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Protocol summary
(1)Objectives: The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) on weight loss in obese and overweight adolescents.
(2)Designe: This study is a randomized controlled trial that will be conducted on obese or overweight children and their parents.
(3)Setting and conduct: 120 Overweight and obese adolescents aged 13–18 y is selected from schools, they randomly assigne to CBT or no treatment (control). Weight, height, hip and waist circumferences, BMI and body composition are measured. Food intake, Weight-Efficacy of Life style, quality of life, Physical activity are asked by valid questionnaires.
(4)Participants including major eligibility criteria: Participants will be included if they are overweight and obes 13-18 aged adolescent (BMI>85%). Participants will be excluded if they are involved in other weight-loss programs, are unwilling to attend sessions, using drugs which affect on weight or had a medical cause for their obesity (eg,endocrine disorders, etc).
(5) Intervention: Intervention group recieves CBT consisted of 6 weekly sessions, followed by five telephone or face to face sessions. All assessments will conducted at baseline and six month later inorder to evaluate effectiveness of this treatment method.
(6)main outcome measures (variables): Weight changes will be examined in this study.
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(1)Objectives: The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) on weight loss in obese and overweight adolescents. (2)Designe: This study is a randomized controlled trial that will be conducted on obese or overweight children and their parents. (3)Setting and conduct: 120 Overweight and obese adolescents aged 13–18 y is selected from schools, they randomly assigne to CBT or no treatment (control). Weight, height, hip and waist circumferences, BMI and body composition are measured. Food intake, Weight-Efficacy of Life style, quality of life, Physical activity are asked by valid questionnaires. (4)Participants including major eligibility criteria: Participants will be included if they are overweight and obes 13-18 aged adolescent (BMI>85%). Participants will be excluded if they are involved in other weight-loss programs, are unwilling to attend sessions, using drugs which affect on weight or had a medical cause for their obesity (eg,endocrine disorders, etc). (5) Intervention: Intervention group recieves CBT consisted of 6 weekly sessions, followed by five telephone or face to face sessions. All assessments will conducted at baseline and six month later inorder to evaluate effectiveness of this treatment method. (6)main outcome measures (variables): Weight changes will be examined in this study.
(1)اهداف: هدف این مطالعه ارزیابی اثر رفتار درمانی شناختی( CBT) بر کاهش وزن در بین نوجوانان چاق و دارای اضافه وزن است.
(2)طراحی: مطالعه حاضر،کارآزمایی کنترل شده تصادفی می باشد که بر روی کودکان چاق و والدین آنها صورت خواهد پذیرفت.
(3)نحوه انجام: 120 نوجوانان چاق و داراي اضافه وزن با سن 18-13 سال از 14 مدرسه متوسطه شهر قزوين انتخاب و به طور تصادفی به دو گروه مداخله CBT و کنترل تقسيم مي شوند. وزن، قد، دور کمر، دور باسن، نمايه توده بدني(BMI) ، ترکیب بدن آنان اندازه گيري شد. دريافت هاي غذايي، سبک زندگي مبتني بر خودکارآمدي وزن، کيفيت زندگي و رفتار فعاليت جسماني، کودکان بر اساس پرسشنامه هاي معتبر پرسیده خواهد شد.
(4)شرکت کنندگان: معیار ورود:نوجوانان چاق و دارای اضافه وزن حداقل سن 13 سال و حداکثر سن 18 سال، اندکس توده بدنی مساوی یا بالاتر از 85%.. معیار خروج: نوجوانانی که در سایر برنامه های کاهش وزن شرکت می کنند و یا مایل ، داروهای خاص اثر گذار بر روی وزن مصرف می کنند و یا علت پزشکی برای چاقیشان دارند مثل اختلالات هورمونی و غیره....
(5)مداخلات: گروه مداخله، CBT را در شش جلسه هفتگی و متعاقبا پنج تماس تلفنی دریافت خواهند نمود. تمام اندازه گیریهای مطالعه در ابتدای مطالعه و پس از شش ماه از انجام مداخله تکمیل خواهد شد.
(6)متغیرهای پیامد اصلی: تغییرات وزن در این مطالعه مورد بررسی قرار خواهد گرفت.
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(1)اهداف: هدف این مطالعه ارزیابی اثر رفتار درمانی شناختی( CBT) بر کاهش وزن در بین نوجوانان چاق و دارای اضافه وزن است. (2)طراحی: مطالعه حاضر،کارآزمایی کنترل شده تصادفی می باشد که بر روی کودکان چاق و والدین آنها صورت خواهد پذیرفت. (3)نحوه انجام: 120 نوجوانان چاق و داراي اضافه وزن با سن 18-13 سال از 14 مدرسه متوسطه شهر قزوين انتخاب و به طور تصادفی به دو گروه مداخله CBT و کنترل تقسيم مي شوند. وزن، قد، دور کمر، دور باسن، نمايه توده بدني(BMI) ، ترکیب بدن آنان اندازه گيري شد. دريافت هاي غذايي، سبک زندگي مبتني بر خودکارآمدي وزن، کيفيت زندگي و رفتار فعاليت جسماني، کودکان بر اساس پرسشنامه هاي معتبر پرسیده خواهد شد. (4)شرکت کنندگان: معیار ورود:نوجوانان چاق و دارای اضافه وزن حداقل سن 13 سال و حداکثر سن 18 سال، اندکس توده بدنی مساوی یا بالاتر از 85%.. معیار خروج: نوجوانانی که در سایر برنامه های کاهش وزن شرکت می کنند و یا مایل ، داروهای خاص اثر گذار بر روی وزن مصرف می کنند و یا علت پزشکی برای چاقیشان دارند مثل اختلالات هورمونی و غیره.... (5)مداخلات: گروه مداخله، CBT را در شش جلسه هفتگی و متعاقبا پنج تماس تلفنی دریافت خواهند نمود. تمام اندازه گیریهای مطالعه در ابتدای مطالعه و پس از شش ماه از انجام مداخله تکمیل خواهد شد. (6)متغیرهای پیامد اصلی: تغییرات وزن در این مطالعه مورد بررسی قرار خواهد گرفت.
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The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) on weight loss in obese and overweight adolescents
The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) on weight loss in obese and overweight adolescents
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هدف این مطالعه ارزیابی اثر رفتار درمانی شناختی( CBT) بر کاهش وزن در بین نوجوانان چاق و دارای اضافه وزن است.
هدف این مطالعه ارزیابی اثر رفتار درمانی شناختی( CBT) بر کاهش وزن در بین نوجوانان چاق و دارای اضافه وزن است.
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The present study is a prospective randomized controlled trial (RCT) comparing the effect of CBT on weight reduction among overweight and obese Iranian adolescents.
The present study is a prospective randomized controlled trial (RCT) comparing the effect of CBT on weight reduction among overweight and obese Iranian adolescents.
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مطالعه حاضر یک کارآزمایی تصادفیسازی و کنترلشده آیندهنگر است که به مقایسه تأثیر CBT بر کاهش وزن در نوجوانان ایرانی دارای اضافه وزن و چاق پرداخته است.
مطالعه حاضر یک کارآزمایی تصادفیسازی و کنترلشده آیندهنگر است که به مقایسه تأثیر CBT بر کاهش وزن در نوجوانان ایرانی دارای اضافه وزن و چاق پرداخته است.
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The adolescents will be recruited from four outpatient pediatric clinics in Qazvin .
The adolescents will be recruited from four outpatient pediatric clinics in Qazvin .
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این نوجوانان از چهار کلینیک سرپایی اطفال در قزوین شرکت خواهند شد.
این نوجوانان از چهار کلینیک سرپایی اطفال در قزوین شرکت خواهند شد.
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Inclusion criteria: age 13–18 years, BMI ≥85th percentile for age and gender, and ability to attend CBT sessions. Exclusion criteria : adolescents with other causes of obesity such as Cushing Disease and hypoparathyroidism, being pregnant, having clinical mental health conditions or psychosis, taking specific medications that affected their weight (e.g. corticosteroids, anxiolytics), and participating in another weight loss RCT.
