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IRCT20200114046123N1 IRCT 2020-01-23 Shahid Beheshti University of Medical Sciences Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary disease Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary syndrome 2020-09-22 anticipated 120 Complete https://irct.ir/trial/45065 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The sampling method is random cluster sampling in the educational districts of Tehran. At first Tehran are divided into five educational districts (East, West, North, South and Center). The areas in the five districts are written separately on paper and were drawn randomly. Then again, in each cluster, the girls' secondary schools are written separately on a single paper and randomly drawn. In the draw, the first school name in each district is placed in the intervention group respectively; the second school name in that district is placed in the control group (two schools in each district). N/A poly cystic ovarian syndrome. Intervention 1: "Intervention group:" Face-to-face teaching polycystic ovary syndrome adolescents are conducted in eight 45-minute sessions of lecture, question and answer provided by the researcher. The adolescent health promotion package was designed based on the Nice Clinical Guidelines Model. Based on this model, the package was designed after searching the guides, books, sexual health packages of various countries as well as available articles. Then, Delphi method was used to validate the sexual health package by specialists and experts in different cities of Iran. Designed in two parts for the adolescent and adolescent lifestyle educator, the package is designed to include the most important aspects of adolescent health during education years. Intervention 2: "Control group: " The control group receive only routine care and receive no intervention and training packages. Routine care includes blood pressure control, weight measurement, blood biomarkers and ultrasound measurement. Yes - There is a plan to make this available What will be shared: one report include: introduction, methods, results and discussion When: 12 months after published manuscript To whom: Academic researchers are allowed access to data Conditions: Citing the source Where to obtain: Correspondence with responsible author by email How to obtain: The application letter should include the name of the applicant, the use and the scientific title of the research project or article in question. Comments:
public Somayeh Abdolahian
School of Nursing & Midwifery, Niayesh and Valiasr intersection
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2512 abdolahian.s@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Fatemeh Nahidi
School of Nursing & Midwifery, intersection of Valiasr and Niayesh
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8820 2512 nahidifateme@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Written parental and student agreement Girls ages 14 to 18 who are single and without sexual relation At least 2 years passed from the juvenile menarche According to ASRM criteria, 2 items of PCOS symptoms were diagnosed Be healthy in terms of all diseases including liver, kidney, thyroid, heart and skeletal diseases Have not taken any female hormone or metformin medication for at least three months before entering the study Have no smoking at least three months before the intervention Do not use drugs or alcohol Not have severe mental illness (which requires medication) Do not exercise professionally or attend school sports team Do not follow a specific diet 14 years 18 years Female Adolescents who failed to perform 1/3 of the recommended physical activities per month for any reason Adolescents who for any reason failed to attend 1/3 of the classes held at the school. Adolescents who have not completed any form of physical activity and diet assessment for at least one month for any reason. Adolescents who affected by a specific illness or need to take a particular drug after entering the plan. Adolescents who they or their parents are reluctant to continue in the project for any reason. E28.2 Polycystic ovarian syndrome Lifestyle Lifestyle "Intervention group:" Face-to-face teaching polycystic ovary syndrome adolescents are conducted in eight 45-minute sessions of lecture, question and answer provided by the researcher. The adolescent health promotion package was designed based on the Nice Clinical Guidelines Model. Based on this model, the package was designed after searching the guides, books, sexual health packages of various countries as well as available articles. Then, Delphi method was used to validate the sexual health package by specialists and experts in different cities of Iran. Designed in two parts for the adolescent and adolescent lifestyle educator, the package is designed to include the most important aspects of adolescent health during education years. "Control group: " The control group receive only routine care and receive no intervention and training packages. Routine care includes blood pressure control, weight measurement, blood biomarkers and ultrasound measurement. Life style modification in adolescent with poly cystic ovarian syndrome. Timepoint: before intervention, 6 and 12 after intervention. Method of measurement: diet and physical activity questionnaire. Menstrual cycleregularity,. Timepoint: Before intervention and 6, 12 months after intervention. Method of measurement: Menstrual cycles are <21 or more than 35 days or have <8 cycles per year will be considered irregular. Hirsutism status. Timepoint: Before intervention and 6, 12 months after intervention. Method of measurement: The Ferriman–Gallwey scale will be used for Hirsutism status; a score of 1–4 is given for nine areas of the body. A total score <9 is considered normal, a score of 9–15 indicates mild Hirsutism, and a score >15 indicates moderate or severe Hirsutism. Anthropometric index. Timepoint: Before intervention and 6, 12 months after intervention. Method of measurement: weight,height, waist, and hip circumstance. Blood bio markers. Timepoint: before intervention and after 12 months. Method of measurement: Blood test. Sonography Items. Timepoint: before intervention and after 12 months. Method of measurement: Transabdominal Sonography. Shahid Beheshti University of Medical Sciences Approved 2018-07-02 Ethics committee of Shahid Beheshti University of Medical Sciences 7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)