History
# Registration date Revision Id
4 2020-04-11, 1399/01/23 129726
3 2019-11-26, 1398/09/05 112139
2 2017-05-31, 1396/03/10 25949
1
This trial has some update history items in old IRCT format. To see these history items click here.
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    Background and objective: physical activity during pregnancy has been associated with improved skills of offspring and their development. The aim of this study was to determine the effects of physical activity during pregnancy on social development among offspring in the first and three months of life. Materials and Methods: In this experimental study, 40 mother-infant pairs were selected who were clients of healthcare and medical centers in Bojnourd then they were divided in two experimental and control groups in 2015-2016. The experimental group benefited from 16 sessions physical intervention and control group who had not any physical activities regularly. Finally, communication and personal- social skills of infants in both groups were evaluated by Ages and Stages questionnaire (ASQ 3) in two periods of one and three months.
    empty
    زمینه و هدف: فعالیت بدنی در دوران بارداری با بهبود مهارت های فرزندان و رشد آن ها همراه است. تحقیق حاضر نیز با هدف تعیین اثرات فعالیت بدنی طی بارداری بر رشد اجتماعی فرزندان در سه ماه اول زندگی انجام شد. مواد و روش ها: این مطالعه کارآزمایی روی 40 جفت مادر- فرزند مراجعه کننده به مراکز بهداشتی و خدمات درمانی شهرستان بجنورد در دو گروه آزمایش و کنترل در سال 95-1394 انجام گرفت. گروه آزمایش، از یک دوره مداخله حرکتی 16 جلسه ای سود برده و گروه کنترل هیچ فعالیت هدفمندی را به طور منظم انجام نمی دادند. سرانجام مهارت های ارتباطی و فردی- اجتماعی فرزندان دو گروه آزمایش و کنترل با استفاده از پرسشنامه سنین-مرحله Ages and Stages Questionnaire III (ASQ 3) در دو دوره یک و سه ماهگی مورد بررسی قرار گرفتند. داده ها از طریق آزمون تحلیل واریانس اندازه تکراری (2×2) تجزیه و تحلیل شدند.
    empty
    empty
    The aim of this study was to examine the effects of maternal prenatal selected activities on cognitive, motor, and social development of infants.
    empty
    هدف این مطالعه تعیین اثر فعالیت بدنی مادران طی بارداری بر رشد حرکتی، شناختی و اجتماعی اطفال است
    empty
    Using the G-power software, the sample size was determined and the women in the study were randomly assigned into two experimental (n=20) and control (n=20) groups. According to the considered criteria, the sample size was reduced to 36 pairs (10%).
    empty
    با استفاده از نرم افزار جی پاور، حجم نمونه تعیین شد و به طور تصادفی در دو گروه آزمایش (n=20) و کنترل (n=20)قرار گرفتند.بر اساس معیارهای ورود و خروج، تعداد نمونه ها به 36 نفر کاهش یافت.
    empty
    Participants were pregnant women visiting healthcare centers of Bojnourd in 2016-17. In this project, 40 mother-child pairs were evaluated. The participants were recruited by contacting midwives, family education centers or families.
    empty
    شرکت کنندگان زنان باردار مراجعه کننده به مراکز بهداشت شهرستان بجنورد طی سالهای 1396-97 بودند. در این پروژه، 40 جفت مادر و فرزند انتخاب شدند.شرکت کنندگان توسط ماماها، مراکز آموزش خانواده و اقوام مطلع شدند.
    empty
    pregnant women
    empty
    زنان باردار
    empty
    data were gathered from 40 mother-neonate pairs who were selected from healthcare centers and hospitals (2016-2017) and their infants were evaluated for gross and fine motor skills, cognitive and social skills at ages of 1 and 3 months (final N=36). Pregnant mothers were active in the second and third trimesters. In control group, mothers received the normal medical care.
    empty
    داده ها از 40 جفت مادر و طفل مراجعه کننده به مراکز سلامت و بیمارستانها تههیه شد و اطفال مورد ارزیابی رشدی طی یک و سه ماهگی قرار گرفتند. مادران طی سه ماهه دوم و سوم فعال بودند. گروه کنترل مراقبتهای پزشکی نرمال را دریافت کردند.
    empty
    The data from infants were collected in motor, cognitive and social domains during 1 and 3 months of age.
    empty
    داده ها شامل مهارت های حرکتی، شناختی و اجتماعی اطفال طی یک و سه ماهگی بود.
  • General information

