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

NCT06009575 | Completed Phase 3 DMC

• 1 other identifier: US
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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

Conditions

Anemia; Iron Deficiency Anemia

Keywords

anemia; Iron Supplement Tablets

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

intervention group

EXPERIMENTAL

Dietary Supplement: Iron Supplement Tablets

control group

ACTIVE COMPARATOR

Dietary Supplement: Iron Supplement Tablets

Interventions

Iron Supplement Tablets DIETARY_SUPPLEMENT

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

control group; intervention group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Sriwijaya: lead
• Indonesia University: collaborator

Study Sites (1)

Anita Rahmiwati

Palembang, South Sumatera, 30139, Indonesia

Location

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

Iron-Dextran Complex

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 24, 2023
• Study Start: July 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Locations

ID (1)