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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06009575
Other study ID # US
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1, 2021
Est. completion date January 31, 2022

Study information

Verified date August 2023
Source Universitas Sriwijaya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date January 31, 2022
Est. primary completion date January 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 11 Years to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Iron Supplement Tablets
The intervention group received IST and local culture-based nutrition education

Locations

Country Name City State
Indonesia Anita Rahmiwati Palembang South Sumatera

Sponsors (2)

Lead Sponsor Collaborator
Universitas Sriwijaya Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 12 Weeks
Primary 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 16 Weeks
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