderate-intensity evaluation districts, 3 study arms/sub-districts have been purposively selected (total n = 24 sub-districts). * Arm/sub-district 1: Provision of 90-count bottles x 2, with standard MMS delivery strategies and MMS orientation * Arm/sub-district 2: Provision of 90-count bottles x 2, with enhanced MMS deliveries strategy (3 with MMS orientation with BCC; 5 with MMS orientation with expanded BCC) * Arm/sub-district 3: Provision of 180-count bottles x 1, with enhanced MMS delivery strategy (3 with MMS orientation with BCC; 5 with MMS orientation with expanded BCC)
| Arm | Type | Receives |
|---|---|---|
| Standard MMS delivery with two 90-count bottles | No intervention | –Pregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with standard MMS delivery strategy (MMS orientation only). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation). |
| Enhanced MMS delivery with two 90-count bottles | Active comparator | Behavioral: MMS (90x2) + BCC or expanded BCCPregnant women are provided with two 90-count bottles of MMS at two different time points during pregnancy, along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC). (1 sub-district within each of the 13 districts with high- or moderate-intensity evaluation). |
| Enhanced MMS delivery with one 180-count bottle | Active comparator | Behavioral: MMS (180x1) + BCC or expanded BCCPregnant women are provided with one 180-count bottle of MMS along with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 with MMS orientation with expanded BCC). (1 sub-district with each of the 13 districts with high- or moderate-intensity evaluation). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| MMS (90x2) + BCC or expanded BCCProvision of 90-count bottles x 2, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC) | Behavioural | Enhanced MMS delivery with two 90-count bottles |
| MMS (180x1) + BCC or expanded BCCProvision of 180-count bottles x 1, with enhanced MMS delivery strategy (5 districts with MMS orientation with BCC; 8 districts with MMS orientation with expanded BCC) | Behavioural | Enhanced MMS delivery with one 180-count bottle |
Primary outcome
MMS Adherence (amount)
Time frame: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
The number of MMS tablets (from a total possible 180 tablets) a pregnant woman consumes (sample group 1).
MMS Adherence (frequency)
Time frame: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
The frequency of which MMS tablets are consumed by a pregnant woman. (sample group 1)
3 secondary outcomes
MMS Acceptability among Pregnant Women
Time frame: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks
MMS Acceptability among Health Providers assessed by focus group discussions
Time frame: 6 months, 12 months
Fidelity of providing MMS among Health Providers as assessed by focus group discussions
Time frame: 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Endang Achadi, PhD principal investigator
Universitas Indonesia
Kristin Hurley, PhD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMS (90x2) + BCC or expanded BCC and MMS (180x1) + BCC or expanded BCC in people with Nutrient Deficiency, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMS Adherence (amount) (time frame: Post-enrollment up to 3 months, Post-pregnancy up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2025.