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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050133743N1
Registration date:2017-05-31, 1396/03/10
Registration timing:retrospective
Last update:
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 Social skills in infants
Public title
Effect of physical activity during pregnancy on development of Social skills in infants
Purpose
Supportive
Inclusion/Exclusion 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. If there was any contraindication to participate in the exercise by the individual practitioner like bleeding during pregnancy, not want to participate in the interventions and not participate in 80% of training sessions, they were excluded from the study. Similarly, premature birth and infant in NICU hospitalization led to their withdrawal from the study.
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
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
Tehran
Postal code
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
Postal code
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
Communication Skills
Timepoint
1 and 3 months after delivery
Method of measurement
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.
2
Description
Personal- social skills
Timepoint
1 and 3 months after delivery
Method of measurement
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
Bojnourd
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
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Science and Research University of Tehran
Full name of responsible person
Dr. Mohammad Hossein Modaresi
Street address
Hessarak BLV, Science and research University
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Science and Research University of Tehran
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, Bojnourd branch
Full name of responsible person
Najmeh-Alsadat Shojaeian
Position
Motor Development Assistant
Other areas of specialty/work
Street address
Islamic Azad University, Bojnourd branch, Daneshgah blvd.
City
Bojnourd
Postal code
Phone
+98 58 3229 6982
Fax
Email
nshojaeian@yahoo.com; 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
Other areas of specialty/work
Street address
Alzahra Universityو Deh Vanak
City
Tehran
Postal code
Phone
+98 21 8804 1468
Fax
Email
nshojaeian@yahoo.com; 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
Other areas of specialty/work
Street address
Hessarak BLV, Science and Research Uinversity
City
Tehran
Postal code
1477893855
Phone
+98 21 4486 5179
Fax
Email
nshojaeian@yahoo.com; shojaeian@bojnourdiau.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)