Inclusion criteria: age 13–18 years, BMI ≥85th percentile for age and gender, and ability to attend CBT sessions. Exclusion criteria : adolescents with other causes of obesity such as Cushing Disease and hypoparathyroidism, being pregnant, having clinical mental health conditions or psychosis, taking specific medications that affected their weight (e.g. corticosteroids, anxiolytics), and participating in another weight loss RCT.
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معیارهای ورود: سن 13 تا 18 سال، BMI ≥85 صدک برای سن و جنسیت، و توانایی شرکت در جلسات CBT. معیارهای خروج: نوجوانان مبتلا به سایر علل چاقی مانند بیماری کوشینگ و کم کاری پاراتیروئید، باردار بودن، داشتن شرایط سلامت روان بالینی یا روان پریشی، مصرف داروهای خاصی که بر وزن آنها تأثیر می گذارد (مانند کورتیکواستروئیدها، داروهای ضد اضطراب)، و شرکت در RCT کاهش وزن دیگر.
معیارهای ورود: سن 13 تا 18 سال، BMI ≥85 صدک برای سن و جنسیت، و توانایی شرکت در جلسات CBT. معیارهای خروج: نوجوانان مبتلا به سایر علل چاقی مانند بیماری کوشینگ و کم کاری پاراتیروئید، باردار بودن، داشتن شرایط سلامت روان بالینی یا روان پریشی، مصرف داروهای خاصی که بر وزن آنها تأثیر می گذارد (مانند کورتیکواستروئیدها، داروهای ضد اضطراب)، و شرکت در RCT کاهش وزن دیگر.
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CBT treatment sessions will be based on treatment strategies in the intervention group comprised six face-to-face sessions for adolescents and two sessions for their parents. In all sessions, nutritional recommendations and diet of the adolescents will be evaluated.
CBT treatment sessions will be based on treatment strategies in the intervention group comprised six face-to-face sessions for adolescents and two sessions for their parents. In all sessions, nutritional recommendations and diet of the adolescents will be evaluated.
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جلسات درمان CBT بر اساس راهبردهای درمانی در گروه مداخله شامل شش جلسه حضوری برای نوجوانان و دو جلسه برای والدین آنها خواهد بود. در تمامی جلسات توصیه های تغذیه ای و رژیم غذایی نوجوانان مورد ارزیابی قرار می گیرد.
جلسات درمان CBT بر اساس راهبردهای درمانی در گروه مداخله شامل شش جلسه حضوری برای نوجوانان و دو جلسه برای والدین آنها خواهد بود. در تمامی جلسات توصیه های تغذیه ای و رژیم غذایی نوجوانان مورد ارزیابی قرار می گیرد.
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Primary outcomes will be changes in BMI, Child Dietary Self-Efficacy Scale (CDSS), Weight Efficacy Lifestyle questionnaire (WEL), Physical Exercise Self-Efficacy Scale (PES), Pediatric Quality of Life Inventory (PedsQL™ 4.0 Generic Core Scales), and self-reported physical activity and diet
Primary outcomes will be changes in BMI, Child Dietary Self-Efficacy Scale (CDSS), Weight Efficacy Lifestyle questionnaire (WEL), Physical Exercise Self-Efficacy Scale (PES), Pediatric Quality of Life Inventory (PedsQL™ 4.0 Generic Core Scales), and self-reported physical activity and diet
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پیامدهای اولیه تغییرات در BMI، مقیاس خودکارآمدی رژیم غذایی کودک (CDSS)، پرسشنامه سبک زندگی کارآمدی وزن (WEL)، مقیاس خودکارآمدی تمرینات بدنی (PES)، پرسشنامه کیفیت زندگی کودکان (PedsQL™ 4.0 Generic Core Scal) خواهد بود. و فعالیت بدنی و رژیم غذایی خود گزارش شده است
پیامدهای اولیه تغییرات در BMI، مقیاس خودکارآمدی رژیم غذایی کودک (CDSS)، پرسشنامه سبک زندگی کارآمدی وزن (WEL)، مقیاس خودکارآمدی تمرینات بدنی (PES)، پرسشنامه کیفیت زندگی کودکان (PedsQL™ 4.0 Generic Core Scal) خواهد بود. و فعالیت بدنی و رژیم غذایی خود گزارش شده است
General information
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2016-04-03, 1395/01/15
2017-02-03, 1395/11/15
20162017-0402-03 00:00:00
2017-01-19, 1395/10/30
2017-06-15, 1396/03/25
2017-0106-1915 00:00:00
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2017-02-03, 1395/11/15
2017-02-03 00:00:00
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2017-08-12, 1396/05/21
2017-08-12 00:00:00
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2018-03-06, 1396/12/15
2018-03-06 00:00:00
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We had been registered this trial 6 years before prospectively. But it has recently changed unto a retrospective status. We received the following message from IRCT “ Please note that the existing validation errors in your trial is because this trial has been approved while the previous version of IRCT software was in use. Please check all the errors carefully and update accordingly. some of the major changes include reformatting protocol summary, entering inclusion and exclusion criteria in "one phrase for each criteria" format, providing a sharing plan, and adding more contact information.” Therefore, we have now updated recruiting time.
We had been registered this trial 6 years before prospectively. But it has recently changed unto a retrospective status. We received the following message from IRCT “ Please note that the existing validation errors in your trial is because this trial has been approved while the previous version of IRCT software was in use. Please check all the errors carefully and update accordingly. some of the major changes include reformatting protocol summary, entering inclusion and exclusion criteria in "one phrase for each criteria" format, providing a sharing plan, and adding more contact information.” Therefore, we have now updated recruiting time.
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ما این آزمایش را 6 سال قبل ثبت نام کرده بودیم. اما اخیراً به وضعیت گذشته نگر تغییر یافته است. ما پیام زیر را از IRCT دریافت کردیم: «لطفاً توجه داشته باشید که خطاهای اعتبارسنجی موجود در آزمایش شما به این دلیل است که این آزمایش زمانی تأیید شده است که نسخه قبلی نرمافزار IRCT در حال استفاده بود. لطفاً تمام خطاها را به دقت بررسی کنید و متناسب با آن به روز رسانی کنید. برخی از تغییرات عمده شامل قالب بندی مجدد خلاصه پروتکل، وارد کردن معیارهای گنجاندن و حذف در قالب "یک عبارت برای هر معیار"، ارائه طرح اشتراک گذاری و افزودن اطلاعات تماس بیشتر است. بنابراین، ما اکنون زمان استخدام را به روز کرده ایم.
ما این آزمایش را 6 سال قبل ثبت نام کرده بودیم. اما اخیراً به وضعیت گذشته نگر تغییر یافته است. ما پیام زیر را از IRCT دریافت کردیم: «لطفاً توجه داشته باشید که خطاهای اعتبارسنجی موجود در آزمایش شما به این دلیل است که این آزمایش زمانی تأیید شده است که نسخه قبلی نرمافزار IRCT در حال استفاده بود. لطفاً تمام خطاها را به دقت بررسی کنید و متناسب با آن به روز رسانی کنید. برخی از تغییرات عمده شامل قالب بندی مجدد خلاصه پروتکل، وارد کردن معیارهای گنجاندن و حذف در قالب "یک عبارت برای هر معیار"، ارائه طرح اشتراک گذاری و افزودن اطلاعات تماس بیشتر است. بنابراین، ما اکنون زمان استخدام را به روز کرده ایم.
