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

NCT07633262 | Recruiting DMC

• 1 other identifier: SCBR-706/2026
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Iron Deficiency Anemia; Health Promotion Model (HPM); Digital Health Literacy

Keywords

blended intervention; health promotion; iron deficiency anemia; adolescent females; adolescent behavior; female adolescents; marginalized communities

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (2)

• Module completion rates and attendance at counselling sessions.

  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

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

Study Arms (2)

Intervention group: FACE-APPS-Based approach

EXPERIMENTAL

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).

Behavioral: FACE-APPS-Based Approach

Control group: Standard care

NO INTERVENTION

Adolescents in the IG will receive standard care. They will receive routine medical insurance care.

Interventions

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.

Intervention group: FACE-APPS-Based approach

Eligibility Criteria

• Age: 14 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Ain Shams University: collaborator
• Prince Sattam Bin Abdulaziz University: collaborator
• Northern Border University: collaborator

Study Sites (1)

Administration of Education, Secondary Schools

Wadi Addawasir, Wadi Addawasir Governorate, 11991, Saudi Arabia

RECRUITING

Related Publications (10)

• 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

  RESULT

• 9. Hazavehei M, Mohammadebrahim, Adibinegar. THE ROLE OF HEALTH EDUCATION IN REDUCING IRON DEFICIENCY ANEMIA IN YOUTH GIRLS: A SYSTEMATIC REVIEW. 2016.

  RESULT

• 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 RESULT

• 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 RESULT

• 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

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 35427520 RESULT

• 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

  RESULT

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Adolescent Behavior

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Central Study Contacts

Mahmoud Ahmed Elsheikh, PhD

CONTACT

00201066309578; mr.mash87@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 8, 2026
• Study Start: May 24, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: July 2026 to July 2027
• Access Criteria: data will be publicly published.

Locations

SA (1)