Maternal and Neonatal OutcomesOMEGA-MOMNCT07863206
Omega-3 Egg Intervention and Nutrition Education in Pregnant Women
A study testing Omega-3 Enriched Eggs and nutrition education in people with Maternal and Neonatal Outcomes and Pregnancy, run by Institut Pertanian Bogor at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to evaluate the effect of omega-3 enriched egg supplementation combined with nutrition education in pregnant women with Chronic Energy Deficiency (CED). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Maternal and Neonatal Outcomes, Pregnancy, Malnutrition Pregnancy
- What is being tested?
- Omega-3 Enriched Eggs and nutrition education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 May 2026to 30 Dec 2026
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age of 20-24 weeks (based on last menstrual period [LMP] or ultrasound).
- Pregnant women with Chronic Energy Deficiency (CED), defined as Mid-Upper Arm Circumference (MUAC) < 23.5 cm.
- Aged 20-35 years.
- No known egg allergy.
- Egg consumption frequency of 0-1 time per day.
- Receiving Multiple Micronutrient Supplements (MMS).
Who cannot join
- Presence of chronic diseases or pregnancy complications (e.g., preeclampsia, gestational diabetes).
- Gravidity ≥ 4 (number of pregnancies ≥ 4).
- History of preterm delivery.
- Multiple pregnancy (e.g., twin pregnancy).
- Interpregnancy interval < 2 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Omega-3 Egg Intervention and Nutrition Education on Nutritional Status and Pregnancy Outcomes in Pregnant Women
The goal of this clinical trial is to evaluate the effect of omega-3 enriched egg supplementation combined with nutrition education in pregnant women with Chronic Energy Deficiency (CED).
The main questions it aims to answer are:
Read more
- Does omega-3 egg supplementation combined with nutrition education improve maternal nutritional status (nutrient intake, anthropometry, serum DHA, EPA, IL-6, serum albumin, ferritin, knowledge, and Health Belief Model constructs) in pregnant women with CED compared to nutrition education alone?
- Does this combined intervention improve pregnancy and neonatal outcomes (gestational age, preterm birth, postpartum hemorrhage, newborn anthropometry, and breast milk fatty acid profile) compared to nutrition education alone?
Researchers will compare the intervention group (receiving omega-3 enriched eggs and nutrition education) to a control group (receiving nutrition education only) to evaluate these effects.
Participants will:
- Attend structured nutrition education sessions (both groups)
- Consume daily omega-3 enriched eggs during the intervention period (intervention group only)Undergo baseline and follow-up assessments including blood sampling (DHA, EPA, IL-6, albumin, ferritin), anthropometric measurements, and dietary questionnaires
- Provide post-delivery and neonatal data, as well as breast milk samples after delivery for fatty acid profiling
- Being tested
- Omega-3 Enriched Eggs, nutrition education
- Keywords
- Omega-3 Fatty Acids, Nutrition Education, Fortified Eggs, Nutritional Status, Pregnancy Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Enriched EggsDietary supplement
Participants will be provided with 2 omega-3 enriched eggs per day to consume daily throughout the study intervention period.
nutrition educationBehavioural
Participants will attend structured nutrition education sessions focusing on the importance, sources, and benefits of omega-3 fatty acids during pregnancy for maternal and fetal health.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 Egg + Nutrition Education | Experimental | Participants in this group receive daily omega-3 enriched eggs combined with structured nutrition education sessions. Receives: Dietary Supplement: Omega-3 Enriched Eggs; Behavioral: nutrition education |
| Nutrition Education | Active comparator | Participants in this group receive standard nutrition education only, without omega-3 egg supplementation. Receives: Behavioral: nutrition education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Serum DHA Level (ug/mL)
Evaluated via maternal blood serum analysis to measure changes in docosahexaenoic acid (DHA) concentrations before and after intervention, using Gas Chromatography (GC).
Measured: Baseline (Day 0) and 10 weeks post-intervention
Newborn Birth Weight (gram)
Weight of the newborn measured using a calibrated digital infant scale within 24 hours of delivery.
