FACE-APPS-Based Approach for Improving Iron Deficiency Anaemia Indicators Among Female Adolescents at Marginalized Communities: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 14 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control group: Standard care
Adolescents in the IG will receive standard care. They will receive routine medical insurance care.
Intervention group: FACE-APPS-Based approach
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).
干预措施: FACE-APPS-Based Approach (Behavioral)
研究者
Mahmoud Ahmed Ahmed Ahmed Elsheikh
Assistant Professor
Cairo University