History
# Registration date Revision Id
2 2024-08-03, 1403/05/13 310791
1 2016-05-06, 1395/02/17 20875
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  • Protocol summary

    This study was performed with the aim of defining the effects of interventions based on Pender's model on preventable nutrition behavior of first degree relatives of colorectal cancer patients. This is a none blinded randomized case-control field trial study including 136 family members of colorectal cancer patients: after referring to Nemazi, Saadi (colorectal center) and Amir Hospital and taking patient's phone (with ethical license), called first degree relatives of patients. some of them who met inclusion criteria were selected (based on available sampling), then aims of research was explained and consent taken, according to prior plan, researcher made questionnaire given them, after completion the questionnaire were encoded, imported to spss and identified instructors which had more compatibility to nutrition performance of persons (perceived efficacy with 0.62, competitive demands and preferences with 0.38 and perceived barriers and profits with 0.28 had most compatibility to nutrition performance). Based on these structures, training program was planed then according to block randomization they allocated to 2 groups of intervention and control (each one 68 person). We educated based on identified program (intervention group divided to 2 groups and took part in 2 training sessions with focus on perceived efficacy, perceived barriers and profits). After 3 months, intervention and control group completed questionnaire again, during this time we reminded them with SMS or electronic massages. Data and information will be analyzed and pretest and post test results for both groups will be compared and if it be positive it will be done for control group.
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    این مطالعه با هدف تعیین تأثیر مداخلات مبتنی بر الگوی ارتقاء سلامت پندر بر رفتارهای تغذیه ای پیشگیرانه از سرطان کلورکتال در بستگان درجه یک بیماران مبتلا انجام گرفت.این مطالعه کورنشده تصادفی شده کار آزمائی در فیلد می باشد و جامعه مورد مطالعه از افراد خانواده درجه یک مبتلایان به سرطان کلورکتال مراجعه کننده به بیمارستانهای امیر، سعدی و نمازی شیراز می باشد. 136 نمونه بود که به دو گروه مداخله و شاهد تقسیم شدند.:پس از مراجعه به بیمارستانهای نمازی، سعدی (مرکز کولورکتال) و امیر شهر شیراز و دریافت شماره تماسهای بیماران (با همراه داشتن مجوز اخلاقی)، به افراد درجه1 خانواده بیماران مبتلا به سرطان کولورکتال تماس گرفتیم. آن دسته از خانواده‎هایی که واجدمعیارهای ورود به مطالعه بودند بر اساس نمونه گیری در دسترس انتخاب شدند، سپس اهداف مطالعه برای آنها توضیح داده شد، رضایتنامه کسب گردید. بر اساس برنامه قبلی، پرسشنامه محقق ساخته در اختیار آنها قرار داده شد؛ و بعد از تکمیل داده‎هاکدگذاری شده وارد SPSS شدند. و سازه‎هايي كه ارتباط بيشتري با عملكرد تغذيه‎اي افرادداشتند شناسايي كرده (خودکارآمدی درک شده 0.62،تقاضا وترجیحات رقابتی0.38. وموانع ومنافع درک شده 0.28، بیشترین ارتباط را با رفتار تغذیه ای افراد داشتند) و بر اساس آن سازه‎ها برنامه آموزشي با استفاده از نظر اساتید طراحی شده و افراد شركت كننده نیز به صورت بلوكي دردو گروه مداخله و كنترل(هر گروه 68نفر) تخصيص داده شدند. مداخلات آموزشي بر اساس برنامه ريزي تعیين شده انجام گرفت(افراد گروه مداخله به دو گروه تقسیم وبرای هر گروه دو جلسه آموزشی گروهی با تمرکز بر سازه‎های خودکارآمدی ومنافع وموانع درک شده تشکیل گردید) . بعد از 3ماه مجددا پرسشنامه‎ها توسط گروه مداخله و كنترل تكميل گردید در طي اين مدت پیامکها يا پیامهای اینترنتی جهت يادآوري در گروه مداخله انجام گرفت. اطلاعات حاصله مورد تجزیه و تحلیل قرار می گیرد و نتایج پیش آزمون و پس آزمون در گروه مداخله کنترل با هم مقایسه می شود در صورتی که نتیجه مثبت بود مداخله روی گروه کنترل هم انجام می شود .
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    Determining the effect of interventions based on Pender's health promotion model on preventive nutritional behaviors of colorectal cancer in first-degree relatives of patients with colorectal cancer.
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    تعیین تأثیر مداخلات مبتنی بر الگوی ارتقاء سلامت پندر بر رفتارهای تغذیه‌ای پیشگیرانه از سرطان کولورکتال در بستگان درجه یک بیماران مبتلا به سرطان کولورکتال.
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    A trial, no blinded, controlled, parallel-group, randomized, phase 2 clinical trial involving 136 participants
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    کارآزمایی، کور نشده، با گروه کنترل و گروه های موازی، تصادفی شده فاز 2 بر روی 136 شرکت کننده
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    The intervention group received four two-hour educational sessions, one session per week (4 weeks), based on constructs of pender's model. The study conducted to Namazi, Saadi, and Amir Hospitals affiliated with Shiraz University of Medical Sciences.
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    گروه مداخله چهار جلسه دو ساعته، هفته‌ای یک جلسه (4 هفته) آموزش مبتنی بر سازه‌های مدل پندر دریافت کردند. این مطالعه در بیمارستان‌های نمازی، سعدی و امیر وابسته به دانشگاه علوم پزشکی شیراز انجام شد.
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    The participants were first-degree relatives of patients with colorectal cancer. Inclusion criteria are:Being first-degree relatives of the patients with colorectal cancer; including their sister, brother, father, mother, and children; Confirmed diagnosis of colorectal cancer in the patient as documented in the medical record; The ages of between 18 - 60 years; Literate. Exclusion criteria were: Not participated in any educational workshops. previously; Lack of a chronic disease; Lack of mental retardation.
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    شرکت کنندگان بستگان درجه یک بیماران مبتلا به سرطان کولورکتال هستند. شرایط ورود: بستگان درجه یک بیماران با کولورکتال شامل خواهر، برادر، پدر، مادر و فرزندان، تشخیص تایید شده سرطان کولورکتال در بیمار که در پرونده پزشکی مستند شده است، سن بین 18 تا 60 سال، با سواد شرایط خروج: عدم شرکت قبلی در کارگاه آموزشیف نداشتن بیماری مزمن، نداشتن عقب ماندگی ذهنی
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    Intervention group: The research intervention was nutritional interventions based on Pender's health promotion model. Control group: Only routine educational interventions were provided by the healthcare personnel for the control group.
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    گروه مداخله: مداخله تحقیق مداخلات تغذیه ای مبتنی بر مدل ارتقای سلامت پندر هست. گروه کنترل: برای گروه کنترل، فقط مداخلات آموزشی توسط پرسنل مراقب سلامت برای /انها ارائه شد.
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    The primary outcome variable was colorectal cancer preventive nutritional behaviors, constructs of health promotion model of Pender, and Predictive constructs of nutritional behaviors to prevent colorectal cancer.
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    متغیر پیامد: رفتارهای تغذیه ای پیشگیری کننده از سرطان کولورکتال، سازه های مدل ارتقای سلامت و سازه های پیش بینی کننده رفتارهای تغذیه ای پیشگیری کننده از سرطان کولورکتال.
  • General information

