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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

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ClinicalTrials.gov Identifier: NCT06009575
Recruitment Status : Completed
First Posted : August 24, 2023
Last Update Posted : August 24, 2023
Sponsor:
Collaborator:
Indonesia University
Information provided by (Responsible Party):
Anita Rahmiwati, Universitas Sriwijaya

Study Description
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Brief 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. 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.

b. To evaluate the implementation of the Anemia Prevention and Control Program among female adolescents in Ogan Komering Ilir Regency.

c. 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


Condition or disease Intervention/treatment Phase
Anemia Iron Deficiency Anemia Dietary Supplement: Iron Supplement Tablets Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : July 1, 2021
Actual Primary Completion Date : January 31, 2022
Actual Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: intervention group Dietary Supplement: Iron Supplement Tablets
The intervention group received IST and local culture-based nutrition education
Active Comparator: control group Dietary Supplement: Iron Supplement Tablets
The intervention group received IST and local culture-based nutrition education


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06009575


Locations
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Indonesia
Anita Rahmiwati
Palembang, South Sumatera, Indonesia, 30139
Sponsors and Collaborators
Universitas Sriwijaya
Indonesia University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Anita Rahmiwati, Dr, Universitas Sriwijaya
ClinicalTrials.gov Identifier: NCT06009575    
Other Study ID Numbers: US
First Posted: August 24, 2023    Key Record Dates
Last Update Posted: August 24, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study Protocol Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anita Rahmiwati, Universitas Sriwijaya:
anemia
Iron Supplement Tablets
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Iron Deficiencies
Hematologic Diseases
 Iron Metabolism Disorders
Metabolic Diseases
Anemia, Hypochromic