Measured: At delivery (within 24 hours post-birth)
Maternal serum EPA level (ug/mL)
Changes of maternal serum EPA level before and after intervention, using Gas Chromatography (GC).
Measured: Baseline (Day 0) and 10 weeks post-intervention
Newborn Birth Length (cm)
Length of the newborn measured from the top of the head to the heel using a standardized infantometer within 24 hours of delivery.
Measured: At delivery (within 24 hours post-birth)
Newborn Head Circumference (cm)
Maximum occipitofrontal circumference of the newborn measured using a non-stretchable measuring tape within 24 hours of delivery.
Measured: at delivery (within 24 hours post-birth)
Secondary outcomes (5)
Maternal Serum Albumin Level (g/dL)
Concentration of albumin in maternal blood serum measured post-intervention or at delivery to evaluate maternal protein nutritional status.
Measured: Baseline (Day 0) and 10 weeks post-intervention
Gestational Age at Delivery
Recorded in completed weeks and days at the time of delivery, determined by early ultrasound examination or last menstrual period (LMP).
Unit of Measure: Weeks
Measured: At delivery
Incidence of Preterm Delivery
Proportion of live births occurring prior to 37 completed weeks of gestation.
Measured: At delivery
Breast Milk Docosahexaenoic Acid (DHA) Level
Concentration of DHA in breast milk samples collected post-partum, expressed as a percentage of total fatty acids, analyzed using gas chromatography.
Measured: At 7 to 14 day postpartum
Maternal Serum Ferritin Levels (ng/mL)
Concentration of ferritin in maternal blood serum measured post-intervention or at delivery to evaluate maternal iron storage levels.
Measured: Baseline (Day 0) and 10 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start13 May 2026
- Primary completion26 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal and Neonatal OutcomesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated into two parallel groups with a 1:1 ratio: 1) Intervention group receiving daily omega-3 enriched eggs alongside structured nutrition education, and 2) Control group receiving standard nutrition education alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pertanian Bogor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harna Harna, Institut Pertanian Bogor
- Investigators
- Harna Harna, Principal investigator, Institut Pertanian Bogor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863206
- Sponsor's protocol ID
- 438/UN2.F1/ETIK/PPM.00.02/2026
- Acronym
- OMEGA-MOM
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant confidentiality and privacy, as explicit consent for public data sharing was not obtained during the informed consent process.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Omega-3 Egg Intervention and Nutrition Education on Nutritional Status and Pregnancy Outcomes in Pregnant Women
- ClinicalTrials.gov ID
- NCT07863206
- Acronym / sponsor ID
- OMEGA-MOM / 438/UN2.F1/ETIK/PPM.00.02/2026
- Keywords
- Omega-3 Fatty Acids, Nutrition Education, Fortified Eggs, Nutritional Status, Pregnancy Outcomes
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Institut Pertanian BogorUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Oct 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 clinical trial is to evaluate the effect of omega-3 enriched egg supplementation combined with nutrition education in pregnant women with Chronic Energy Deficiency (CED).
The main questions it aims to answer are:
- Does omega-3 egg supplementation combined with nutrition education improve maternal nutritional status (nutrient intake, anthropometry, serum DHA, EPA, IL-6, serum albumin, ferritin, knowledge, and Health Belief Model constructs) in pregnant women with CED compared to nutrition education alone?
- Does this combined intervention improve pregnancy and neonatal outcomes (gestational age, preterm birth, postpartum hemorrhage, newborn anthropometry, and breast milk fatty acid profile) compared to nutrition education alone?
Researchers will compare the intervention group (receiving omega-3 enriched eggs and nutrition education) to a control group (receiving nutrition education only) to evaluate these effects.