    2015-11-11, 1394/08/20
    2016-07-10, 1395/04/20
    2016-01-10, 1394/10/20
    2016-10-15, 1395/07/24
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    The beginning and end date of recruitment of the patients was incorrectly recorded before the trial was registered. According to the new site, the information has been completed.
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    تاریخ شروع و پایان بیمارگیری به اشتباه قبل از کارازمایی ثبت شده است. با توجه به سایت جدید، اطلاعات تکمیل شد.
    the effect of Pender's model on nutrition behavior
    The effect of Pender's model on nutrition behavior
    تعیین تأثیر مداخلات مبتنی بر الگوی ارتقاء سلامت پندر بر رفتارهای تغذیه ای پیشگیرانه از سرطان کلورکتال دربستگان درجه یک افراد مبتلا
    تعیین تأثیر مداخلات مبتنی بر الگوی ارتقاء سلامت پندر بر رفتارهای تغذیه ای پیشگیرانه از سرطان کلورکتال در بستگان درجه یک افراد مبتلا
    Being first-degree relatives of the patients with colorectal cancer, including their sister, brother, father, mother, and children
    Confirmed diagnosis of colorectal cancer in the patient as documented in the medical record
    The ages of between 18 - 60 years
    Literate
    بستگان درجه یک بیماران شامل خواهر، برادر، پدر، مادر و فرزندان
    تشخیص تایید شده سرطان کولورکتال در بیمار که در پرونده پزشکی مستند شده است
    سن بین 18 تا 60 سال
    با سواد
    Not participated in any educational workshops previously
    Lack of a chronic disease
    Lack of mental retardation
    عدم شرکت قبلی در کارگاه آموزشی
    نداشتن بیماری مزمن
    نداشتن عقب ماندگی ذهنی
    No
    ندارد
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    The participants were first selected using Convenience sampling method and then randomly allocated to two intervention and control groups (68 people in each group) using 6-way and 4-way random block selection.
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    شرکت کنندگان ابتدا با استفاده از روش نمونه گیری در دسترس انتخاب شدند و سپس به صورت تصادفی به دو گروه مداخله و کنترل (هر گروه 68 نفر) با استفاده از بلوک های تصادفی 6 و 4 تایی تخصیص داده شدند.
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  • Primary outcomes