    empty
    to complete the data
    empty
    کامل شدن داده ها
    Effect of physical activity during pregnancy on development of Social skills in infants
    Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants
    تأثیر فعالیت بدنی طی بارداری بر رشد مهارت های اجتماعی اطفال
    تأثیر فعالیت بدنی طی بارداری بر رشد مهارت های حرکتی، شناختی و اجتماعی اطفال
    Effect of physical activity during pregnancy on development of Social skills in infants
    Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants
    تأثیر فعالیت بدنی طی بارداری بر رشد مهارت های اجتماعی اطفال
    تأثیر فعالیت بدنی طی بارداری بر رشد مهارت های حرکتی، شناختی و اجتماعی اطفال
    The inclusion criteria for the study were: all nulliparous pregnant women; non-athletes and house wives who admitted to city hospitals and prenatal care centers of Bojnurd. They had a gestational age of 23 to 34 weeks and according to their health records, body mass index (BMI) before pregnancy (20 to 24.9 kilograms per square meter) was normal. Similarly they had a normal singleton pregnancy at term (37-41 weeks) with the birth of a healthy baby (without any apparent anomalies). The subjects had no previous history of any underlying disease and were controlled based on their medical records.
    معيار ورود: زنان باردار نخست زا ، غير ورزشكار و خانه دار 22-30 ساله در شهرستان بجنورد - داراي سن حاملگي23 تا 34 و شاخص توده بدني پیش از بارداری(20 تا 9/24 كيلوگرم بر متر مربع) طبیعی -دارای حاملگی طبیعی تک قلویی در زمان ترم (37-41 هفته) با تولد نوزاد سالم (بدون هرگونه ناهنجاری ظاهری) . افراد گروه کنترل نیز فعالیت بدنی هدفدار و منظمی را دنبال نکردند. افراد مورد مطالعه سابقه هيچ گونه بيماري تيروئيد، ديابت، صرع، سابقه بيماريهاي زنان و بارداري ( نارسايي دهانه رحم، سابقه نازايي، خونريزي دوران بارداري، جفت سر راه)، كم خوني، مشكلات تنفسي، هرگونه بيماري قلبي عروقي( فشار خون بالا، درد ساق) نداشتند.
    empty
    simple randomized design
    empty
    تصادفی سازی ساده
    empty
    empty
    40 mother-infant pairs
    empty
    40 جفت مادر- طفل
    empty
  • Primary outcomes

