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General information
100
120
100120
2020-01-21, 1398/11/01
2020-09-22, 1399/07/01
2020-0109-2122 00:00:00
2021-01-20, 1399/11/01
2021-09-23, 1400/07/01
2021-0109-2023 00:00:00
empty
Due to the conditions of school closures and changes in the implementation of this plan in Tehran girls' high schools, it is necessary to express it in this section as well.
Due to the conditions of school closures and changes in the implementation of this plan in Tehran girls' high schools, it is necessary to express it in this section as well.
empty
به خاطر شرایط تعطیلی مدارس و تاخیر در انجام این طرح در دبیرستاهای دخترانه تهران تغییراتی لحاظ شد که لازم است در این قسمت هم بیان شود
به خاطر شرایط تعطیلی مدارس و تاخیر در انجام این طرح در دبیرستاهای دخترانه تهران تغییراتی لحاظ شد که لازم است در این قسمت هم بیان شود
Primary outcomes
#1
lifestyle kid screen, diet and physical activity questionnaire
diet and physical activity questionnaire
lifestyle kid screen, diet and physical activity questionnaire
پرسشنامه سبک زندگی نوجوان، تغذیه، فعالیت فیزیکی
پرسشنامه تغذیه، فعالیت فیزیکی
پرسشنامه سبک زندگی نوجوان، تغذیه، فعالیت فیزیکی
#2
empty
menstrual cycleregularity,
menstrual cycleregularity,
empty
نظم سیکل قاعدگی
نظم سیکل قاعدگی
empty
Before intervention and 6, 12 months after intervention
Before intervention and 6, 12 months after intervention
empty
قبل از مداخله و 6 و 12 ماه بعد از مداخه
قبل از مداخله و 6 و 12 ماه بعد از مداخه
empty
Menstrual cycles are <21 or more than 35 days or have <8 cycles per year will be considered irregular
Menstrual cycles are <21 or more than 35 days or have <8 cycles per year will be considered irregular
empty
سیکلهای قاعدگی کمتر از 21 روز یا بیشتر از 35 روز یا در کل کمتر از 8 سیکل در سال به عنوان سیکل قاعدگی نامنظم در نظر گرفته می شود
سیکلهای قاعدگی کمتر از 21 روز یا بیشتر از 35 روز یا در کل کمتر از 8 سیکل در سال به عنوان سیکل قاعدگی نامنظم در نظر گرفته می شود
#3
empty
Hirsutism status
Hirsutism status
empty
وضعیت پرمویی مردانه
وضعیت پرمویی مردانه
empty
Before intervention and 6, 12 months after intervention
Before intervention and 6, 12 months after intervention
empty
قبل از مداخله و 6 و 12 ماه بعد از مداخله
قبل از مداخله و 6 و 12 ماه بعد از مداخله
empty
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
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
empty
ابزار فریدمن گالوی که 9 منطقه از بدن را مورد بررسی قرار می دهد و به هر منطقه نمره 1 تا 4 از نظر شدت رویش مو داده می شود. مجموع نمرات پایین 9 به عنوان سالم در نظر گرفته می شود و نمرات بین 9 تا 15 پرمویی مردانه خفیف و نمره بالای 15 به عنوان متوسط تا شدید در نظر گرفته می شود
ابزار فریدمن گالوی که 9 منطقه از بدن را مورد بررسی قرار می دهد و به هر منطقه نمره 1 تا 4 از نظر شدت رویش مو داده می شود. مجموع نمرات پایین 9 به عنوان سالم در نظر گرفته می شود و نمرات بین 9 تا 15 پرمویی مردانه خفیف و نمره بالای 15 به عنوان متوسط تا شدید در نظر گرفته می شود
#4
empty
Anthropometric index
Anthropometric index
empty
شاخصهای تن سنجی
شاخصهای تن سنجی
empty
Before intervention and 6, 12 months after intervention
Before intervention and 6, 12 months after intervention
empty
قبل از مداخله- 6 و 12 ماه بعد از مداخله
قبل از مداخله- 6 و 12 ماه بعد از مداخله
empty
weight,height, waist, and hip circumstance
weight,height, waist, and hip circumstance
empty
اندازه گیری قد و وزن و دور کمر و دور باسن
اندازه گیری قد و وزن و دور کمر و دور باسن
Intervention groups
#1
"Intervention group:" Face-to-face teaching to polycystic ovary syndrome adolescents is conducted in eight 60-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 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 group:" Face-to-face teaching to polycystic ovary syndrome adolescents isare conducted in eight 6045-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.