    #1
    preventable nutrition behavior
    Preventable nutrition behavior, Constructs of Pender's model, and predictors of preventive nutritional behaviors.
    رفتارهای تغذیه‎ای پیشگیرانه
    رفتارهای تغذیه‎ای پیشگیرانه، تغییرات سازه های مدل پندر، متغیرهای پیش بینی کننده رفتار تغذیه ای پیشگیری کننده .
  • Recruitment centers

    #1
    Name of recruitment center - English: Namazi Hospital
    Name of recruitment center - Persian: بیمارستان نمازی
    Full name of responsible person - English: Doctor Mehdi Akbartabar Turi
    Full name of responsible person - Persian: دکتر مهدی اکبرتبار طوری
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science, Martyr Motahary Blvd, Yasuj, Iran
    Street address - Persian: ایران، یاسوج، بلوار شهید مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی و فناوری دانشگاه، مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Namazi Hospital
    Name of recruitment center - Persian: بیمارستان نمازی
    Full name of responsible person - English: Dr Nazafarin Hosseini
    Full name of responsible person - Persian: دکتر نازآفرین حسینی
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science, Martyr Motahary Blvd, Yasuj, Iran
    Street address - Persian: ایران، یاسوج، بلوار شهید مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی و فناوری دانشگاه، مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Country: Iran (Islamic Republic of)
    Postal code: 7591994799
    Phone: +98 913 329 9427
    Fax:
    Email: hosseini.nazafarin@yums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Amir Hospital
    Name of recruitment center - Persian: بیمارستان امیر
    Full name of responsible person - English: Doctor Mehdi Akbartabar Turi
    Full name of responsible person - Persian: دکتر مهدی اکبرتبار طوری
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of University, Yasuj University of Medical Sciences, Martyr Motahary Blvd, Yasuj, Iran
    Street address - Persian: ایران، یاسوج، بلوار شهید مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی و فناوری دانشگاه، مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Amir Hospital
    Name of recruitment center - Persian: بیمارستان امیر
    Full name of responsible person - English: Dr Nazafarin Hosseini
    Full name of responsible person - Persian: دکتر نازآفرین حسینی
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of University, Yasuj University of Medical Sciences, Martyr Motahary Blvd, Yasuj, Iran
    Street address - Persian: ایران، یاسوج، بلوار شهید مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی و فناوری دانشگاه، مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Country: Iran (Islamic Republic of)
    Postal code: 7591994799
    Phone: +98 913 329 9427
    Fax:
    Email: hosseini.nazafarin@yums.ac.ir
    Web page address:
    #3
    Name of recruitment center - English: Saadi Hospital
    Name of recruitment center - Persian: بیمارستان سعدی
    Full name of responsible person - English: Doctor Mehdi Akbartabar Turi
    Full name of responsible person - Persian: دکتر مهدی اکبرتبار طوری
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of University, Yasuj University of Medical Sciences, Martyr Motahary Blvd, Yasuj, Iran
    Street address - Persian: ایران، یاسوج، بلوار شهید مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی و فناوری دانشگاه، مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Saadi Hospital
    Name of recruitment center - Persian: بیمارستان سعدی
    Full name of responsible person - English: Dr Nazafarin Hosseini
    Full name of responsible person - Persian: دکتر نازآفرین حسینی
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of University, Yasuj University of Medical Sciences, Martyr Motahary Blvd, Yasuj, Iran
    Street address - Persian: ایران، یاسوج، بلوار شهید مطهری، دانشگاه علوم پزشکی یاسوج، معاونت پژوهشی و فناوری دانشگاه، مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Country: Iran (Islamic Republic of)
    Postal code: 7591994799
    Phone: +98 913 329 9427
    Fax:
    Email: hosseini.nazafarin@yums.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Yasuj University of Medical sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی یاسوج
    Full name of responsible person - English: Doctor Mehdi Akbartabar turi
    Full name of responsible person - Persian: دکتر مهدی اکبر تبار طوری
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science,Blvd Martyr Motahary, Yasuj, Iran
    Street address - Persian: ایران یاسوج بلوار شهید مطهری دانشگاه علوم پزشکی یاسوج معاونت پژوهشی و فناوری دانشگاه مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    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: Dr Nazafarin Hosseini
    Full name of responsible person - Persian: دکتر نازآفرین حسینی
    Street address - English: Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science,Blvd Martyr Motahary, Yasuj, Iran
    Street address - Persian: ایران یاسوج بلوار شهید مطهری دانشگاه علوم پزشکی یاسوج معاونت پژوهشی و فناوری دانشگاه مدیریت پژوهشی دانشگاه علوم پزشکی یاسوج
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Country: Iran (Islamic Republic of)
    Postal code: 7591994799
    Phone: +98 74 3323 5141
    Fax:
    Email: hosseini.nazafarin@yums.ac.ir
    Web page address:
    empty
    Public
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    Domestic
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    Academic
    Yasuj University of Medical sciences
    Yasouj University of Medical Sciences
    دانشگاه علوم پزشکی یاسوج
    دانشگاه علوم پزشکی یاسوج
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Yasuj University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی یاسوج
    Full name of responsible person - English: Dr Nazafarin Hosseinichenar
    Full name of responsible person - Persian: دکتر ناز آفرین حسینی چنار
    Position - English: Ph.D of community health nursing-assestant professor
    Position - Persian: دکترای تخصصی پرستاری بهداشت جامعه-استادیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing and Midwifery College, Martyr Dr. Jalil St, Yasuj, Iran
    Street address - Persian: ایران یاسوج خیابان شهید دکتر جلیل دانشکده پرستاری و مامایی
    City - English: Yasuj
    City - Persian: یاسوج
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 74 3323 5141
    Mobile: 00
    Fax: +98 74 3334 6079
    Email: hosseinichenar@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr Nazafarin Hosseini
    Full name of responsible person - Persian: دکتر ناز آفرین حسینی
    Position - English: Ph.D of community health nursing- assistant professor
    Position - Persian: دکترای تخصصی پرستاری بهداشت جامعه-استادیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing and Midwifery College, Martyr Dr. Jalil St, Yasuj, Iran
    Street address - Persian: ایران یاسوج خیابان شهید دکتر جلیل دانشکده پرستاری و مامایی
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7591994799
    Phone: +98 74 3323 5141
    Mobile: +98 913 329 9427
    Fax:
    Email: hosseini.nazafarin@yums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Ysuj University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی یاسوج
    Full name of responsible person - English: Dr. Nazafarin Hosseinichenar
    Full name of responsible person - Persian: دکتر نازآفرین حسینی چنار
    Position - English: Ph.D of community health nursing- Assistant Professor
    Position - Persian: دکترای پرستاری بهداشت جامعه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing and Midwifery College, Martyr Dr. Jalil St, Yasuj, Iran
    Street address - Persian: ایران یاسوج خیابان شهید دکتر جلیل دانشکده پرستاری مامایی
    City - English: Yasuj
    City - Persian: یاسوج
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 74 3323 5141
    Mobile: +98 913 329 9427
    Fax: +98 74 3334 6079
    Email: hosseinichenar@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Nazafarin Hosseini
    Full name of responsible person - Persian: دکتر نازآفرین حسینی
    Position - English: Ph.D of community health nursing- Assistant Professor
    Position - Persian: دکترای پرستاری بهداشت جامعه
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing and Midwifery College, Martyr Dr. Jalil St, Yasuj, Iran
    Street address - Persian: ایران یاسوج خیابان شهید دکتر جلیل دانشکده پرستاری مامایی
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7591994799
    Phone: +98 74 3323 5141
    Mobile: +98 913 329 9427
    Fax: +98 74 3334 6079
    Email: hosseinichenar@yahoo.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Yasuj University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی یاسوج
    Full name of responsible person - English: Negar Keshavarz
    Full name of responsible person - Persian: نگار کشاورز
    Position - English: MS student of community health nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری بهداشت جامعه
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing and Midwifery College, St. Martyr Dr. Jalil, Yasuj, Iran
    Street address - Persian: ایران یاسوج خیابان شهید دکتر جلیل دانشکده پرستاری و مامایی
    City - English: Yasuj
    City - Persian: یاسوج
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: 00
    Mobile: +98 917 300 0538
    Fax:
    Email: negar.keshavarz@yums.ac.irkz7219@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Negar Keshavarz
    Full name of responsible person - Persian: نگار کشاورز
    Position - English: MSc student of community health nursing
    Position - Persian: دانشجوی کارشناسی ارشد پرستاری بهداشت جامعه
    Latest degree: master
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Nursing and Midwifery College, St. Martyr Dr. Jalil, Yasuj, Iran
    Street address - Persian: ایران یاسوج خیابان شهید دکتر جلیل دانشکده پرستاری و مامایی
    City - English: Yasuj
    City - Persian: یاسوج
    Province: Kohgilouyeh-va-Boyrahmad
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7591994799
    Phone: +98 74 3323 5141
    Mobile: +98 917 300 0538
    Fax:
    Email: kz7219@yahoo.com
    Web page address:
  • Sharing plan

