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

August 19, 2023 updated by: Anita Rahmiwati, Universitas Sriwijaya

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • South Sumatera
      • Palembang, South Sumatera, Indonesia, 30139
        • Anita Rahmiwati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
Dietary supplement: Iron Supplement Tablets
The intervention group received IST and local culture-based nutrition education
Experimental: intervention group
Dietary supplement: Iron Supplement Tablets
The intervention group received IST and local culture-based nutrition education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 Weeks
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
16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sriwijaya

Collaborators

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

August 19, 2023

First Submitted That Met QC Criteria

August 19, 2023

First Posted (Actual)

August 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 19, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study Protocol Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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