"گروه مداخله:" آموزش بصورت چهره به چهره به نوجوانان مبتلا به سندرم تخمدان پلی کیستیک در هشت جلسه ی 60 دقیقه ای در طول دوران تحصیل بصورت سخنرانی، پرسش و پاسخ که توسط پژوهشگر تهیه شده است، انجام میشود. بسته ارتقا سلامت نوجوان براساس الگوی دستورالعمل های بالینی نایس طراحی شده است. براساس این الگو، پس از جستجو در گایدلاین ها، کتب، بسته های سلامت جنسی کشورهای مختلف و نیز مقالات موجود، بسته طراحی گردید. سپس با استفاده از نظرات افراد متخصص و صاحب نظر شهرهای مختلف ایران با روش دلفی، بسته سلامت جنسی اعتباریابی گردید. این بسته، (در دو قسمت برای آموزش دهنده سبک زندگی نوجوان و نوجوان مبتلا) به گونه ای طراحی شده است که مطالب آموزشی آن در طول دوران تحصیل مهمترین ابعاد سلامت نوجوان را شامل شده است.
"گروه مداخله:" آموزش بصورت چهره به چهره به نوجوانان مبتلا به سندرم تخمدان پلی کیستیک در هشت جلسه ی 45 دقیقه ای در طول دوران تحصیل بصورت سخنرانی، پرسش و پاسخ که توسط پژوهشگر تهیه شده است، انجام میشود. بسته ارتقا سلامت نوجوان براساس الگوی دستورالعمل های بالینی نایس طراحی شده است. براساس این الگو، پس از جستجو در گایدلاین ها، کتب، بسته های سلامت جنسی کشورهای مختلف و نیز مقالات موجود، بسته طراحی گردید. سپس با استفاده از نظرات افراد متخصص و صاحب نظر شهرهای مختلف ایران با روش دلفی، بسته سلامت جنسی اعتباریابی گردید. این بسته، (در دو قسمت برای آموزش دهنده سبک زندگی نوجوان و نوجوان مبتلا) به گونه ای طراحی شده است که مطالب آموزشی آن در طول دوران تحصیل مهمترین ابعاد سلامت نوجوان را شامل شده است.
"گروه مداخله:" آموزش بصورت چهره به چهره به نوجوانان مبتلا به سندرم تخمدان پلی کیستیک در هشت جلسه ی 6045 دقیقه ای در طول دوران تحصیل بصورت سخنرانی، پرسش و پاسخ که توسط پژوهشگر تهیه شده است، انجام میشود. بسته ارتقا سلامت نوجوان براساس الگوی دستورالعمل های بالینی نایس طراحی شده است. براساس این الگو، پس از جستجو در گایدلاین ها، کتب، بسته های سلامت جنسی کشورهای مختلف و نیز مقالات موجود، بسته طراحی گردید. سپس با استفاده از نظرات افراد متخصص و صاحب نظر شهرهای مختلف ایران با روش دلفی، بسته سلامت جنسی اعتباریابی گردید. این بسته، (در دو قسمت برای آموزش دهنده سبک زندگی نوجوان و نوجوان مبتلا) به گونه ای طراحی شده است که مطالب آموزشی آن در طول دوران تحصیل مهمترین ابعاد سلامت نوجوان را شامل شده است.
