AnemiaPhase 3NCT06009575
Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study
A Phase 3 study testing Iron Supplement Tablets in people with Anemia and Iron Deficiency Anemia, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to test the impact of a local culture-based nutritional education intervention on IST consumption compliance among female adolescents in the Ogan Komering Ilir Regency. Read more about this study
- Who is it for?
- Ages 11 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron Deficiency Anemia
- What is being tested?
- Iron Supplement Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2021to 31 Jan 2022
- Phase
- Phase 3
- 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 11 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- public schools have received the IST program from the government, and the distance between schools is at least 10 kilometers
- students enrolled in grade 11, age range 15-17 years, menstruating, owning a smartphone, having an Instagram account, and obtaining parental approval to participate in this study
Who cannot join
- schools that are currently the object of another study and are difficult to reach (remote areas)
- students who have a BMI value≤ -3 SD and do not watch complete educational videos for the sample in the intervention group
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to test the impact of a local culture-based nutritional education intervention on IST consumption compliance among female adolescents in the Ogan Komering Ilir Regency. The main questions it aims to answer are:
a To identify information for the development of a local culture-based nutrition education model and to build a ready-to-implement local culture-based nutrition education model.
Read more
- To evaluate the implementation of the Anemia Prevention and Control Program among female adolescents in Ogan Komering Ilir Regency.
- To test the impact of the local culture-based nutrition education model on the improvement of knowledge, attitude, and IST consumption compliance among female adolescents.
Participants will received IST and local culture-based nutrition education. Researchers will compare control group received IST as the Ministry of Health's program for the prevention of anemia with a subsidy for providing IST
- Conditions
- Anemia, Iron Deficiency Anemia
- Being tested
- Iron Supplement Tablets
- Keywords
- anemia, Iron Supplement Tablets
- Medical subject headings
- Anemia, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron Supplement TabletsDietary supplement
The intervention group received IST and local culture-based nutrition education
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Dietary Supplement: Iron Supplement Tablets |
| control group | Active comparator | Not described Receives: Dietary Supplement: Iron Supplement Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Educational Intervention
The local culture to be used was based on the results of a qualitative study conducted prior to the intervention, where Kelakar Betok is the local culture preferred by female adolescents, used as a means of nutrition education. Subsequently, the social media used in nutrition education publicity is Instagram. Nutrition education is provided in the form of educational videos based on local culture broadcasted through the Instagram account @remaja.bebasanemia.
Measured: 12 Weeks
Iron Supplement Tablet (IST) Administration
The IST used as an intervention consists of IST containing 60 mg FeSO4 and 400 mcg of folic acid, which is a government program. The program policy for administering IST to female adolescents is carried out once a week in the year, which was given in a blanket approach. This supplementation was carried out at educational institutions. The schools that receive iron tablets are Junior High Schools and Senior High Schools
Measured: 16 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jul 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Collaborators
- Universitas Indonesia
- Responsible party
- Principal investigator, Anita Rahmiwati, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009575
- Sponsor's protocol ID
- US
- Status last verified
- Aug 2023
- First submitted
- 19 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol Statistical Analysis Plan (SAP)
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Culture-Based Nutrition Education Intervention on Iron Supplement Tablets (IST) Consumption Compliance in Female Adolescents at Ogan Komering Ilir Regency: A Quasi-Experimental Protocol Study
- ClinicalTrials.gov ID
- NCT06009575
- Acronym / sponsor ID
- US
- Conditions
- Anemia, Iron Deficiency Anemia
- Keywords
- anemia, Iron Supplement Tablets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Collaborators
- Universitas Indonesia
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 24 Aug 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.
The goal of this clinical trial is to test the impact of a local culture-based nutritional education intervention on IST consumption compliance among female adolescents in the Ogan Komering Ilir Regency. The main questions it aims to answer are:
a To identify information for the development of a local culture-based nutrition education model and to build a ready-to-implement local culture-based nutrition education model.
- To evaluate the implementation of the Anemia Prevention and Control Program among female adolescents in Ogan Komering Ilir Regency.
- To test the impact of the local culture-based nutrition education model on the improvement of knowledge, attitude, and IST consumption compliance among female adolescents.
Participants will received IST and local culture-based nutrition education. Researchers will compare control group received IST as the Ministry of Health's program for the prevention of anemia with a subsidy for providing IST
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Dietary Supplement: Iron Supplement Tablets |
| control group | Active comparator | Dietary Supplement: Iron Supplement Tablets |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- public schools have received the IST program from the government, and the distance between schools is at least 10 kilometers
- students enrolled in grade 11, age range 15-17 years, menstruating, owning a smartphone, having an Instagram account, and obtaining parental approval to participate in this study
Key exclusion criteria (2 listed)
- schools that are currently the object of another study and are difficult to reach (remote areas)
- students who have a BMI value≤ -3 SD and do not watch complete educational videos for the sample in the intervention group
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 |
|---|---|---|
| Iron Supplement TabletsThe intervention group received IST and local culture-based nutrition education | Dietary supplement | control group, intervention group |
Primary outcome
Educational Intervention
Time frame: 12 Weeks
The local culture to be used was based on the results of a qualitative study conducted prior to the intervention, where Kelakar Betok is the local culture preferred by female adolescents, used as a means of nutrition education. Subsequently, the social media used in nutrition education publicity is Instagram. Nutrition education is provided in the form of educational videos based on local culture broadcasted through the Instagram account @remaja.bebasanemia.
Iron Supplement Tablet (IST) Administration
Time frame: 16 Weeks
The IST used as an intervention consists of IST containing 60 mg FeSO4 and 400 mcg of folic acid, which is a government program. The program policy for administering IST to female adolescents is carried out once a week in the year, which was given in a blanket approach. This supplementation was carried out at educational institutions. The schools that receive iron tablets are Junior High Schools and Senior High Schools
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 24 Aug 2023.
- Individual participant dataSharing planned: Undecided. Study Protocol Statistical Analysis Plan (SAP)
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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 Phase 3 study testing Iron Supplement Tablets in people with Anemia and Iron Deficiency Anemia, run by Universitas Sriwijaya 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 2 inclusion and 2 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 24 Aug 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Educational Intervention (time frame: 12 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 24 Aug 2023.