FACE-APPS-Based Approach for Improving Iron Deficiency Anaemia Indicators Among Female Adolescents at Marginalized Communities: A Randomized Control Trial
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mahmoud Ahmed Elsheikh, PhD
- Número de teléfono: 00201066309578
- Correo electrónico: mr.mash87@cu.edu.eg
Ubicaciones de estudio
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Wadi Addawasir Governorate
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Wadi Addawasir, Wadi Addawasir Governorate, Arabia Saudita, 11991
- Reclutamiento
- Administration of Education, Secondary Schools
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Contacto:
- Amnah Fahad Eldowasri, Master degree
- Número de teléfono: 6490 00966501066212
- Correo electrónico: Amn.aldawasri@psau.edu.sa
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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. |
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Sin intervención: Control group: Standard care
Adolescents in the IG will receive standard care.
They will receive routine medical insurance care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Hemoglobin and Serum Ferritin
Periodo de tiempo: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
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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.
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T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Module completion rates and attendance at counselling sessions.
Periodo de tiempo: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
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engagement among female adolescents (attendance at counseling sessions and completion of mobile application modules).
number of attendances to sessions and number of completed modules.
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T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
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HPLS profile II: HPLS-II
Periodo de tiempo: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).
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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).
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Pasricha SR, Tye-Din J, Muckenthaler MU, Swinkels DW. Iron deficiency. Lancet. 2021 Jan 16;397(10270):233-248. doi: 10.1016/S0140-6736(20)32594-0. Epub 2020 Dec 4.
- Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.
- 10. Zuair AA. Assessment of a school-based, nursing-lead program to combat iron deficiency anemia among Saudi female adolescents: a pilot exploratory study. Discover Public Health 2025 22:1. 2025 Feb 11;22(1):47-. doi:10.1186/s12982-025-00427-7
- 9. Hazavehei M, Mohammadebrahim, Adibinegar. THE ROLE OF HEALTH EDUCATION IN REDUCING IRON DEFICIENCY ANEMIA IN YOUTH GIRLS: A SYSTEMATIC REVIEW. 2016.
- Salam RA, Hooda M, Das JK, Arshad A, Lassi ZS, Middleton P, Bhutta ZA. Interventions to Improve Adolescent Nutrition: A Systematic Review and Meta-Analysis. J Adolesc Health. 2016 Oct;59(4S):S29-S39. doi: 10.1016/j.jadohealth.2016.06.022.
- Aguayo VM, Paintal K, Singh G. The Adolescent Girls' Anaemia Control Programme: a decade of programming experience to break the inter-generational cycle of malnutrition in India. Public Health Nutr. 2013 Sep;16(9):1667-76. doi: 10.1017/S1368980012005587. Epub 2013 Jan 24.
- 6. Kumar S, Nahlen B. Intergenerational persistence of health: Evidence from India. Econ Lett. 2023 Mar 1;224:111023. doi:10.1016/j.econlet.2023.111023
- Martin-Rodriguez A, Bustamante-Sanchez A, Martinez-Guardado I, Navarro-Jimenez E, Plata-SanJuan E, Tornero-Aguilera JF, Clemente-Suarez VJ. Infancy Dietary Patterns, Development, and Health: An Extensive Narrative Review. Children (Basel). 2022 Jul 18;9(7):1072. doi: 10.3390/children9071072.
- Stevens GA, Paciorek CJ, Flores-Urrutia MC, Borghi E, Namaste S, Wirth JP, Suchdev PS, Ezzati M, Rohner F, Flaxman SR, Rogers LM. National, regional, and global estimates of anaemia by severity in women and children for 2000-19: a pooled analysis of population-representative data. Lancet Glob Health. 2022 May;10(5):e627-e639. doi: 10.1016/S2214-109X(22)00084-5.
- 1. Anaemia in women and children [Internet]. [cited 2026 Mar 28]. Available from: https://www.who.int/data/gho/data/themes/topics/anaemia_in_women_and_children
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
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Palabras clave
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Otros números de identificación del estudio
- SCBR-706/2026
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
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Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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