Recruitment centers
#1
Name of recruitment center - English: girls High school in Tehran
Name of recruitment center - Persian: دبیرستانهای دخترانه واقع در تهران
Full name of responsible person - English: somayeh Abdolahian
Full name of responsible person - Persian: سمیه عبداللهیان
Street address - English: Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Street address - Persian: ولنجک، بولوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی، ساختمان شماره 2
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1983963113
Phone: +98 21 2243 9781
Fax:
Email: abdolahian.s@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Girls' High School in Tehran
Name of recruitment center - Persian: دبیرستانهای دخترانه واقع در تهران
Full name of responsible person - English: Somayeh Abdolahian
Full name of responsible person - Persian: سمیه عبداللهیان
Street address - English: Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Street address - Persian: ولنجک، بولوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی، ساختمان شماره 2
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1983963113
Phone: +98 21 2243 9781
Fax:
Email: Abdolahian.s@sbmu.ac.ir
Web page address:
Name of recruitment center - English: girlsGirls' High schoolSchool in Tehran Name of recruitment center - Persian: دبیرستانهای دخترانه واقع در تهران Full name of responsible person - English: somayehSomayeh Abdolahian Full name of responsible person - Persian: سمیه عبداللهیان Street address - English: Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Street address - Persian: ولنجک، بولوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی، ساختمان شماره 2 City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1983963113 Phone: +98 21 2243 9781 Fax: Email: abdolahian.sAbdolahian.s@sbmu.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Fatemeh Nahidi
Full name of responsible person - Persian: فاطمه ناهیدی
Street address - English: SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Street address - Persian: ولنجک، بولوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1983963113
Phone: +98 21 2243 9781
Fax:
Email: nahidifateme@sbmu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Afshin Zarghi
Full name of responsible person - Persian: افشین زرقی
Street address - English: SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran.
Street address - Persian: ولنجک، بولوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1983963113
Phone: +98 21 2243 9781
Fax:
Email: zarghi@sbmu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Fatemeh NahidiAfshin Zarghi Full name of responsible person - Persian: فاطمه ناهیدیافشین زرقی Street address - English: SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran. Street address - Persian: ولنجک، بولوار دانشجو، خیابان اعرابی، دانشگاه علوم پزشکی شهید بهشتی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1983963113 Phone: +98 21 2243 9781 Fax: Email: nahidifatemezarghi@sbmu.ac.ir Web page address:
Protocol summary
Study aim
Evaluation of the effects of adolescent health promotion training package on treatment of polycystic ovary syndrome
Design
This study is a longitudinal clinical trial.
Settings and conduct
In this study, 100 adolescents with poly cystic ovary syndrome (50 in each group) were randomly selected from the students in Tehran high schools. In the intervention group the training was done by lecture method and the second group was control (no training).
Participants/Inclusion and exclusion criteria
inclusion criteria: 14-18 years old girls, signed written consent form by parents and student; no history of disease; no drug use, no drug addiction.
exclusion criteria: Unwillingness of the teenager or her parents to participate in the study, Lack of teen participation in one-third of educational classes,
Adolescent drug use
Intervention groups
Face-to-face teaching to poly cystic ovary syndrome adolescents is conducted in eight 60-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.
Main outcome variables
• Changes in nutritional status score) FFQ, recall 24 h questionnaire(
• Changes in physical activity status score (Caspian questionnaire )
• Changes in the status of blood bio markers
• Changes in status of ultrasound items
• Changes in the quality of life of adolescents( kids Screening Questionnaire)
General information
Reason for update
Due to the conditions of school closures and changes in the implementation of this plan in Tehran girls' high schools, it is necessary to express it in this section as well.
Acronym
IRCT registration information
IRCT registration number:IRCT20200114046123N1
Registration date:2020-01-23, 1398/11/03
Registration timing:prospective
Last update:2022-02-28, 1400/12/09
Update count:1
Registration date
2020-01-23, 1398/11/03
Registrant information
Name
somayeh abdolahian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4429 8292
Email address
abdolahian.s@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-09-23, 1400/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary syndrome
Public title
Evaluation of the effects of adolescent health promotion training package on treatment of poly cystic ovary disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 14 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
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).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
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
2
Description
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
3
Description
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
4
Description
Anthropometric index
Timepoint
Before intervention and 6, 12 months after intervention
Method of measurement
weight,height, waist, and hip circumstance
Secondary outcomes
1
Description
Blood bio markers
Timepoint
before intervention and after 12 months
Method of measurement
Blood test
2
Description
Sonography Items
Timepoint
before intervention and after 12 months
Method of measurement
Transabdominal Sonography
Intervention groups
1
Description
"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.
Category
Lifestyle
2
Description
"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.