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NCT Number: NCT07633262

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

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).

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Key information

Age range

14 year–14 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Administration of Education, Secondary Schools

Wadi Addawasir, Wadi Addawasir Governorate, 11991, Saudi Arabia

Location status: Recruiting

Location contact

Amnah Fahad Eldowasri, Master degree

CONTACT

[email protected]

00966501066212 ext. 6490

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FACE-APPS-Based Approach

Behavioral

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.

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. 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).

    engagement among female adolescents (attendance at counseling sessions and completion of mobile application modules). number of attendances to sessions and number of completed modules.

  2. 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).

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Ahmed Elsheikh, PhD

CONTACT

[email protected]

00201066309578

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Ain Shams University
  • Northern Border University
  • Prince Sattam Bin Abdulaziz University

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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