FACE-APPS-Based Approach for Improving Iron Deficiency Anaemia Indicators Among Female Adolescents at Marginalized Communities

Official title

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

Overview

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).

Detailed description

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.

Interventions

• Behavioral FACE-APPS-Based Approach
  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 in

Primary outcome measures

• Hemoglobin and Serum Ferritin [Time frame: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).]

Secondary outcome measures (2)

• Module completion rates and attendance at counselling sessions. [Time frame: 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 [Time frame: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

Saudi Arabia · 1 center

• Administration of Education, Secondary Schools — Wadi Addawasir

Publications

• 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. PMID 27664593
• 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. PMID 23343620
• 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. PMID 35884056
• 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. PMID 33285139
• 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. PMID 23746772

Identifiers

NCT: NCT07633262 · SCBR-706/2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