NCT06408844

Brief Summary

The health-related benefits of physical activity are well established for all age groups. It also has positive effects on memory, executive function and school performance in children and adolescents. However, it is known that 81% of individuals between the ages of 11-17 live a life that is not physically active enough. The World Health Organization recommends interventions to increase physical activity. In this study, 48 students from 5th, 6th and 7th grades will be selected from randomly selected secondary schools in Karaman central district and will be divided into experimental and control groups. In this randomized controlled study, behavior change intervention with the 5A model will be applied to the experimental group, and no intervention will be applied to the control group. Physical activity levels, physical and psychosocial health of children in both groups will be evaluated at the beginning of the intervention, at Week 8 and at Week 28. Physical activity diary, "Physical activity scale for 4-8 Grades" scale will be used to measure children's physical activity levels. For their physical health, body composition, strength, flexibility and functional capacity will be evaluated. Quality of life with the "Pediatric Quality of Life 4.0 Inventory" for psychosocial health; Cognitive functions will be evaluated with "CNS Vital Signs Cognitive Performance and Attention Tests". This study aims to evaluate the sustainability effect of the 5A intervention on physical activity and its impact on physical health and psychosocial health.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

October 7, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

May 7, 2024

Last Update Submit

May 9, 2024

Conditions

Keywords

5A Modelchildbehaviour changephysical activityhealth promotion

Outcome Measures

Primary Outcomes (3)

  • Physical activity level

    Children's physical activity level will be determined using the Paq-c survey.

    1 day

  • Physical health

    Children's body composition, aerobic capacity, anaerobic capacity, strength and flexibility will be evaluated.

    1 day

  • Psychosocial Health

    Children's psychosocial health will be assessed with the CNSVS procedure.

    1 day

Secondary Outcomes (3)

  • Physical Activity attitude

    1 day

  • Behavior Change Step

    1 day

  • Children's Quality of Life

    1 day

Study Arms (2)

Experimental group

EXPERIMENTAL

Training to improve physical activity behavior will be given to the experimental group for 8 weeks, based on the 5A model.

Behavioral: Physical activity behavior change program implemented with 5A model

Control group

NO INTERVENTION

The control group will not receive any intervention and will be asked to continue their routine lives.

Interventions

According to the 5A model, the personal action plan includes the following items: 1. List specific goals by behavioral period 2. List obstacles and strategies to address them 3. Determine follow-up plan 4. Sharing the plan with the child and family In accordance with this plan, it is aimed to increase physical activity behavior in the classroom and during online meetings for 8 weeks. Additionally, after the training, motivational reminders will be held at regular intervals until the 28th week.

Experimental group

Eligibility Criteria

Age10 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being a middle school student
  • Being between the ages of 10-12
  • Getting \<3.16 points from the "Physical activity scale for grades 4-8"

You may not qualify if:

  • Having a condition where exercise is contraindicated
  • Families or children do not give consent to participate in the study.
  • Having a psychosocial problem that prevents adaptation to work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alparslan Ortaokulu

Karaman, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sedentary BehaviorHealth BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Filiz Özdemir, Ass. Prof.

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: There are two groups in this study: the experimental group and the control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

October 7, 2023

Primary Completion

June 30, 2024

Study Completion

December 30, 2025

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations