NCT05681832

Brief Summary

The aim of our study is to develop a physical activity program based on behavioral change models for children and to investigate the effectiveness of the physical activity program we have developed for children attending primary school. There is a limited number of studies in the literature on exercise habits in children, and there is no evidence on which model will provide better results when integrated into school or training programs. Although behavioral modification-based physical activity programs for children have been established and their effectiveness has been investigated in many different countries, there are limited randomized controlled studies on this subject. Currently, there are no randomized control studies on the topic in Turkey. Our study will be the first study in which a school-based physical activity program based on behavioral change models in Turkish children is developed and its effectiveness is investigated. We believe that our study will contribute to the development of new models and protocols to improve the health of children in Turkey and the world and to provide behavior change methods that are research-based to combat physical inactivity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

December 28, 2022

Last Update Submit

May 11, 2024

Conditions

Keywords

childbehavior change modelsHIITExercisephysical activityphysical inactivitymotivation

Outcome Measures

Primary Outcomes (5)

  • The Cognitive Behavioral Physical Activity Questionnaire

    This questionnaire will test the changes in behavior towards physical activity in children. The scale consists of 3 sub-dimensions, namely self-regulation and personal barriers, and a total of 15 statements. All statements in the scale are scored with a 5-point Likert Type rating as "1. I totally disagree,…, 5. I totally agree".

    Change from baseline to 8 weeks

  • The physical Activity Stages Of Change Questionnaire

    This questionnaire will specifiy which stage of change the child is in according to the transtheoretical model. Transtheoretical Model, explains whether the individual is ready to change their behavior and describes the behavior change process that occurs in stages. This will help us know how to modify the program to work out well for each child.

    Change from baseline to 8 weeks

  • Motivation Scale For Participation In Physical Activity

    This scale will evaluate the level of motivation to participate in physical activity.

    Change from baseline to 8 weeks

  • The physical activity efficacy scale

    This scale consists of 5 dimensions and 26 items (at school: 6 items, transportation: 3 items, indoor: 5 items, leisure and recreation: 6 items, in-school travel and transportation: 6 items). The scale consists of two parts. In the first part, demographic information is asked, and in the second part, how much they trust themselves to take part in physical activities in the five physical activity areas. A 10-point Likert-type range was used to score the items (0= "I am not confident at all" and 100= "I am totally confident"). The overall average score is between 0 and 100. High scores will indicate a high level of physical activity efficacy.

    Change from baseline to 8 weeks

  • The Physical Activity Questionnaire

    It will assess physical activity levels in children. It is is a self-administered, 7-day activity recall tool.

    Change from baseline to 8 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL
Behavioral: Intervention group

Control group

NO INTERVENTION

Interventions

The children in this group will participate in a 15-minute HIIT (High-intensity interval training) program twice a week for eight weeks. Motivational interviewing through presentations and Kahoot for the children and their parents will be done at the program's beginning, middle, and end. The HIIT program will consist of 2.5 minutes of warm-up 12.5 exercises then a cool-down period of 5 minutes. The intensity of the exercise was increased based on each kid's performance and monitored during the sessions using a smartwatch.

Intervention group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Voluntarily wanting to join the program
  • Not having any chronic diseases
  • Be able to read and write
  • To have the cognitive skills to understand and answer the questionnaire
  • To be a student at primary or secondary school.

You may not qualify if:

  • Having a vision or hearing problem
  • Have a diagnosis of chronic cardiac, neurological, or rheumatic disease
  • Doing regular exercise/sports for the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Child BehaviorSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSc.P.T.

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 12, 2023

Study Start

November 1, 2022

Primary Completion

March 1, 2023

Study Completion

April 1, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations