Healthy Children and Their ParentsNCT04300634
Encouraging Physical Activity: Action Or Direction?
An observational study of Healthy Children and Their Parents, run by Istanbul University - Cerrahpasa.
Trial summary
Children's physical activity level is decreasing globally. Habits acquired in childhood and adolescence tend to continue in adulthood. Therefore, to obtain individuals who do physical activity or sports, this habit should be gained in childhood. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children and Their Parents
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2020to 16 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between 9-14 years of age, who have similar physical activity awareness, athletes and physiotherapist parents.
Who may be able to join
- Being between the ages of 9-14
- Being literate in Turkish
- Not having any physical disability preventing them from doing physical activities
- Attending physical education class regularly
Who cannot join
- Having a serious cognitive impairment
- Going to school on foot
- Physiotherapists to be selected for the physiotherapist group to work in the field of sports
About this study
Children's physical activity level is decreasing globally. Habits acquired in childhood and adolescence tend to continue in adulthood. Therefore, to obtain individuals who do physical activity or sports, this habit should be gained in childhood.
It is necessary to understand the factors affecting children's lives to increase the physical activity level of the children and make the active lifestyle a habit. These factors can be divided into the environment and family. It is the place where the family socialization process begins first and social norms and cultural values are learned. Parents can be more effective than the environment because they are the main decision-makers on the child. Parents configure the child's time, duties, provide the sports equipment to their child, transfer them for activity. They can support an active lifestyle by taking role models by children. Role modeling is defined as the child's behaviors of observation and social learning and their parents' behavior. In a review, it has been reported that physically active parents encourage their children to have more activities and may have active children. Small-group studies using an objective method are limited in terms of generalizability. While determining the activity level of the child and the family, the fact that the families can respond biased for their children and that the mother or father can take a role model according to the gender of the child reduces the quality of the studies. It remains unclear how and to what extent parents affect children's activity levels.
The aim of this study is to compare the physical activity level of children between 9-14 years of age, who have similar physical activity awareness, athletes and physiotherapist parents
- Conditions
- Healthy Children and Their Parents
- Keywords
- physical activity, active children, active parents
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children whose parents are physiotherapists | The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. | |
| Children whose parents are athletes | The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. | |
| Parents of children who are atletes | The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. | |
| Parents of children who are physiotherapist | The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Questionnaire for Older Children (PAQ-C)
Physical Activity Questionnaire for Older Children, developed in 2004 by Kowalski et al., is one of the frequently used scales for evaluating children's physical activities. The survey consists of 10 items and the first 9 items are used to calculate activity scores. The 10th item evaluates whether the child participated in the activity in the previous week, depending on the disease or other condition. While the minimum total score is 9, the maximum score is 45. The higher scores indicate that there is more physical activity and the lower scores indicate less physical activity.
Measured: 4 weeks
Physical Activity Diary
A physical activity diary is frequently used in Turkish validity and reliability studies of physical activity surveys. In our study, Physical Activity Diary will be used for children and parents. The activities of the children will be evaluated in the morning, noon and evening for each day for 1 week. The children are asked to fill in the 'sitting, walking, running, jumping, doing sports and being active' activities for each of the morning, lunch and evening slices. It should be noted that the diary can be filled in hours or minutes. Parents' seating, walking, and sports activities are questioned weekly, within and outside the workplace.
Measured: 4 weeks
Secondary outcomes (1)
The International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) was developed to provide a common tool that can be used to obtain internationally comparable data in determining health-related physical activity. The questionnaire, whose short form is widely used, consists of 4 parts. According to IPAQ, individuals spend "8.0 MET" in "severe physical activities", "4.0 MET in moderate physical activities, and 3.3 MET in" walking ". Scoring is done by multiplying the number of minutes and days of activity with the respective MET values. The total MET value is obtained by adding the scores of the subtitles. The total value is called physical activity value. According to the total score, less than 600 weekly MET values are evaluated as low-level physical activity, between 601-3.000 MET are medium level and more than 3,000 MET are high-level physical activity.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start16 Mar 2020 (estimated)
- Primary completion16 May 2020 (estimated)
- Study completion16 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Children and Their ParentsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Avcıl, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300634
- Sponsor's protocol ID
- 001
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 9 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encouraging Physical Activity: Action Or Direction?
- ClinicalTrials.gov ID
- NCT04300634
- Acronym / sponsor ID
- 001
- Conditions
- Healthy Children and Their Parents
- Keywords
- physical activity, active children, active parents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 16 Mar 2020 (estimated)
- Primary completion
- 16 May 2020 (estimated)
- Study completion
- 16 Jun 2020 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children's physical activity level is decreasing globally. Habits acquired in childhood and adolescence tend to continue in adulthood. Therefore, to obtain individuals who do physical activity or sports, this habit should be gained in childhood.
It is necessary to understand the factors affecting children's lives to increase the physical activity level of the children and make the active lifestyle a habit. These factors can be divided into the environment and family. It is the place where the family socialization process begins first and social norms and cultural values are learned. Parents can be more effective than the environment because they are the main decision-makers on the child. Parents configure the child's time, duties, provide the sports equipment to their child, transfer them for activity. They can support an active lifestyle by taking role models by children. Role modeling is defined as the child's behaviors of observation and social learning and their parents' behavior. In a review, it has been reported that physically active parents encourage their children to have more activities and may have active children. Small-group studies using an objective method are limited in terms of generalizability. While determining the activity level of the child and the family, the fact that the families can respond biased for their children and that the mother or father can take a role model according to the gender of the child reduces the quality of the studies. It remains unclear how and to what extent parents affect children's activity levels.
The aim of this study is to compare the physical activity level of children between 9-14 years of age, who have similar physical activity awareness, athletes and physiotherapist parents
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children whose parents are physiotherapists | – | –The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. |
| Children whose parents are athletes | – | –The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. |
| Parents of children who are atletes | – | –The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. |
| Parents of children who are physiotherapist | – | –The demographic data of the child and the parent whom he/she played a role in will be recorded. The physical activity habits of the child and the parent, the sports areas he/she is interested in and the level of activity will be questioned. Physical Activity Questionnaire for Older Children (PAQ-C) and the Physical Activity Diary will be used to assess children's physical activity level. Parameters such as physical activity status, participation in a regular sports activity, daily average time spent with activity at school and during breaks, daily time allocated to the activity will be evaluated. The International Physical Activity Questionnaire (IPAQ) and Physical Activity Diary will be used to evaluate the level of physical activity of the parents. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between 9-14 years of age, who have similar physical activity awareness, athletes and physiotherapist parents.
Key inclusion criteria (4 listed)
- Being between the ages of 9-14
- Being literate in Turkish
- Not having any physical disability preventing them from doing physical activities
- Attending physical education class regularly
Key exclusion criteria (3 listed)
- Having a serious cognitive impairment
- Going to school on foot
- Physiotherapists to be selected for the physiotherapist group to work in the field of sports
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physical Activity Questionnaire for Older Children (PAQ-C)
Time frame: 4 weeks
Physical Activity Questionnaire for Older Children, developed in 2004 by Kowalski et al., is one of the frequently used scales for evaluating children's physical activities. The survey consists of 10 items and the first 9 items are used to calculate activity scores. The 10th item evaluates whether the child participated in the activity in the previous week, depending on the disease or other condition. While the minimum total score is 9, the maximum score is 45. The higher scores indicate that there is more physical activity and the lower scores indicate less physical activity.
Physical Activity Diary
Time frame: 4 weeks
A physical activity diary is frequently used in Turkish validity and reliability studies of physical activity surveys. In our study, Physical Activity Diary will be used for children and parents. The activities of the children will be evaluated in the morning, noon and evening for each day for 1 week. The children are asked to fill in the 'sitting, walking, running, jumping, doing sports and being active' activities for each of the morning, lunch and evening slices. It should be noted that the diary can be filled in hours or minutes. Parents' seating, walking, and sports activities are questioned weekly, within and outside the workplace.
1 secondary outcome
The International Physical Activity Questionnaire (IPAQ)
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Children and Their Parents, run by Istanbul University - Cerrahpasa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Questionnaire for Older Children (PAQ-C) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.