    undecided
    no
    na
    undecided
    undecided
    na
    na
    empty
    Lack of time for manuscript writing
    empty
    نداشتن فرصت برای نگارش مقاله

Protocol summary

Study aim
Determining the effect of interventions based on Pender's health promotion model on preventive nutritional behaviors of colorectal cancer in first-degree relatives of patients with colorectal cancer.
Design
A trial, no blinded, controlled, parallel-group, randomized, phase 2 clinical trial involving 136 participants
Settings and conduct
The intervention group received four two-hour educational sessions, one session per week (4 weeks), based on constructs of pender's model. The study conducted to Namazi, Saadi, and Amir Hospitals affiliated with Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
The participants were first-degree relatives of patients with colorectal cancer. Inclusion criteria are:Being first-degree relatives of the patients with colorectal cancer; including their sister, brother, father, mother, and children; Confirmed diagnosis of colorectal cancer in the patient as documented in the medical record; The ages of between 18 - 60 years; Literate. Exclusion criteria were: Not participated in any educational workshops. previously; Lack of a chronic disease; Lack of mental retardation.
Intervention groups
Intervention group: The research intervention was nutritional interventions based on Pender's health promotion model. Control group: Only routine educational interventions were provided by the healthcare personnel for the control group.
Main outcome variables
The primary outcome variable was colorectal cancer preventive nutritional behaviors, constructs of health promotion model of Pender, and Predictive constructs of nutritional behaviors to prevent colorectal cancer.

