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FACE-APPS-Based Approach for Improving Iron Deficiency Anaemia Indicators Among Female Adolescents at Marginalized Communities: A Randomized Control Trial

2026年6月3日 更新者:Mahmoud Ahmed Ahmed Ahmed Elsheikh、Cairo University

This study aims to evaluate the effect of the Face-to-face Assisted Counselling with Enhanced Application School-Based Approach (FACE-APPS-Based Approach) on anemia indicators among female adolescents.

The study is a prospective, randomized controlled trial. A total of 160 female adolescents with hemoglobin levels below 12.0 g/dL will be recruited from 7 secondary schools. Random assignment at the individual level, stratified by baseline anemia status, will be used to ensure balance. For participants in the intervention group, the intervention will be designed by an interdisciplinary team and administered over 4 months, comprising 8 face-to-face counseling sessions and 8 parallel mobile application modules. Control group participants will receive standard care (diagnosis and referral). The primary outcomes are the mean differences in hemoglobin and serum ferritin levels. Secondary outcomes are engagement among female adolescents (attendance at counseling sessions and completion of mobile application modules).

調査の概要

詳細な説明

Anemia remains a major global public health concern. It disproportionately affects vulnerable populations, particularly adolescent females. According to the World Health Organization (WHO), anemia affects a substantial proportion of the global population. Adolescent girls represent a high-risk group due to rapid growth, increased nutritional requirements, and the onset of menstruation. Globally, approximately 15% of adolescents are affected by anemia. Prevalence varies widely across regions, from less than 10% in high-income countries to over 40% in low- and middle-income settings.

Anemia during adolescence has significant consequences. Iron deficiency anemia (IDA) impairs cognitive development, academic performance, and physical capacity. It also increases the risk of infection and affects psychosocial health. For adolescent girls, untreated anemia raises long-term risks-especially in future pregnancies, such as maternal mortality, low birth weight, and adverse neonatal outcomes. Thus, anemia is both an immediate and intergenerational public health issue.

Research is especially needed in KSA, where anemia is a major public health concern for children, adolescents, and women. Studies report high rates of anemia among adolescent females, with estimates ranging from 35% to over 50% in some regions . Despite ongoing efforts, disparities endure, particularly in underserved communities with limited access to healthcare and nutrition.

Given these gaps, the present study seeks to evaluate the impact of a blended digital health literacy intervention on behavioral and biological indicators of IDA among female adolescents in marginalized communities. Through the integration of school-based delivery, collaboration with primary health care, and culturally tailored digital education, this research intends to generate robust evidence to inform scalable and sustainable anemia prevention strategies. The study addresses a critical gap in the literature by assessing the effectiveness of a comprehensive, theory-driven intervention in an under-researched, high-need population.

研究の種類

介入

入学 (推定)

160

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Mahmoud Ahmed Elsheikh, PhD
  • 電話番号:00201066309578
  • メールmr.mash87@cu.edu.eg

研究場所

    • Wadi Addawasir Governorate
      • Wadi Addawasir、Wadi Addawasir Governorate、サウジアラビア、11991
        • 募集
        • Administration of Education, Secondary Schools
        • コンタクト:

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

健康ボランティアの受け入れ

はい

説明

Inclusion Criteria:

  • Adolescent females aged 14-17 years
  • who are attending high school
  • who have haemoglobin levels <12 mg/dl and serum ferritin levels below 15 μg/L

Exclusion Criteria:

  • Adolescents have other causes of anemia, such as thalassemia and sickle cell anemia, and malaria will be excluded.
  • Adolescents with chronic diseases that affect iron metabolism (e.g., chronic kidney disease) or other severe illnesses or conditions that may interfere with active participation.
  • Pregnant females will be excluded (if included in the age group).
  • Adolescents with gastrointestinal ulcers, colon polyps, or cancers; celiac disease; Crohn's disease; or gastric bypass surgery.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的:Intervention group: FACE-APPS-Based approach

The intervention will be delivered over 8 counselling sessions with the adolescents at schools and 8 modules of a mobile application. Each counselling session lasts 60-90 minutes. The sessions will be conducted by a researcher and a trained nurse. The 8 modules of a mobile application were designed as a self-learning package. Each module takes 20 minutes of study followed by 10 minutes of 10 MCQs. A counselling session and a mobile application module will be experienced biweekly for 4 months. Additional support: reminders via app notifications, and peer group discussion via the application.

The educational content was structured to systematically address the core constructs of Pender's Health Promotion Model (HPM).

This research is based on Pender's Health Promotion Model (HPM). It provides a comprehensive framework for influencing health-promoting behaviors in adolescents by leveraging cognitive, behavioral, and environmental factors. Pender's HPM asserts that health behaviors are shaped not only by knowledge but also by individual characteristics, behavior-specific cognitions, emotions, and commitment to action. Together, these lead to health-promoting behaviors and positive health outcomes. The model includes key factors such as age, socioeconomic status, parental education, baseline nutritional status, menstrual history, and existing medical conditions. These characteristics shape adolescents' perceptions and willingness to change behavior.

The intervention will be delivered over 8 counselling sessions with the adolescents at schools and 8 modules of a mobile application. Each counselling session lasts 60-90 minutes. The sessions will be conducted by a researcher and a trained nurse.

介入なし:Control group: Standard care
Adolescents in the IG will receive standard care. They will receive routine medical insurance care.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Hemoglobin and Serum Ferritin
時間枠:T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
To determine the level of Hb in g/dL, The HemoCue®Hb photometer will be used. the level of hemoglobin and ferritin will be confirmed by laboratory tests.
T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).

二次結果の測定

結果測定
メジャーの説明
時間枠
Module completion rates and attendance at counselling sessions.
時間枠:T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
engagement among female adolescents (attendance at counseling sessions and completion of mobile application modules). number of attendances to sessions and number of completed modules.
T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
HPLS profile II: HPLS-II
時間枠:T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).

HPLS profile II: HPLS-II is an applicable tool for measuring and assessing health-promoting behaviors. This questionnaire was developed based on the spiritual health promotion model and consisting of 52 items in six domains: health responsibility (nine items), spiritual growth (nine items), physical activity (eight items), interpersonal relationships (nine items), nutrition (nine items), and stress management (eight items). A Likert-type scale was used to measure each behavior, with ranges of never (1), sometimes (2), frequently (3), and regularly (4). The total score of the HPLP II ranges from 52 to 208 and is calculated as the mean score of responses to all 52 HPLP items.

This questionnaire is scored on a 4-point Likert scale from "Never = 1" to "Routinely = 4", with an overall score ranging from 52 to 208. Alpha reliability coefficient of .922 for the total scale; subscale alphas ranged from .702 to .904. The overall scale of the Arabic validated version of the HPLP II reported

T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).

協力者と研究者

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出版物と役立つリンク

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一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年5月24日

一次修了 (推定)

2026年11月30日

研究の完了 (推定)

2026年11月30日

試験登録日

最初に提出

2026年6月3日

QC基準を満たした最初の提出物

2026年6月3日

最初の投稿 (実際)

2026年6月8日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月8日

QC基準を満たした最後の更新が送信されました

2026年6月3日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

The dataset will be published at the data repository platform. The repository platform will be decided later at the publishing stage.

IPD 共有時間枠

July 2026 to July 2027

IPD 共有アクセス基準

data will be publicly published.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

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