    #1
    Communication Skills
    Motor, Cognitive and Communication Skills
    مهارت های ارتباطی
    مهارت های حرکتی، شناختی و ارتباطی
    Ages and Stages III: In this study, Ages and stages Questionnaire III (ASQ 3) was used to evaluate the development rate of Communication skills component in 1 &3 months. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally, 30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.
    Ages and Stages III: In this study, Motor development information of infants were obtained by Peabody Development Motor scale (PDMS-2), and cognitive and social development by Ages and Stages Questionnaire (ASQ III) questionnaire. The Peabody Developmental Motor Scales are used to assess the development of motor skills from birth through 5 years. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally, 30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.
    در این مطالعه، از نسخه سوم پرسشنامه سنین و مراحل (ASQ) برای بررسی میزان رشد مولفه مهارت های ارتباطی طی یک و سه ماهگی استفاده شد. پرسشنامه ASQ، پرسشنامه غربالگر رشدی است که در پنج حیطه رشدی (حرکات درشت، ظریف، برقراری ارتباط، حل مساله و شخصی- اجتماعی) به ارزیابی اطفال پرداخته و وضعیت رشدی را در مقایسه با نقاط برش اعلام می نماید.هر پرسشنامه در بخش اول سوالات جمعیت شناختی را شامل شده و در بخش بعدی، رشد کودک با سوالات و پاسخ های "بله، گاهی اوقات و هنوز نه" مورد ارزیابی قرار می گیرد. زمان مورد نیاز برای پاسخگویی 10 -15 دقیقه برای والدین بود. در مجموع 30 سوال در نظر گرفته شده بود و برای هرسوال بالاترین نمره قابل دریافت 10 و برای هر حیطه 60 بود . این پرسشنامه دارای حساسیت (86/0) و ویژگی (85/0)، پایایی آزمون- باز آزمون قوی با مقدار 75/0 الی 82/0، پایایی بین آزمونگران 93/0 است.
    در این مطالعه، از مقیاس پی بادی برای بررسی مهارت های حرکتی و نسخه سوم پرسشنامه سنین و مراحل (ASQ) برای بررسی میزان رشد مولفه مهارت های شناختی و ارتباطی طی یک و سه ماهگی استفاده شد. مقای پی بادی برای ارزیابی مهارت های حرکتی درشت و ظریف از تولد تا پنج سالگی استفاده می شود.پرسشنامه ASQ، پرسشنامه غربالگر رشدی است که در پنج حیطه رشدی (حرکات درشت، ظریف، برقراری ارتباط، حل مساله و شخصی- اجتماعی) به ارزیابی اطفال پرداخته و وضعیت رشدی را در مقایسه با نقاط برش اعلام می نماید.هر پرسشنامه در بخش اول سوالات جمعیت شناختی را شامل شده و در بخش بعدی، رشد کودک با سوالات و پاسخ های "بله، گاهی اوقات و هنوز نه" مورد ارزیابی قرار می گیرد. زمان مورد نیاز برای پاسخگویی 10 -15 دقیقه برای والدین بود. در مجموع 30 سوال در نظر گرفته شده بود و برای هرسوال بالاترین نمره قابل دریافت 10 و برای هر حیطه 60 بود . این پرسشنامه دارای حساسیت (86/0) و ویژگی (85/0)، پایایی آزمون- باز آزمون قوی با مقدار 75/0 الی 82/0، پایایی بین آزمونگران 93/0 است.
    #2
    Personal- social skills
    Motor, cognitive and Personal- social skills
    مهارت فردی-اجتماعی
    مهارت حرکتی، شناختی و فردی-اجتماعی
    Ages and Stages III: In this study, Ages and stages Questionnaire III (ASQ 3) was used to evaluate the development rate of Personal- Social skills component in 1 &3 months. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally, 30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.
    The Peabody Developmental Motor Scales are used to assess the development of motor skills from birth through 5 years. In this study, the gross motor subscales included reflex, stationary, locomotion and fine motor subscales were grasping, and visual-motor integration were used. Each infant’s raw scores were eventually turned into standard scores and Development Motor Quotient (DMQ) Ages and Stages III: In this study, Ages and stages Questionnaire III (ASQ 3) was used to evaluate the development rate of Personal- Social skills component in 1 &3 months. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally, 30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.
    پرسشنامه سنین و مرحله 3: در این مطالعه، از نسخه سوم پرسشنامه سنین و مراحل (ASQ) برای بررسی میزان رشد مولفه مهارت های فردی- اجتماعی اطفال طی یک و سه ماهگی استفاده شد. پرسشنامه ASQ، پرسشنامه غربالگر رشدی است که در پنج حیطه رشدی (حرکات درشت، ظریف، برقراری ارتباط، حل مساله و شخصی- اجتماعی) به ارزیابی اطفال پرداخته و وضعیت رشدی را در مقایسه با نقاط برش اعلام می نماید.هر پرسشنامه در بخش اول سوالات جمعیت شناختی را شامل شده و در بخش بعدی، رشد کودک با سوالات و پاسخ های "بله، گاهی اوقات و هنوز نه" مورد ارزیابی قرار می گیرد. زمان مورد نیاز برای پاسخگویی 10 -15 دقیقه برای والدین بود. در مجموع 30 سوال در نظر گرفته شده بود و برای هرسوال بالاترین نمره قابل دریافت 10 و برای هر حیطه 60 بود . این پرسشنامه دارای حساسیت (86/0) و ویژگی (85/0)، پایایی آزمون- باز آزمون قوی با مقدار 75/0 الی 82/0، پایایی بین آزمونگران 93/0 است.
    مقیاس پی بادی: برای ارزیابی مهارت های حرکتی تولد تا پنج سالگی مورد استفاده قرار می گیرد. در این مطالعه، مهارت های حرکتی درشت شامل رفلکس ها، جابجایی و وضعیت قامت و مهارت های ظریف شامل چنگ زدن و تعامل بینایی حرکتی بود. و پرسشنامه سنین و مرحله 3: در این مطالعه، از نسخه سوم پرسشنامه سنین و مراحل (ASQ) برای بررسی میزان رشد مولفه مهارت های فردی- اجتماعی اطفال طی یک و سه ماهگی استفاده شد. پرسشنامه ASQ، پرسشنامه غربالگر رشدی است که در پنج حیطه رشدی (حرکات درشت، ظریف، برقراری ارتباط، حل مساله و شخصی- اجتماعی) به ارزیابی اطفال پرداخته و وضعیت رشدی را در مقایسه با نقاط برش اعلام می نماید.هر پرسشنامه در بخش اول سوالات جمعیت شناختی را شامل شده و در بخش بعدی، رشد کودک با سوالات و پاسخ های "بله، گاهی اوقات و هنوز نه" مورد ارزیابی قرار می گیرد. زمان مورد نیاز برای پاسخگویی 10 -15 دقیقه برای والدین بود. در مجموع 30 سوال در نظر گرفته شده بود و برای هرسوال بالاترین نمره قابل دریافت 10 و برای هر حیطه 60 بود . این پرسشنامه دارای حساسیت (86/0) و ویژگی (85/0)، پایایی آزمون- باز آزمون قوی با مقدار 75/0 الی 82/0، پایایی بین آزمونگران 93/0 است.
  • Recruitment centers