General information

Reason for update
The beginning and end date of recruitment of the patients was incorrectly recorded before the trial was registered. According to the new site, the information has been completed.
Acronym
IRCT registration information
IRCT registration number: IRCT2015103124807N1
Registration date: 2016-05-06, 1395/02/17
Registration timing: prospective

Last update: 2024-08-07, 1403/05/17
Update count: 1
Registration date
2016-05-06, 1395/02/17
Registrant information
Name
Negar Keshavarz
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5141
Email address
negar.keshavarz@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
research management of Yasuj Medical Sciences
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-10-15, 1395/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Pender's Health Promotion Model application on preventive nutrition behaviors of colorectal cancer in first degree relatives of colorectal cancer patients.
Public title
The effect of Pender's model on nutrition behavior
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being first-degree relatives of the patients with colorectal cancer, including their sister, brother, father, mother, and children Confirmed diagnosis of colorectal cancer in the patient as documented in the medical record The ages of between 18 - 60 years Literate
Exclusion criteria:
Not participated in any educational workshops previously Lack of a chronic disease Lack of mental retardation
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were first selected using Convenience sampling method and then randomly allocated to two intervention and control groups (68 people in each group) using 6-way and 4-way random block selection.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
No

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yasuj University of Medical Sciences
Street address
Iran, Yasuj, Motahari martyr avenue, Yasuj University of Medical Sciences, research and technology deputy of university
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Approval date
2015-10-22, 1394/07/30
Ethics committee reference number
Yums.REC.1394.91

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
Z80.0
ICD-10 code description
Family history of malignant neoplasm of digestive organs

Primary outcomes

1

Description
Preventable nutrition behavior, Constructs of Pender's model, and predictors of preventive nutritional behaviors.
Timepoint
before intervention and 3 months after intervention
Method of measurement
researcher-made questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
intervention group divided to 2 groups and took part in 2 training sessions with focus on perceived efficacy, perceived barriers and profits. After 3 months, they completed questionnaire again during this time we reminded them with SMS or electronic massages.
Category
Prevention

2

Description
In control group wasn't done any intervention at the same time (of interventions for intervention group). After completion the interventions data and information will be analyzed and pretest and post test results for both groups will be compared and if it be positive same intervention will be done for control group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Dr Nazafarin Hosseini
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science, Martyr Motahary Blvd, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 913 329 9427
Email
hosseini.nazafarin@yums.ac.ir

2

Recruitment center
Name of recruitment center
Amir Hospital
Full name of responsible person
Dr Nazafarin Hosseini
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of University, Yasuj University of Medical Sciences, Martyr Motahary Blvd, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 913 329 9427
Email
hosseini.nazafarin@yums.ac.ir

3

Recruitment center
Name of recruitment center
Saadi Hospital
Full name of responsible person
Dr Nazafarin Hosseini
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of University, Yasuj University of Medical Sciences, Martyr Motahary Blvd, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 913 329 9427
Email
hosseini.nazafarin@yums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr Nazafarin Hosseini
Street address
Research Management of Yasuj University of Medical Sciences, Research and Technology Deputy of Yasuj University of Medical Science,Blvd Martyr Motahary, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5141
Email
hosseini.nazafarin@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr Nazafarin Hosseini
Position
Ph.D of community health nursing- assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College, Martyr Dr. Jalil St, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
Email
hosseini.nazafarin@yums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Nazafarin Hosseini
Position
Ph.D of community health nursing- Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College, Martyr Dr. Jalil St, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
+98 74 3334 6079
Email
hosseinichenar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Negar Keshavarz
Position
MSc student of community health nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery College, St. Martyr Dr. Jalil, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5141
Fax
Email
kz7219@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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