age 13–18 years
BMI ≥85th percentile for age and gender
ability to attend CBT sessions
age 13–18 years BMI ≥85th percentile for age and gender ability to attend CBT sessions
سن 13 تا 18 سال
صدک برای سن و جنس
توانایی شرکت در جلسات درمان شناختی – رفتاری
سن 13 تا 18 سال صدک برای سن و جنس توانایی شرکت در جلسات درمان شناختی – رفتاری
Cushing Disease
hypoparathyroidism
being pregnant
having clinical mental health conditions or psychosis, taking specific medications that affected their weight
participating in another weight loss RCT
Cushing Disease hypoparathyroidism being pregnant having clinical mental health conditions or psychosis, taking specific medications that affected their weight participating in another weight loss RCT
بیماری کوشینگ
کم کاری پاراتیروئید
باردار بودن
داشتن شرایط سلامت روان بالینی یا روان پریشی، مصرف داروهای خاصی که بر وزن آنها تأثیر می گذارد
شرکت در RCT کاهش وزن دیگر
بیماری کوشینگ کم کاری پاراتیروئید باردار بودن داشتن شرایط سلامت روان بالینی یا روان پریشی، مصرف داروهای خاصی که بر وزن آنها تأثیر می گذارد شرکت در RCT کاهش وزن دیگر
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Each adolescent will be recruited at the pediatric clinic to which they referred for treatment. Randomization will be performed after checking eligibility criteria, signing of informed consent, and baseline assessment. An independent biostatistician will randomize the adolescents into two groups (CBT and TAU) using software program and stratifying with the pediatric clinics.
Each adolescent will be recruited at the pediatric clinic to which they referred for treatment. Randomization will be performed after checking eligibility criteria, signing of informed consent, and baseline assessment. An independent biostatistician will randomize the adolescents into two groups (CBT and TAU) using software program and stratifying with the pediatric clinics.
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هر یک از نوجوانان در کلینیک اطفال که برای درمان به آن ارجاع می شوند، درمطالعه شرکت خواهند کرد. تصادفی سازی پس از بررسی معیارهای واجد شرایط بودن، امضای رضایت آگاهانه و ارزیابی پایه انجام می پذیرد. یک متخصص آمار زیستی مستقل، نوجوانان را با استفاده از نرم افزار به دو گروه تصادفی سازی خواهد کرد.
هر یک از نوجوانان در کلینیک اطفال که برای درمان به آن ارجاع می شوند، درمطالعه شرکت خواهند کرد. تصادفی سازی پس از بررسی معیارهای واجد شرایط بودن، امضای رضایت آگاهانه و ارزیابی پایه انجام می پذیرد. یک متخصص آمار زیستی مستقل، نوجوانان را با استفاده از نرم افزار به دو گروه تصادفی سازی خواهد کرد.
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Recruitment centers
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Name of recruitment center - English: Schools
Name of recruitment center - Persian: مدارس
Full name of responsible person - English: Seyedeh Fatemeh Miri
Full name of responsible person - Persian: سیده فاطمه میری
Street address - English: Medical Science University, Shahid Bahonar Blvd
Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی
City - English: Qazvin
City - Persian: قزوین
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: outpatient pediatric clinics
Name of recruitment center - Persian: کلینیک های سرپایی کودکان
Full name of responsible person - English: Seyedeh Fatemeh Miri
Full name of responsible person - Persian: سیده فاطمه میری
Street address - English: Medical Science University, Shahid Bahonar Blvd
Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 3419759811
Phone: +98 28 3369 4014
Fax:
Email: f.miri@qums.ac.ir
Web page address:
Name of recruitment center - English: Schoolsoutpatient pediatric clinics Name of recruitment center - Persian: مدارسکلینیک های سرپایی کودکان Full name of responsible person - English: Seyedeh Fatemeh Miri Full name of responsible person - Persian: سیده فاطمه میری Street address - English: Medical Science University, Shahid Bahonar Blvd Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی City - English: Qazvin City - Persian: قزوین Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 3419759811 Phone: +98 28 3369 4014 Fax: Email: f.miri@qums.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Vice chancellor for research, Qazvin Medical Science University
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Vice chancellor for research, Qazvin Medical Science University
Full name of responsible person - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین
Street address - English: Medical Science University, Shahid Bahonar Blvd
Street address - Persian: بلوار شهید باهنر، دانشگاه علوم پزشکی
City - English: Qazvin
City - Persian: قزوین
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Vice chancellor for research, Qazvin Medical Science University
Full name of responsible person - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین
Street address - English: Medical Science University, Shahid Bahonar Blvd
