School Based InterventionNCT04487132
Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents
A study testing Active physical education lessons and physical education plan and Recess or lunch time activities in people with School Based Intervention, run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
This study examines the effect of self designed school-based interventions on physical activity and psychological outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept, and academic achievement among a community sample of adolescents from Taxila, Pakistan Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- School Based Intervention
- What is being tested?
- Active physical education lessons and physical education plan and Recess or lunch time activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2020to 30 Dec 2020
- Phase
- Interventional
- 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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants from grade 6th to 8th with in age range of 10-15 years.
- Participants who have lack of physical activity.
- Participants who provide consent to take part in the intervention.
Who cannot join
- Those participants who do not provide consent to take part in intervention will not be eligible take part in intervention.
- Participants who are having any physical disability or medical condition that compromises their mobility will not take part in intervention.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Fatima Jinnah Women University Ethics Review Board
Rawalpindi, Punjab Province
Sajida Naz, Dr, 0332-9370378, dr.sajida@fjwu.edu.pk
About this study
Official title: Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents: A Randomized Control Trial
This study examines the effect of self designed school-based interventions on physical activity and psychological outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept, and academic achievement among a community sample of adolescents from Taxila, Pakistan
Read the detailed description
The main objective of this study is to assess the level of motivation towards physical activity and psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and academic achievement as assessed through recent grade) among young adolescents and to develop intervention to enhance motivation towards physical activity among young adolescents. Randomized Control Trial design will be used in this study to examine the impact of school-based intervention on motivation towards physical activity and psychosocial outcomes. After assessing their motivation toward physical activity and psychosocial outcomes intervention will given for 10 weeks, in which participants will be asked to participate in 10 minutes exercise activity on regular basis from Monday to Friday during school timings. Assessment will be done to find out that whether the school based intervention will be effective for them in motivation towards physical activity and reduction psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and academic achievement (as assessed through recent grade)) among adolescents or not. This results of this study will be used in promoting active lifestyle may help the adolescent to develop long-term positive healthy habits and targeting adolescents through encouraging physical activity in school or educational setting and social surrounding. To make decision about effective programs and policies to promote physical activity should be taken in account, by providing empirical support for public health messages that encourage participation in school spots as a mean to reduce the burden of poor mental health. Physical activity programming must align with the predictable developmental changes in adolescent exercise capacity and motor skills, which affect the activities in which they can successfully engage. These programs specifically designed to improve psychosocial outcomes, such as self-concept, social behavior and self-efficacy of adolescents as these are the most important determinants of participation in physical activities.
- Conditions
- School Based Intervention
- Being tested
- Active physical education lessons and physical education plan, Recess or lunch time activities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active physical education lessons and physical education planBehavioural
Also called physical education plan
Active physical education lessons and physical education plan Including importance of physical activity and health, and physical education plan; through lecture in classroom will be provided to the contyrolled group.
Recess or lunch time activitiesBehavioural
Also called physical activities group intervention
group intervention will be provided ti the experimental group which includes Preparing the playground by offering adequate spaces and games.Developing games and teaching children to play in recess time at-least 10-15 minutes daily(i.e.sport games, traditional games) Placing a sheet in the classroom with some reminders about being active in recess time (i.e. using a poster board encouraging playing one of the selected games )
| Study group | Role | What they receive |
|---|---|---|
| Active physical education lessons and physical education plan | Active comparator | Active physical education lessons and physical education plan provided to the controlled group Receives: Behavioral: Active physical education lessons and physical education plan |
| Recess or lunch time activities | Active comparator | Preparing the playground by offering adequate spaces and games provided to the experimental group Receives: Behavioral: Active physical education lessons and physical education plan; Behavioral: Recess or lunch time activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation towards Physical Activity
the level of motivation towards physical activity will be assessed by the Participation Motivation Questionnaire.Participation Motivation Questionnaire is 3 point likert scale 1 for very important and 3 for not at all important.The Participation Motivation Questionnaire will revealed the factors of achievement/status, team atmosphere, fitness, energy release, skill development, friend- ship and fun as basic motives for involvement .
Measured: 1 month
Level of Physical Activity
The Level of Physical Activity will be assessed through through using the physical activity questionnaire- adolescents (PAQ-A) is a self-administered, 7-day recall instrument , each scored on a 5-point scale. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Measured: 1 month
Psychosocial Outcomes
Psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms) will be assessed through Adolescents Behavioural Checklist is four point likert scale where o for Not at all and 3 for very much. Adolescents Behavioural Checklist consists of 48 items, 42 of which yield a total ABC score and six factor scores (Conduct Problems, Impulsivity/Hyperactivity, Poor Work Habits, Inattention, Emotional Liability, Social Problems).
Measured: 1 month
Self Concept
Self-Concept will be assessed through using Self Concept Questionnaire .t consist of 48 items which provides 6 separate dimensions of self-concept (e.g physical, social, intellectual, moral, educational and temperamental) ,each item have 5 response.
Measured: 1 month
Academic Achievement
Academic Achievement will be assess through recent academic achievement or performance in exams
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start10 Jul 2020
- Primary completion10 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for School Based InterventionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial design will be used in this study to examine the impact of school-based intervention on motivation towards physical activity and psychosocial outcomes among adolescents. In trials with randomized and controlled design the effects of the study (school based intervention and psychosocial outcomes) are compared with those of a control group and the participants are randomly assigned to the two groups. In this interventional model Active physical education lessons and physical education plan will be carried out which includes, Physical activities 10 -15 minutes daily or at least 5 days in a week during the school timings.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anmol Ayaz, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487132
- Sponsor's protocol ID
- FJWU/Reg/2020
- Status last verified
- Dec 2020
- First submitted
- 10 Jul 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04487132
- Acronym / sponsor ID
- FJWU/Reg/2020
- Conditions
- School Based Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 10 Jul 2020 (actual)
- Primary completion
- 10 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 27 Jul 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.
This study examines the effect of self designed school-based interventions on physical activity and psychological outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept, and academic achievement among a community sample of adolescents from Taxila, Pakistan
Detailed description
The main objective of this study is to assess the level of motivation towards physical activity and psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and academic achievement as assessed through recent grade) among young adolescents and to develop intervention to enhance motivation towards physical activity among young adolescents. Randomized Control Trial design will be used in this study to examine the impact of school-based intervention on motivation towards physical activity and psychosocial outcomes. After assessing their motivation toward physical activity and psychosocial outcomes intervention will given for 10 weeks, in which participants will be asked to participate in 10 minutes exercise activity on regular basis from Monday to Friday during school timings. Assessment will be done to find out that whether the school based intervention will be effective for them in motivation towards physical activity and reduction psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms, self-concept and academic achievement (as assessed through recent grade)) among adolescents or not. This results of this study will be used in promoting active lifestyle may help the adolescent to develop long-term positive healthy habits and targeting adolescents through encouraging physical activity in school or educational setting and social surrounding. To make decision about effective programs and policies to promote physical activity should be taken in account, by providing empirical support for public health messages that encourage participation in school spots as a mean to reduce the burden of poor mental health. Physical activity programming must align with the predictable developmental changes in adolescent exercise capacity and motor skills, which affect the activities in which they can successfully engage. These programs specifically designed to improve psychosocial outcomes, such as self-concept, social behavior and self-efficacy of adolescents as these are the most important determinants of participation in physical activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial design will be used in this study to examine the impact of school-based intervention on motivation towards physical activity and psychosocial outcomes among adolescents. In trials with randomized and controlled design the effects of the study (school based intervention and psychosocial outcomes) are compared with those of a control group and the participants are randomly assigned to the two groups. In this interventional model Active physical education lessons and physical education plan will be carried out which includes, Physical activities 10 -15 minutes daily or at least 5 days in a week during the school timings.
| Arm | Type | Receives |
|---|---|---|
| Active physical education lessons and physical education plan | Active comparator | Behavioral: Active physical education lessons and physical education planActive physical education lessons and physical education plan provided to the controlled group |
| Recess or lunch time activities | Active comparator | Behavioral: Active physical education lessons and physical education plan, Behavioral: Recess or lunch time activitiesPreparing the playground by offering adequate spaces and games provided to the experimental group |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants from grade 6th to 8th with in age range of 10-15 years.
- Participants who have lack of physical activity.
- Participants who provide consent to take part in the intervention.
Key exclusion criteria (2 listed)
- Those participants who do not provide consent to take part in intervention will not be eligible take part in intervention.
- Participants who are having any physical disability or medical condition that compromises their mobility will not take part in intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active physical education lessons and physical education planAlso: physical education planActive physical education lessons and physical education plan Including importance of physical activity and health, and physical education plan; through lecture in classroom will be provided to the contyrolled group. | Behavioural | Active physical education lessons and physical education plan, Recess or lunch time activities |
| Recess or lunch time activitiesAlso: physical activities group interventiongroup intervention will be provided ti the experimental group which includes Preparing the playground by offering adequate spaces and games.Developing games and teaching children to play in recess time at-least 10-15 minutes daily(i.e.sport games, traditional games) Placing a sheet in the classroom with some reminders about being active in recess time (i.e. using a poster board encouraging playing one of the selected games ) | Behavioural | Recess or lunch time activities |
Primary outcome
Motivation towards Physical Activity
Time frame: 1 month
the level of motivation towards physical activity will be assessed by the Participation Motivation Questionnaire.Participation Motivation Questionnaire is 3 point likert scale 1 for very important and 3 for not at all important.The Participation Motivation Questionnaire will revealed the factors of achievement/status, team atmosphere, fitness, energy release, skill development, friend- ship and fun as basic motives for involvement .
Level of Physical Activity
Time frame: 1 month
The Level of Physical Activity will be assessed through through using the physical activity questionnaire- adolescents (PAQ-A) is a self-administered, 7-day recall instrument , each scored on a 5-point scale. A score of 1 indicates low physical activity, whereas a score of 5 indicates high physical activity.
Psychosocial Outcomes
Time frame: 1 month
Psychosocial outcomes (i.e., internalizing and externalizing behavioral symptoms) will be assessed through Adolescents Behavioural Checklist is four point likert scale where o for Not at all and 3 for very much. Adolescents Behavioural Checklist consists of 48 items, 42 of which yield a total ABC score and six factor scores (Conduct Problems, Impulsivity/Hyperactivity, Poor Work Habits, Inattention, Emotional Liability, Social Problems).
Self Concept
Time frame: 1 month
Self-Concept will be assessed through using Self Concept Questionnaire .t consist of 48 items which provides 6 separate dimensions of self-concept (e.g physical, social, intellectual, moral, educational and temperamental) ,each item have 5 response.
Academic Achievement
Time frame: 1 month
Academic Achievement will be assess through recent academic achievement or performance in exams
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Fatima Jinnah Women University Ethics Review Board
Rawalpindi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active physical education lessons and physical education plan and Recess or lunch time activities in people with School Based Intervention, run by Fatima Jinnah Women University at 1 site in Pakistan.
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 3 inclusion and 2 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 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation towards Physical Activity (time frame: 1 month). The study lists 5 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 3 Dec 2020.