NCT04487132

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 10, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

December 3, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

July 10, 2020

Last Update Submit

December 2, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 .

    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.

    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).

    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.

    1 month

  • Academic Achievement

    Academic Achievement will be assess through recent academic achievement or performance in exams

    1 month

Study Arms (2)

Active physical education lessons and physical education plan

ACTIVE COMPARATOR

Active physical education lessons and physical education plan provided to the controlled group

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

Behavioral: Active physical education lessons and physical education planBehavioral: Recess or lunch time activities

Interventions

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.

Also known as: physical education plan
Active physical education lessons and physical education planRecess or lunch time activities

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 )

Also known as: physical activities group intervention
Recess or lunch time activities

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima Jinnah Women University Ethics Review Board

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 27, 2020

Study Start

July 10, 2020

Primary Completion

December 10, 2020

Study Completion

December 30, 2020

Last Updated

December 3, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations