Protocol summary
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Study aim
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The aim of this study was to examine the effects of maternal prenatal selected activities on cognitive, motor, and social development of infants.
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Design
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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%).
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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pregnant women
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Intervention groups
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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.
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Main outcome variables
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The data from infants were collected in motor, cognitive and social domains during 1 and 3 months of age.
General information
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Reason for update
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to complete the data
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Acronym
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IRCT registration information
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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
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Registration date
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2017-05-31, 1396/03/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice Chancellor for Research of Science and research University of Tehran
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Expected recruitment start date
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2016-07-20, 1395/04/30
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Expected recruitment end date
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2017-03-19, 1395/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants
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Public title
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Effect of physical activity during pregnancy on development of Motor, Cognitive and Social skills in infants
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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:
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Age
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From 22 years old to 30 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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it allocated participants 1:1 to the experimental (n=20) or the control group (n=20), using a computer random number generator.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-01-02, 1394/10/12
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Ethics committee reference number
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15/62125
2
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Ethics committee
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Approval date
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2016-02-01, 1394/11/12
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Ethics committee reference number
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94/60/1883
Health conditions studied
1
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Description of health condition studied
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Normal pregnancy
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ICD-10 code
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Z34
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ICD-10 code description
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Supervision of normal pregnancy
Primary outcomes
1
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Description
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Motor, Cognitive and Communication Skills
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Timepoint
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1 and 3 months after delivery
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Method of measurement
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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
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Description
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Motor, cognitive and Personal- social skills
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Timepoint
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1 and 3 months after delivery
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Method of measurement
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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.
Intervention groups
1
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Description
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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.
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Category
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Lifestyle
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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to present the data through articles
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When the data will become available and for how long
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one year later
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To whom data/document is available
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all people
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Under which criteria data/document could be used
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to share data
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From where data/document is obtainable
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Journals
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What processes are involved for a request to access data/document
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send- referring- publish
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Comments
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Trial results
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Please tick if results have been published
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Yes
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Summary result posting date
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2020-04-15, 1399/01/27
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Table of baseline comparison
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Participant flow diagram
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Table of variable outcomes' results
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Table of adverse events
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First publication date
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empty
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Abstract of published paper
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