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General information
2015-03-20, 1393/12/29
2016-07-20, 1395/04/30
20152016-0307-20 00:00:00
2016-03-19, 1394/12/29
2017-03-19, 1395/12/29
20162017-03-19 00:00:00
simple randomized design
it allocated participants 1:1 to the experimental (n=20) or the control group (n=20), using a computer random number generator.
simple randomized designit allocated participants 1:1 to the experimental (n=20) or the control group (n=20), using a computer random number generator.
تصادفی سازی ساده
شرکت کنندگان 1: 1 را با استفاده از تولید کننده شماره تصادفی رایانه به گروه آزمایش (20 نفر) یا گروه کنترل (20 نفر) اختصاص داد.
شرکت کنندگان 1: 1 را با استفاده از تولید کننده شماره تصادفی سازی سادهرایانه به گروه آزمایش (20 نفر) یا گروه کنترل (20 نفر) اختصاص داد.
Sponsors / Funding sources
#1
Islamic Azad University
Islamic Azad University
Islamic Azad University
دانشگاه آزا د اسلامی
دانشگاه آزاد اسلامی
دانشگاه آزا دآزاد اسلامی
Trial results
No
Yes
1
empty
2020-04-15, 1399/01/27
2020-04-15 14:43:44
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:2020-04-15, 1399/01/27
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
2016-07-20, 1395/04/30
Expected recruitment end date
2017-03-19, 1395/12/29
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
it allocated participants 1:1 to the experimental (n=20) or the control group (n=20), using a computer random number generator.
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