About this 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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 design
Parallel
Treatments tested in this trial
FACE-APPS-Based Approach
BehavioralThis 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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
Locations
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Sponsors and contacts
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Cairo University
Lead sponsor
Prince Sattam Bin Abdulaziz University
Collaborator
Ain Shams University
Collaborator
Northern Border University
Collaborator