A School-Based Anti-Inflammatory Dietary Intervention With or Without a Physical Activity Programme to Support Reproductive Health in Adolescent Girls
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Mediterranean Diet Quality Index for Children and Adolescents (KIDMED) Score
研究概览
简要总结
This study will evaluate whether a 16-week anti-inflammatory dietary intervention, delivered alone or together with a physical activity programme, can improve diet quality and support reproductive health in girls aged 14-19 years. Approximately 100 participants will be recruited from two secondary schools in Poland. Participants at both schools will receive education and practical guidance on an anti-inflammatory diet based on Mediterranean dietary principles. Participants at one school will additionally take part in a supervised physical activity programme conducted twice weekly.
The primary outcome will be the change in diet quality assessed using the KIDMED index. Additional assessments will examine menstrual health, premenstrual symptoms, menstrual pain, physical activity, body composition, anthropometric measures, selected salivary biomarkers, and the oral microbiome. Assessments will be conducted before and after the intervention.
详细描述
This is a two-arm, parallel, school-based interventional study involving approximately 100 girls aged 14-19 years recruited from two secondary schools in the Greater Poland region. The intervention will last 16 weeks. Participants will not be individually randomized. Each participating school will implement one of the two intervention programmes; therefore, allocation will occur at the school level for organizational reasons.
Participants in the anti-inflammatory diet group (AIDiet) will take part in a dietary education programme based on Mediterranean dietary principles. The programme will include four practical and theoretical workshops addressing anti-inflammatory food choices and their potential relevance to reproductive health. Educational materials and tools for monitoring progress will also be available through a dedicated digital platform.
Participants in the combined intervention group (AIDiet/PAT) will receive the same dietary intervention and will additionally participate in a physical activity programme consisting of two supervised exercise sessions per week for 16 weeks. The sessions will be conducted by a physical education teacher or trainer and adapted to the participants' age and abilities.
The primary objective is to compare changes in diet quality, assessed using the KIDMED index, between the AIDiet and AIDiet/PAT groups. Secondary objectives include evaluating changes in menstrual cycle characteristics, menstrual pain, premenstrual symptoms, physical activity, anthropometric and body composition measures, selected salivary inflammatory, oxidative stress and hormonal biomarkers, and the composition and diversity of the oral microbiome.
Medical assessments, questionnaires, anthropometric and body composition measurements, and biological sample collection will be conducted before and after the intervention. The study does not include an untreated control group because all participants will receive health education intended to support reproductive health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 19 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female adolescents aged 14 to 19 years
- •Attendance at one of the participating secondary schools
- •Provision of written informed consent by the participant and, for participants below the age of legal consent, by a parent or legal guardian
- •Willingness to participate in the study assessments and the assigned 16-week intervention
排除标准
- •Presence of systemic or hereditary diseases Thyroid dysfunction, diabetes mellitus, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of a pituitary adenoma, or an androgen-secreting tumour.
- •Severe salivary gland dysfunction, including Sjögren syndrome
- •Chronic use of medications, hormonal therapy, antibiotic treatment, or regular use of dietary supplements with potential effects on hormonal, inflammatory, oxidative stress, or microbiome-related outcomes within the previous three months.
- •Regular alcohol consumption or tobacco smoking
- •Allergy to olive oil, nuts, legumes, spices, or herbs
- •Medical contraindications to physical exercise or participation in the training programme.
- •Participants with acute oral infections, gingival bleeding, or other oral conditions affecting the reliability of oral microbiome assessments may remain eligible for the other study assessments but will not be included in the relevant oral microbiome analyses.
研究组 & 干预措施
Anti-Inflammatory Diet (AIDiet)
Participants receive a 16-week anti-inflammatory dietary intervention based on Mediterranean dietary principles. The programme includes dietary education, practical workshops, dietary recommendations, and access to educational materials through a dedicated digital platform. No additional physical activity programme is provided as part of this study arm.
干预措施: Anti-Inflammatory Dietary Intervention (Behavioral)
Anti-Inflammatory Diet Plus Physical Activity and Training (AIDiet/PAT)
Participants receive a 16-week anti-inflammatory dietary intervention based on Mediterranean dietary principles and additionally participate in a physical activity programme consisting of two sessions per week. The physical activity programme is delivered by the study team in the school setting and adapted to the participants' age and abilities. Educational materials are also available through a dedicated digital platform.
干预措施: Anti-Inflammatory Dietary Intervention (Behavioral)
Anti-Inflammatory Diet Plus Physical Activity and Training (AIDiet/PAT)
Participants receive a 16-week anti-inflammatory dietary intervention based on Mediterranean dietary principles and additionally participate in a physical activity programme consisting of two sessions per week. The physical activity programme is delivered by the study team in the school setting and adapted to the participants' age and abilities. Educational materials are also available through a dedicated digital platform.
干预措施: Physical Activity and Training Programme (Behavioral)
结局指标
主要结局
Change in Mediterranean Diet Quality Index for Children and Adolescents (KIDMED) Score
时间窗: Baseline and immediately after the 16-week intervention
Diet quality will be assessed using the 16-item Mediterranean Diet Quality Index for Children and Adolescents (KIDMED). Positively scored items receive +1 point and negatively scored items receive -1 point, giving a total score ranging from -4 to 12. Higher scores indicate better adherence to a Mediterranean dietary pattern. Change from baseline to post-intervention will be compared between the study arms.
次要结局
- Change in Menstrual Pain Intensity Assessed Using a Visual Analogue Scale(Baseline and immediately after the 16-week intervention)
- Change in Premenstrual Symptom Severity Assessed Using the Premenstrual Symptoms Screening Tool(Baseline and immediately after the 16-week intervention)
- Change in Self-Reported Menstrual Cycle Regularity(Baseline and immediately after the 16-week intervention)
- Change in Body Mass Index(Baseline and immediately after the 16-week intervention)
- Change in Body Fat Percentage(Baseline and immediately after the 16-week intervention)
- Change in Fat-Free Mass(Baseline and immediately after the 16-week intervention)
- Change in Waist Circumference(Baseline and immediately after the 16-week intervention)
- Change in Systolic and Diastolic Blood Pressure(Baseline and immediately after the 16-week intervention)
- Change in Acne Severity Assessed Using the Investigator's Global Assessment(Baseline and immediately after the 16-week intervention)
- Change in Hirsutism Severity Assessed Using the Modified Ferriman-Gallwey Score(Baseline and immediately after the 16-week intervention)