    #1
    Name of recruitment center - English: Health Services center, Kamyab
    Name of recruitment center - Persian: مرکز بهداشت و خدمات درمانی شهید کامیاب
    Full name of responsible person - English: Dr Esmaeil Pour
    Full name of responsible person - Persian: دکتر اسماعیل پور
    Street address - English: Emam Khomeini St, Health Services center, Kamyab
    Street address - Persian: خ امام خمینی، مرکز بهداشتی شهید کامیاب
    City - English: Bojnourd
    City - Persian: بجنورد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Health Services center, Kamyab
    Name of recruitment center - Persian: مرکز بهداشت و خدمات درمانی شهید کامیاب
    Full name of responsible person - English: Dr Esmaeil Pour
    Full name of responsible person - Persian: دکتر اسماعیل پور
    Street address - English: Emam Khomeini St, Health Services center, Kamyab
    Street address - Persian: خ امام خمینی، مرکز بهداشتی شهید کامیاب
    City - English: بجنورد
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9413913611
    Phone: +98 58 3222 1594
    Fax:
    Email: nshojaeian@yahoo.com
    Web page address:
    #2
    Name of recruitment center - English: Bentolhada Hospital
    Name of recruitment center - Persian: بیمارستان بنت الهدی
    Full name of responsible person - English: Dr Mafi Nejad
    Full name of responsible person - Persian: دکتر مافی نژاد
    Street address - English: Zayeshgah St, medical science university of Bojnourd, Bentolhada Hospital
    Street address - Persian: خ زایشگاه، دانشگاه علوم پزشکی بجنورد، بیمارستان بنت الهدی
    City - English: Bojnourd
    City - Persian: بجنورد
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Bentolhada Hospital
    Name of recruitment center - Persian: بیمارستان بنت الهدی
    Full name of responsible person - English: Dr Mafi Nejad
    Full name of responsible person - Persian: دکتر مافی نژاد
    Street address - English: Zayeshgah St, medical science university of Bojnourd, Bentolhada Hospital
    Street address - Persian: خ زایشگاه، دانشگاه علوم پزشکی بجنورد، بیمارستان بنت الهدی
    City - English: Bojnourd
    City - Persian: بجنورد
    Province: North Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9413913611
    Phone: +98 58 3222 1594
    Fax:
    Email: nshojaeian@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Science and Research University of Tehran
    Name of organization / entity - Persian: دانشگاه علوم و تحقیقات تهران
    Full name of responsible person - English: Dr. Mohammad Hossein Modaresi
    Full name of responsible person - Persian: دکتر محمد حسین مدرسی
    Street address - English: Hessarak BLV, Science and research University
    Street address - Persian: بلوار حصارک، دانشگاه علوم و تحقیقات
    City - English: Tehran
    City - Persian: تهران
    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. Mohammad Hossein Modaresi
    Full name of responsible person - Persian: دکتر محمد حسین مدرسی
    Street address - English: Hessarak BLV, Science and research University
    Street address - Persian: بلوار حصارک، دانشگاه علوم و تحقیقات
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: ۱۴۷۷۸۹۳۸۵۵
    Phone: +98 21 4486 5179
    Fax:
    Email: nshojaeian@yahoo.com
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Science and Research University of Tehran
    Islamic Azad University
    دانشگاه علوم و تحقیقات تهران
    دانشگاه آزا د اسلامی
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University, Bojnourd branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد بجنورد
    Full name of responsible person - English: Najmeh-Alsadat Shojaeian
    Full name of responsible person - Persian: نجمه السادات شجاعیان
    Position - English: Motor Development Assistant
    Position - Persian: استادیار رشد حرکتی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Islamic Azad University, Bojnourd branch, Daneshgah blvd.
    Street address - Persian: کوی دانشگاه
    City - English: Bojnourd
    City - Persian: بجنورد
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 58 3229 6982
    Mobile:
    Fax:
    Email: nshojaeian@yahoo.com; shojaeian@bojnourdiau.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Najmeh-Alsadat Shojaeian
    Full name of responsible person - Persian: نجمه السادات شجاعیان
    Position - English: Motor Development Assistant
    Position - Persian: استادیار رشد حرکتی
    Latest degree: phd
    Area of specialty/work: 88
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Islamic Azad University, Bojnourd branch, Daneshgah blvd.
    Street address - Persian: کوی دانشگاه
    City - English: Bojnourd
    City - Persian: بجنورد
    Province: North Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9413913611
    Phone: +98 58 3229 6982
    Mobile: +98 903 177 0054
    Fax:
    Email: shojaeian@bojnourdiau.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Alzahra University
    Name of organization / entity - Persian: دانشگاه الزهرا
    Full name of responsible person - English: Masoumeh Shojaei
    Full name of responsible person - Persian: معصومه شجاعی
    Position - English: Associate Prof., Motor Behavior
    Position - Persian: دانشیار رفتار حرکتی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Alzahra Universityو Deh Vanak
    Street address - Persian: ده ونک، دانشگاه الزهرا
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 8804 1468
    Mobile:
    Fax:
    Email: nshojaeian@yahoo.com; m.shojae@alzahra.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Alzahra University
    Name of organization / entity - Persian: دانشگاه الزهرا
    Full name of responsible person - English: Masoumeh Shojaei
    Full name of responsible person - Persian: معصومه شجاعی
    Position - English: Associate Prof., Motor Behavior
    Position - Persian: دانشیار رفتار حرکتی
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English: motor behavior
    Area of specialty/work title - Persian: رفتار حرکتی
    Street address - English: Alzahra Universityو Deh Vanak
    Street address - Persian: ده ونک، دانشگاه الزهرا
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 9413913611
    Phone: +98 21 8804 1468
    Mobile: +98 903 177 0054
    Fax:
    Email: m.shojae@alzahra.ac.ir
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Islamic Azad Uinversity, science and research branch of Tehran
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد علوم و تحقیقات تهران
    Full name of responsible person - English: Najmeh- Alsadat Shojaeian
    Full name of responsible person - Persian: نجمه السادات شجاعیان
    Position - English: Motor Development Ph.D
    Position - Persian: دکتری رشد حرکتی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Hessarak BLV, Science and Research Uinversity
    Street address - Persian: حصارک، دانشگاه علوم و تحقیقات
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1477893855
    Phone: +98 21 4486 5179
    Mobile:
    Fax:
    Email: nshojaeian@yahoo.com; shojaeian@bojnourdiau.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Islamic Azad Uinversity, science and research branch of Tehran
    Name of organization / entity - Persian: دانشگاه آزاد اسلامی واحد علوم و تحقیقات تهران
    Full name of responsible person - English: Najmeh- Alsadat Shojaeian
    Full name of responsible person - Persian: نجمه السادات شجاعیان
    Position - English: Motor Development Ph.D
    Position - Persian: دکتری رشد حرکتی
    Latest degree: phd
    Area of specialty/work: 0
    Area of specialty/work title - English: Motor Development
    Area of specialty/work title - Persian: رشد حرکتی
    Street address - English: Hessarak BLV, Science and Research Uinversity
    Street address - Persian: حصارک، دانشگاه علوم و تحقیقات
    City - English: Tehran
    City - Persian: تهران
    Province: North Khorasan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1477893855
    Phone: +98 21 4486 5179
    Mobile: +98 903 177 0054
    Fax:
    Email: shojaeian@bojnourdiau.ac.ir
    Web page address:
  • Sharing plan

    yes
    yes
    yes
    yes
    yes
    yes
    yes
    empty
    to present the data through articles
    empty
    ارایه داده ها در قالب مقاله
    empty
    one year later
    empty
    یک سال آینده
    empty
    all people
    empty
    همه افراد
    empty
    to share data
    empty
    اشتراک گذاری داده ها
    empty
    Journals
    empty
    مجلات
    empty
    send- referring- publish
    empty
    ارسال -داوری- چاپ

Protocol summary

Study aim
The aim of this study was to examine the effects of maternal prenatal selected activities on cognitive, motor, and social development of infants.
Design
Using the G-power software, the sample size was determined and the women in the study were randomly assigned into two experimental (n=20) and control (n=20) groups. According to the considered criteria, the sample size was reduced to 36 pairs (10%).
Settings and conduct
Participants were pregnant women visiting healthcare centers of Bojnourd in 2016-17. In this project, 40 mother-child pairs were evaluated. The participants were recruited by contacting midwives, family education centers or families.
Participants/Inclusion and exclusion criteria
pregnant women
Intervention groups
data were gathered from 40 mother-neonate pairs who were selected from healthcare centers and hospitals (2016-2017) and their infants were evaluated for gross and fine motor skills, cognitive and social skills at ages of 1 and 3 months (final N=36). Pregnant mothers were active in the second and third trimesters. In control group, mothers received the normal medical care.
Main outcome variables
The data from infants were collected in motor, cognitive and social domains during 1 and 3 months of age.

General information

Reason for update
to complete the data
Acronym
IRCT registration information
IRCT registration number: IRCT2017050133743N1
Registration date: 2017-05-31, 1396/03/10
Registration timing: retrospective

Last update: 2019-11-30, 1398/09/09
Update count: 2
Registration date
2017-05-31, 1396/03/10
Registrant information
Name
Najmeh Alsadat Shojaeian
Name of organization / entity
Azad University of Bojnourd
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 1594
Email address
shojaeian@bojnourdiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Science and research University of Tehran
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants
Public title
Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The inclusion criteria for the study were: all nulliparous pregnant women; non-athletes and house wives who admitted to city hospitals and prenatal care centers of Bojnurd. They had a gestational age of 23 to 34 weeks and according to their health records, body mass index (BMI) before pregnancy (20 to 24.9 kilograms per square meter) was normal. Similarly they had a normal singleton pregnancy at term (37-41 weeks) with the birth of a healthy baby (without any apparent anomalies). The subjects had no previous history of any underlying disease and were controlled based on their medical records.
Exclusion criteria:
Age
From 22 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomized design
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
Islamic Azad University, science and research branch, Tehran
Street address
Sattari highway, Hesarak blvd.
City
بجنورد
Province
North Khorasan
Postal code
۱۴۷۷۸۹۳۸۵۵
Approval date
2016-01-02, 1394/10/12
Ethics committee reference number
15/62125

2

Ethics committee
Name of ethics committee
North Khorasan University of Medical Sciences and Health Services
Street address
South Shariatti St., Karimi Rad Alley
City
Bojnourd
Province
North Khorasan
Postal code
9413913611
Approval date
2016-02-01, 1394/11/12
Ethics committee reference number
94/60/1883

Health conditions studied

1

Description of health condition studied
Normal pregnancy
ICD-10 code
Z34
ICD-10 code description
Supervision of normal pregnancy

Primary outcomes

1

Description
Motor, Cognitive and Communication Skills
Timepoint
1 and 3 months after delivery
Method of measurement
Ages and Stages III: In this study, Motor development information of infants were obtained by Peabody Development Motor scale (PDMS-2), and cognitive and social development by Ages and Stages Questionnaire (ASQ III) questionnaire. The Peabody Developmental Motor Scales are used to assess the development of motor skills from birth through 5 years. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally, 30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.

2

Description
Motor, cognitive and Personal- social skills
Timepoint
1 and 3 months after delivery
Method of measurement
The Peabody Developmental Motor Scales are used to assess the development of motor skills from birth through 5 years. In this study, the gross motor subscales included reflex, stationary, locomotion and fine motor subscales were grasping, and visual-motor integration were used. Each infant’s raw scores were eventually turned into standard scores and Development Motor Quotient (DMQ) Ages and Stages III: In this study, Ages and stages Questionnaire III (ASQ 3) was used to evaluate the development rate of Personal- Social skills component in 1 &3 months. The ASQ Questionnaire is the screening questionnaire of development in five areas of development (gross motor, fine motor, communication, problem solving, and social personal) to assess infants and declares developmental situation compared to the cut-off points. The questionnaire included demographic questions in the first section and in the next section, child development be evaluated with questions and answers "Yes, sometimes, and yet not". The time required to meet 10 -15 minutes for the parents. Totally, 30 questions was intended and for each question, highest score was 10 and 60 for each area. ASQ-3 is reliable and valid. ASQ-3 has excellent sensitivity (0.86) and specificity (0.85) that has adequate accuracy for screening. Strong test-retest reliability of 0.75 to 0.82, inter-rater reliability by comparing the filled-in forms to parents and professional examiners was 0.93.

Secondary outcomes

empty

Intervention groups

1

Description
After receiving consent, the experimental group participated from the end of twenty-third week of pregnancy in an intervention period of about 8 weeks with 16 sessions of activity. The activity time was 50 minutes and it was consisted of two parts. The first part includes a 5 minute warm-up, specialized training, such as walking at moderate intensity (60-75 percent of maximum heart rate), massage, relaxation, and 5 minutes of cooling down. In the first part of training time from 25 minutes rose to 40 minutes in the last week. In the second part 10 minutes of teaching breathing skills and correctly position were taught to them. The selected movements were carried out with the approval of a gynecologist and obstetrician monitoring.
Category
Lifestyle

2

Description
The pregnant women in control group were selected randomly and received usual care during pregnancy. They were not banned from physical activity, but base on their report, they did not follow regular physical activity.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Services center, Kamyab
Full name of responsible person
Dr Esmaeil Pour
Street address
Emam Khomeini St, Health Services center, Kamyab
City
بجنورد
Province
North Khorasan
Postal code
9413913611
Phone
+98 58 3222 1594
Email
nshojaeian@yahoo.com

2

Recruitment center
Name of recruitment center
Bentolhada Hospital
Full name of responsible person
Dr Mafi Nejad
Street address
Zayeshgah St, medical science university of Bojnourd, Bentolhada Hospital
City
Bojnourd
Province
North Khorasan
Postal code
9413913611
Phone
+98 58 3222 1594
Email
nshojaeian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mohammad Hossein Modaresi
Street address
Hessarak BLV, Science and research University
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
nshojaeian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Najmeh-Alsadat Shojaeian
Position
Motor Development Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Islamic Azad University, Bojnourd branch, Daneshgah blvd.
City
Bojnourd
Province
North Khorasan
Postal code
9413913611
Phone
+98 58 3229 6982
Fax
Email
shojaeian@bojnourdiau.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Masoumeh Shojaei
Position
Associate Prof., Motor Behavior
Latest degree
Ph.D.
Other areas of specialty/work
motor behavior
Street address
Alzahra Universityو Deh Vanak
City
Tehran
Province
Tehran
Postal code
9413913611
Phone
+98 21 8804 1468
Fax
Email
m.shojae@alzahra.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad Uinversity, science and research branch of Tehran
Full name of responsible person
Najmeh- Alsadat Shojaeian
Position
Motor Development Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Motor Development
Street address
Hessarak BLV, Science and Research Uinversity
City
Tehran
Province
North Khorasan
Postal code
1477893855
Phone
+98 21 4486 5179
Fax
Email
shojaeian@bojnourdiau.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
to present the data through articles
When the data will become available and for how long
one year later
To whom data/document is available
all people
Under which criteria data/document could be used
to share data
From where data/document is obtainable
Journals
What processes are involved for a request to access data/document
send- referring- publish
Comments
Loading...