Participants will:
- Attend structured nutrition education sessions (both groups)
- Consume daily omega-3 enriched eggs during the intervention period (intervention group only)Undergo baseline and follow-up assessments including blood sampling (DHA, EPA, IL-6, albumin, ferritin), anthropometric measurements, and dietary questionnaires
- Provide post-delivery and neonatal data, as well as breast milk samples after delivery for fatty acid profiling
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are allocated into two parallel groups with a 1:1 ratio: 1) Intervention group receiving daily omega-3 enriched eggs alongside structured nutrition education, and 2) Control group receiving standard nutrition education alone.
| Arm | Type | Receives |
|---|---|---|
| Omega-3 Egg + Nutrition Education | Experimental | Dietary Supplement: Omega-3 Enriched Eggs, Behavioral: nutrition educationParticipants in this group receive daily omega-3 enriched eggs combined with structured nutrition education sessions. |
| Nutrition Education | Active comparator | Behavioral: nutrition educationParticipants in this group receive standard nutrition education only, without omega-3 egg supplementation. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Gestational age of 20-24 weeks (based on last menstrual period [LMP] or ultrasound).
- Pregnant women with Chronic Energy Deficiency (CED), defined as Mid-Upper Arm Circumference (MUAC) < 23.5 cm.
- Aged 20-35 years.
- No known egg allergy.
- Egg consumption frequency of 0-1 time per day.
Key exclusion criteria (5 listed)
- Presence of chronic diseases or pregnancy complications (e.g., preeclampsia, gestational diabetes).
- Gravidity ≥ 4 (number of pregnancies ≥ 4).
- History of preterm delivery.
- Multiple pregnancy (e.g., twin pregnancy).
- Interpregnancy interval < 2 years.
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 |
|---|---|---|
| Omega-3 Enriched EggsParticipants will be provided with 2 omega-3 enriched eggs per day to consume daily throughout the study intervention period. | Dietary supplement | Omega-3 Egg + Nutrition Education |
| nutrition educationParticipants will attend structured nutrition education sessions focusing on the importance, sources, and benefits of omega-3 fatty acids during pregnancy for maternal and fetal health. | Behavioural | Nutrition Education, Omega-3 Egg + Nutrition Education |
Primary outcome
Maternal Serum DHA Level (ug/mL)
Time frame: Baseline (Day 0) and 10 weeks post-intervention
Evaluated via maternal blood serum analysis to measure changes in docosahexaenoic acid (DHA) concentrations before and after intervention, using Gas Chromatography (GC).
Newborn Birth Weight (gram)
Time frame: At delivery (within 24 hours post-birth)
Weight of the newborn measured using a calibrated digital infant scale within 24 hours of delivery.
Maternal serum EPA level (ug/mL)
Time frame: Baseline (Day 0) and 10 weeks post-intervention
Changes of maternal serum EPA level before and after intervention, using Gas Chromatography (GC).
Newborn Birth Length (cm)
Time frame: At delivery (within 24 hours post-birth)
Length of the newborn measured from the top of the head to the heel using a standardized infantometer within 24 hours of delivery.
Newborn Head Circumference (cm)
Time frame: at delivery (within 24 hours post-birth)
Maximum occipitofrontal circumference of the newborn measured using a non-stretchable measuring tape within 24 hours of delivery.
5 secondary outcomes
Maternal Serum Albumin Level (g/dL)
Time frame: Baseline (Day 0) and 10 weeks post-intervention
Gestational Age at Delivery
Time frame: At delivery
Incidence of Preterm Delivery
Time frame: At delivery
Breast Milk Docosahexaenoic Acid (DHA) Level
Time frame: At 7 to 14 day postpartum
Maternal Serum Ferritin Levels (ng/mL)
Time frame: Baseline (Day 0) and 10 weeks post-intervention
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 7 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant confidentiality and privacy, as explicit consent for public data sharing was not obtained during the informed consent 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. This study is not recruiting at the moment.
Harna Harna principal investigator
Institut Pertanian Bogor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Enriched Eggs and nutrition education in people with Maternal and Neonatal Outcomes and Pregnancy, run by Institut Pertanian Bogor 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 6 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 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?
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?
Maternal Serum DHA Level (ug/mL) (time frame: Baseline (Day 0) and 10 weeks post-intervention). The study lists 5 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 7 Oct 2026.