Health EducationNCT06138262
Preconception Nutrition Education Intervention for Prospective Brides
A study testing Health promotion of education pre-conception nutritional preparation in people with Health Education, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This research focuses on the importance of preconception health care. In this research, an intervention was carried out providing health education regarding preconception nutritional preparation. Research methods used is a Quasi Experiment with the Non Equivalent Control Group method. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Health Education
- What is being tested?
- Health promotion of education pre-conception nutritional preparation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 30 Oct 2023
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged 20 to 35 years old
- Have no history of disease that weakens anemia and nutritional intake
- Examination maximum 3 months before the wedding
- Prospective bridal couples do not delay the pregnancy program
Who cannot join
- Not complete premarital reproductive health examination
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Puskesmas / Government First Level Health Facilities
Depok, West Java
About this study
Official title: Effectiveness of Preconception Nutrition Education for Prospective Brides to Prevent Anemia and Chronic Energy Deficiency During Pregnancy.
This research focuses on the importance of preconception health care. In this research, an intervention was carried out providing health education regarding preconception nutritional preparation. Research methods used is a Quasi Experiment with the Non Equivalent Control Group method. Example used in this research were 100 prospective brides and grooms in Indonesia. The intervention group will be provided with education through a preconception nutrition education module and the brides health card, and the control group was given education using the brides health leaflet.
- Conditions
- Health Education
- Being tested
- Health promotion of education pre-conception nutritional preparation
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health promotion of education pre-conception nutritional preparationOther
Providing education on pregnancy nutritional preparation during the preconception period 3 months before the wedding
| Study group | Role | What they receive |
|---|---|---|
| health promotion education about preconception nutrition | Experimental | Not described Receives: Other: Health promotion of education pre-conception nutritional preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin Level
Measurement of hemoglobin levels by taking a blood sample is then analyzed by laboratory staff at the health center (health facility service where the examination is carried out) then the results are written on the laboratory check results in units of measurement gr/dL with a normal value of at least 12 gr/dL with the subject being an adult woman and pregnant women in the 1st trimester..
Measured: one day
Body Mass Index
Body mass index is measured by measuring body weight (kilograms) divided by height (meters) squared with units of measurement kg/m2 with subjects measured by adult women and pregnant women in the 1st trimester, with a minimum normal BMI value of 18.5 kg/m2.
Measured: one day
Midupper Arm Circumference (MUAC)
MUAC is measured in adults women using a flexible meter line tape laid at the midpoint between the acromion and olecranon processes on the shoulder blade and the ulna, respectively, of the arm, with a normal value of at least 23.5 cm.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jan 2023
- Primary completion30 May 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health EducationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- In this study there were 2 groups, namely the group that was given intervention and the group that was not given intervention / control group. The intervention group will be provided with education through a preconception nutrition education module and the leaflet, and the control group was given education using the leaflet.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ratna Wulandari, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138262
- Sponsor's protocol ID
- 2106769774
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Preconception Nutrition Education for Prospective Brides to Prevent Anemia and Chronic Energy Deficiency During Pregnancy.
- ClinicalTrials.gov ID
- NCT06138262
- Acronym / sponsor ID
- 2106769774
- Conditions
- Health Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 18 Nov 2023 (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.
This research focuses on the importance of preconception health care. In this research, an intervention was carried out providing health education regarding preconception nutritional preparation. Research methods used is a Quasi Experiment with the Non Equivalent Control Group method. Example used in this research were 100 prospective brides and grooms in Indonesia. The intervention group will be provided with education through a preconception nutrition education module and the brides health card, and the control group was given education using the brides health leaflet.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- In this study there were 2 groups, namely the group that was given intervention and the group that was not given intervention / control group. The intervention group will be provided with education through a preconception nutrition education module and the leaflet, and the control group was given education using the leaflet.
| Arm | Type | Receives |
|---|---|---|
| health promotion education about preconception nutrition | Experimental | Other: Health promotion of education pre-conception nutritional preparation |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged 20 to 35 years old
- Have no history of disease that weakens anemia and nutritional intake
- Examination maximum 3 months before the wedding
- Prospective bridal couples do not delay the pregnancy program
Key exclusion criteria (1 listed)
- Not complete premarital reproductive health examination
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 |
|---|---|---|
| Health promotion of education pre-conception nutritional preparationProviding education on pregnancy nutritional preparation during the preconception period 3 months before the wedding | Other | health promotion education about preconception nutrition |
Primary outcome
Haemoglobin Level
Time frame: one day
Measurement of hemoglobin levels by taking a blood sample is then analyzed by laboratory staff at the health center (health facility service where the examination is carried out) then the results are written on the laboratory check results in units of measurement gr/dL with a normal value of at least 12 gr/dL with the subject being an adult woman and pregnant women in the 1st trimester..
Body Mass Index
Time frame: one day
Body mass index is measured by measuring body weight (kilograms) divided by height (meters) squared with units of measurement kg/m2 with subjects measured by adult women and pregnant women in the 1st trimester, with a minimum normal BMI value of 18.5 kg/m2.
Midupper Arm Circumference (MUAC)
Time frame: one day
MUAC is measured in adults women using a flexible meter line tape laid at the midpoint between the acromion and olecranon processes on the shoulder blade and the ulna, respectively, of the arm, with a normal value of at least 23.5 cm.
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 18 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health promotion of education pre-conception nutritional preparation in people with Health Education, run by Universitas 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 18 Nov 2023. 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?
Haemoglobin Level (time frame: one day). The study lists 3 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 18 Nov 2023.