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Iron Deficiency AnemiaNCT07633262

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

A study testing FACE-APPS-Based Approach in people with Iron Deficiency Anemia and Digital Health Literacy, run by Cairo University at 1 site in Saudi Arabia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 to 14 years, women onlyHealthy volunteers can take part
What is being tested?
FACE-APPS-Based Approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteSaudi Arabia
Study dates
24 May 2026to 30 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 14 years
  • Women only
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mahmoud Ahmed Elsheikh, PhD contact

00201066309578

mr.mash87@cu.edu.eg

Saudi Arabia1 site, 1 recruiting
  • Administration of Education, Secondary Schools

    Wadi Addawasir, Wadi Addawasir Governorate, 11991

    Amnah Fahad Eldowasri, Master degree, 00966501066212 ext. 6490, Amn.aldawasri@psau.edu.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: 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).

Read the 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.

Being tested
FACE-APPS-Based Approach
Keywords
blended intervention, health promotion, iron deficiency anemia, adolescent females, adolescent behavior, female adolescents, marginalized communities
Medical subject headings
Anemia, Iron-Deficiency, Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FACE-APPS-Based ApproachBehavioural

    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.

Study groups in NCT07633262
Study groupRoleWhat they receive
Intervention group: FACE-APPS-Based approachExperimentalThe 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).
Receives: Behavioral: FACE-APPS-Based Approach
Control group: Standard careNo interventionAdolescents in the IG will receive standard care. They will receive routine medical insurance care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin and Serum Ferritin

    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.

    Measured: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).

Secondary outcomes (2)
  1. Module completion rates and attendance at counselling sessions.

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

    Measured: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).

  2. HPLS profile II: HPLS-II

    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

    Measured: T0 baseline, T1 at 4 months after completion of intervention, and follow-up at 6 months to assess sustainability (T2).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start24 May 2026
  3. Primary completion30 Nov 2026 (estimated)
  4. Study completion30 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07633262
Sponsor's protocol ID
SCBR-706/2026
Status last verified
May 2026
First submitted
3 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The dataset will be published at the data repository platform. The repository platform will be decided later at the publishing stage.

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 23746772
  • 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.

    PubMed 35427520
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing FACE-APPS-Based Approach in people with Iron Deficiency Anemia and Digital Health Literacy, run by Cairo University at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mahmoud Ahmed Elsheikh, PhD (00201066309578, mr.mash87@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07633262, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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