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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 de junho de 2026 atualizado por: 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).

Visão geral do estudo

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

160

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Mahmoud Ahmed Elsheikh, PhD
  • Número de telefone: 00201066309578
  • E-mail: mr.mash87@cu.edu.eg

Locais de estudo

    • Wadi Addawasir Governorate
      • Wadi Addawasir, Wadi Addawasir Governorate, Arábia Saudita, 11991
        • Recrutamento
        • Administration of Education, Secondary Schools
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Hemoglobin and Serum Ferritin
Prazo: 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).

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Module completion rates and attendance at counselling sessions.
Prazo: 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
Prazo: 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).

Colaboradores e Investigadores

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Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de maio de 2026

Conclusão Primária (Estimado)

30 de novembro de 2026

Conclusão do estudo (Estimado)

30 de novembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

3 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de junho de 2026

Primeira postagem (Real)

8 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

July 2026 to July 2027

Critérios de acesso de compartilhamento IPD

data will be publicly published.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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