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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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Indonesia

Study Type

Interventional

Intervention

Iron Supplement Tablets

About this trial

This is an interventional prevention trial for Anemia focused on measuring anemia, Iron Supplement Tablets

Eligibility Criteria

11 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Anita Rahmiwati

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

intervention group

control group

Arm Description

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

Full Information

NCT ID

NCT06009575

First Posted

August 19, 2023

Last Updated

August 19, 2023

Sponsor

Universitas Sriwijaya

Collaborators

Indonesia University

1. Study Identification

Unique Protocol Identification Number

NCT06009575

Brief 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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2021 (Actual)

Primary Completion Date

January 31, 2022 (Actual)

Study Completion Date

January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universitas Sriwijaya

Collaborators

Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Iron Deficiency Anemia

Keywords

anemia, Iron Supplement Tablets

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Experimental

Arm Title

control group

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Iron Supplement Tablets

Intervention Description

The intervention group received IST and local culture-based nutrition education

Primary Outcome Measure Information:

Title

Educational Intervention

Description

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.

Time Frame

12 Weeks

Title

Iron Supplement Tablet (IST) Administration

Description

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

Time Frame

16 Weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

11 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Anita Rahmiwati

City

Palembang

State/Province

South Sumatera

ZIP/Postal Code

30139

Country

Indonesia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Study Protocol Statistical Analysis Plan (SAP)

Anemia, Iron Deficiency Anemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial