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

3 giugno 2026 aggiornato da: 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).

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

160

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Mahmoud Ahmed Elsheikh, PhD
  • Numero di telefono: 00201066309578
  • Email: mr.mash87@cu.edu.eg

Luoghi di studio

    • Wadi Addawasir Governorate
      • Wadi Addawasir, Wadi Addawasir Governorate, Arabia Saudita, 11991
        • Reclutamento
        • Administration of Education, Secondary Schools
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Nessun intervento: Control group: Standard care
Adolescents in the IG will receive standard care. They will receive routine medical insurance care.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hemoglobin and Serum Ferritin
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Module completion rates and attendance at counselling sessions.
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 maggio 2026

Completamento primario (Stimato)

30 novembre 2026

Completamento dello studio (Stimato)

30 novembre 2026

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

8 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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

Periodo di condivisione IPD

July 2026 to July 2027

Criteri di accesso alla condivisione IPD

data will be publicly published.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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