Street address - Persian: بلوار شهید باهنر، دانشگاه علوم پزشکی
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Country: Iran (Islamic Republic of)
Postal code: 3419759811
Phone: +98 28 3369 4014
Fax:
Email: Sdh@qums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Vice chancellor for research, Qazvin Medical Science University Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین Full name of responsible person - English: Vice chancellor for research, Qazvin Medical Science University Full name of responsible person - Persian: معاونت پژوهشی دانشگاه علوم پزشکی قزوین Street address - English: Medical Science University, Shahid Bahonar Blvd Street address - Persian: بلوار شهید باهنر، دانشگاه علوم پزشکی City - English: Qazvin City - Persian: قزوین Province: Qazvin Country: Iran (Islamic Republic of) Postal code: 3419759811 Phone: +98 28 3369 4014 Fax: Email: Sdh@qums.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Vice chancellor for research, Qazvin Medical Science University
Qazvin University of Medical Sciences
Vice chancellor for research, Qazvin University of Medical Science UniversitySciences
معاونت پژوهشی دانشگاه علوم پزشکی قزوین
دانشگاه علوم پزشکی قزوین
معاونت پژوهشی دانشگاه علوم پزشکی قزوین
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Qazvin Medical Science University
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Seyedeh Fatemeh Miri
Full name of responsible person - Persian: سیده فاطمه میری
Position - English: MSc student
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin Medical University, Shahid Bahoonar Blvd
Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 59811-34197
Phone: +98 28 3337 4872
Mobile: +98 912 882 1974
Fax:
Email: fmiri.nut@gmail.com; f.miri@qums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Qazvin Medical Science University
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Seyedeh Fatemeh Miri
Full name of responsible person - Persian: سیده فاطمه میری
Position - English: MSc student
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree: master
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin Medical University, Shahid Bahoonar Blvd
Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی قزوین
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 59811-34197
Phone: +98 28 3337 4872
Mobile: +98 912 882 1974
Fax:
Email: f.miri@qums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Qazvin Medical Science University Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین Full name of responsible person - English: Seyedeh Fatemeh Miri Full name of responsible person - Persian: سیده فاطمه میری Position - English: MSc student Position - Persian: دانشجوی کارشناسی ارشد Latest degree: master Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Qazvin Medical University, Shahid Bahoonar Blvd Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی قزوین City - English: Qazvin City - Persian: قزوین Province: Qazvin Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 59811-34197 Phone: +98 28 3337 4872 Mobile: +98 912 882 1974 Fax: Email: fmiri.nut@gmail.com; f.miri@qums.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Social Determinants of Health Research Center, Qazvin University of Medical Sciences
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین/مرکز تحقیقات SDH
Full name of responsible person - English: Amir H Pakpour
Full name of responsible person - Persian: امیر پاکپور حاجی آقا
Position - English: PhD, Health education
Position - Persian: پی اچ دی آموزش بهداشت
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Social Determinants of Health Research Center
Street address - Persian: بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین،مرکز تحقیقات SDH
City - English: Qazvin
City - Persian: قزوین
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 28 3323 9259
Mobile: +98 919 314 4371
Fax:
Email: Pakpour_amir@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Amir H Pakpour
Full name of responsible person - Persian: امیر پاکپور حاجی آقا
Position - English: PhD, Health education
Position - Persian: پی اچ دی آموزش بهداشت
Latest degree: phd
Area of specialty/work: 14
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Social Determinants of Health Research Center
Street address - Persian: بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین،مرکز تحقیقات SDH
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3419759811
Phone: +98 28 3323 9259
Mobile: +98 919 314 4371
Fax:
Email: Pakpour_amir@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Social Determinants of Health Research Center, Qazvin University of Medical Sciences Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین/مرکز تحقیقات SDH Full name of responsible person - English: Amir H Pakpour Full name of responsible person - Persian: امیر پاکپور حاجی آقا Position - English: PhD, Health education Position - Persian: پی اچ دی آموزش بهداشت Latest degree: phd Area of specialty/work: 014 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Social Determinants of Health Research Center Street address - Persian: بلوار شهید باهنر، دانشگاه علوم پزشکی قزوین،مرکز تحقیقات SDH City - English: Qazvin City - Persian: قزوین Province: Qazvin Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3419759811 Phone: +98 28 3323 9259 Mobile: +98 919 314 4371 Fax: Email: Pakpour_amir@yahoo.com Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Qazvin Medical Science University
Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین
Full name of responsible person - English: Seyedeh Fatemeh Miri
Full name of responsible person - Persian: سیده فاطمه میری
Position - English: MSc student
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Medical Science University, Shahid Bahoonar Blvd
Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی
City - English: Qazvin
City - Persian: قزوین
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code:
Phone: +98 28333360015
Mobile: +98 912 882 1974
Fax:
Email: f.miri@qums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Seyedeh Fatemeh Miri
Full name of responsible person - Persian: سیده فاطمه میری
Position - English: MSc student
Position - Persian: دانشجوی کارشناسی ارشد
Latest degree: master
Area of specialty/work: 34
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Medical Science University, Shahid Bahoonar Blvd
Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی
City - English: Qazvin
City - Persian: قزوین
Province: Qazvin
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 3419759811
Phone: +9828333360015
Mobile: +98 912 882 1974
Fax:
Email: f.miri@qums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Qazvin Medical Science University Name of organization / entity - Persian: دانشگاه علوم پزشکی قزوین Full name of responsible person - English: Seyedeh Fatemeh Miri Full name of responsible person - Persian: سیده فاطمه میری Position - English: MSc student Position - Persian: دانشجوی کارشناسی ارشد Latest degree: master Area of specialty/work: 034 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Medical Science University, Shahid Bahoonar Blvd Street address - Persian: بلوار باهنر، دانشگاه علوم پزشکی City - English: Qazvin City - Persian: قزوین Province: Qazvin Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 3419759811 Phone: +98 283333600159828333360015 Mobile: +98 912 882 1974 Fax: Email: f.miri@qums.ac.ir Web page address:
Sharing plan
no
no
no
no
no
no
no
no
no
no
no
no
no
no
empty
There is no further information
There is no further information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) on weight loss in obese and overweight adolescents
Design
The present study is a prospective randomized controlled trial (RCT) comparing the effect of CBT on weight reduction among overweight and obese Iranian adolescents.
Settings and conduct
The adolescents will be recruited from four outpatient pediatric clinics in Qazvin .
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 13–18 years, BMI ≥85th percentile for age and gender, and ability to attend CBT sessions. Exclusion criteria : adolescents with other causes of obesity such as Cushing Disease and hypoparathyroidism, being pregnant, having clinical mental health conditions or psychosis, taking specific medications that affected their weight (e.g. corticosteroids, anxiolytics), and participating in another weight loss RCT.
Intervention groups
CBT treatment sessions will be based on treatment strategies in the intervention group comprised six face-to-face sessions for adolescents and two sessions for their parents. In all sessions, nutritional recommendations and diet of the adolescents will be evaluated.
Main outcome variables
Primary outcomes will be changes in BMI, Child Dietary Self-Efficacy Scale (CDSS), Weight Efficacy Lifestyle questionnaire (WEL), Physical Exercise Self-Efficacy Scale (PES), Pediatric Quality of Life Inventory (PedsQL™ 4.0 Generic Core Scales), and self-reported physical activity and diet
General information
Reason for update
We had been registered this trial 6 years before prospectively. But it has recently changed unto a retrospective status. We received the following message from IRCT “ Please note that the existing validation errors in your trial is because this trial has been approved while the previous version of IRCT software was in use. Please check all the errors carefully and update accordingly. some of the major changes include reformatting protocol summary, entering inclusion and exclusion criteria in "one phrase for each criteria" format, providing a sharing plan, and adding more contact information.” Therefore, we have now updated recruiting time.
Acronym
IRCT registration information
IRCT registration number:IRCT2016110530707N1
Registration date:2017-01-22, 1395/11/03
Registration timing:prospective
Last update:2023-06-13, 1402/03/23
Update count:1
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Seyedeh Fatemeh Miri
Name of organization / entity
Qazvin Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
f.miri@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-06-15, 1396/03/25
Actual recruitment start date
2017-02-03, 1395/11/15
Actual recruitment end date
2017-08-12, 1396/05/21
Trial completion date
2018-03-06, 1396/12/15
Scientific title
Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents
Public title
Effectiveness of the Cognitive behavioral therapy(CBT) in improving nutritional and weight status in overweight adolescents
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 13–18 years
BMI ≥85th percentile for age and gender
ability to attend CBT sessions
Exclusion criteria:
Cushing Disease
hypoparathyroidism
being pregnant
having clinical mental health conditions or psychosis, taking specific medications that affected their weight
participating in another weight loss RCT
Age
From 13 years old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
110
Actual sample size reached:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Each adolescent will be recruited at the pediatric clinic to which they referred for treatment. Randomization will be performed after checking eligibility criteria, signing of informed consent, and baseline assessment. An independent biostatistician will randomize the adolescents into two groups (CBT and TAU) using software program and stratifying with the pediatric clinics.
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
Qazvin Medical Science University Ethics committee
Street address
Medical Science University, Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
IR.QUMS.REC.1395.172
Health conditions studied
1
Description of health condition studied
overweight or obesity
ICD-10 code
E65, E66,
ICD-10 code description
Obesity and other hyperalimentation / Obesity due to excess calories
Primary outcomes
1
Description
weight
Timepoint
before intervention and after 6 month
Method of measurement
balance scale
Secondary outcomes
1
Description
body mass index
Timepoint
before and after intervention
Method of measurement
weigh(kg)/(height)2
2
Description
waist circumference
Timepoint
baseline and 6 month after intervention
Method of measurement
meter
3
Description
hip circumference
Timepoint
at baseline and 6 month after intervention
Method of measurement
meter
4
Description
energy intake
Timepoint
at baseline and 6 month after intervention
Method of measurement
food frequency questionnair
5
Description
physical activity
Timepoint
at baseline and 6 month after intervention
Method of measurement
physical activity questionnair
6
Description
health-related quality of life
Timepoint
at baseline and 6 month after intervention
Method of measurement
quality of life questionnaire
7
Description
self efficacy
Timepoint
at baseline and 6 month after intervention
Method of measurement
questionnaire
8
Description
body composition
Timepoint
at baseline and 6 month after intervention
Method of measurement
body analyser
Intervention groups
1
Description
Intervention group: Cognitive behavioral therapy (CBT) will be used in this study. Intervention group will receive CBT consisted of six weekly, face to face sessions.
Category
Behavior
2
Description
Control group: This group will not receive any treatment during the study.they will receive counseling sessions at the end of study similar to intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
outpatient pediatric clinics
Full name of responsible person
Seyedeh Fatemeh Miri
Street address
Medical Science University, Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3369 4014
Email
f.miri@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Vice chancellor for research, Qazvin Medical Science University
Street address
Medical Science University, Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3369 4014
Email
Sdh@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin Medical Science University
Full name of responsible person
Seyedeh Fatemeh Miri
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Qazvin Medical University, Shahid Bahoonar Blvd
City
Qazvin
Province
Qazvin
Postal code
59811-34197
Phone
+98 28 3337 4872
Fax
Email
f.miri@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir H Pakpour
Position
PhD, Health education
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd, Social Determinants of Health Research Center
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3323 9259
Fax
Email
Pakpour_amir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Miri
Position
MSc student
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Medical Science University, Shahid Bahoonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+9828333360015
Fax
Email
f.miri@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD