Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-30 @ 3:37 PM
Study NCT ID:
NCT04487132
Status:
UNKNOWN
Last Update Posted:
2020-12-03
First Post:
2020-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-02', 'studyFirstSubmitDate': '2020-07-10', 'studyFirstSubmitQcDate': '2020-07-22', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivation towards Physical Activity', 'timeFrame': '1 month', 'description': '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 .'}, {'measure': 'Level of Physical Activity', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Psychosocial Outcomes', 'timeFrame': '1 month', 'description': '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).'}, {'measure': 'Self Concept', 'timeFrame': '1 month', 'description': '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.'}, {'measure': 'Academic Achievement', 'timeFrame': '1 month', 'description': 'Academic Achievement will be assess through recent academic achievement or performance in exams'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['School Based Intervention']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants from grade 6th to 8th with in age range of 10-15 years.\n* Participants who have lack of physical activity.\n* Participants who provide consent to take part in the intervention.\n\nExclusion Criteria:\n\n* Those participants who do not provide consent to take part in intervention will not be eligible take part in intervention.\n* Participants who are having any physical disability or medical condition that compromises their mobility will not take part in intervention.'}, 'identificationModule': {'nctId': 'NCT04487132', 'briefTitle': 'Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Fatima Jinnah Women University'}, 'officialTitle': 'Impact of School Based Intervention on Motivation Towards Physical Activity and Psychosocial Outcomes Among Adolescents: A Randomized Control Trial', 'orgStudyIdInfo': {'id': 'FJWU/Reg/2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active physical education lessons and physical education plan', 'description': 'Active physical education lessons and physical education plan provided to the controlled group', 'interventionNames': ['Behavioral: Active physical education lessons and physical education plan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Recess or lunch time activities', 'description': 'Preparing the playground by offering adequate spaces and games provided to the experimental group', 'interventionNames': ['Behavioral: Active physical education lessons and physical education plan', 'Behavioral: Recess or lunch time activities']}], 'interventions': [{'name': 'Active physical education lessons and physical education plan', 'type': 'BEHAVIORAL', 'otherNames': ['physical education plan'], 'description': '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.', 'armGroupLabels': ['Active physical education lessons and physical education plan', 'Recess or lunch time activities']}, {'name': 'Recess or lunch time activities', 'type': 'BEHAVIORAL', 'otherNames': ['physical activities group intervention'], 'description': '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 )', 'armGroupLabels': ['Recess or lunch time activities']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rawalpindi', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Sajida Naz, Dr', 'role': 'CONTACT', 'email': 'dr.sajida@fjwu.edu.pk', 'phone': '0332-9370378'}], 'facility': 'Fatima Jinnah Women University Ethics Review Board', 'geoPoint': {'lat': 33.59733, 'lon': 73.0479}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fatima Jinnah Women University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principle investigator', 'investigatorFullName': 'Anmol Ayaz', 'investigatorAffiliation': 'Fatima Jinnah Women University'}}}}