Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency

Physical Inactivity Clinical Trial

Official title:

Developing a Physical Activity Program Based on Behavior Change Models in Children and Investigation of Its Efficiency. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05681832
• Other study ID #: E-74555795-050.01.04-567380
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: Mira Amer, PT
• Phone: 00905343069295
• Email: mira.amr13[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The COVID-19 pandemic, which started in 2019, has negatively affected the lives of all humanity in many ways, especially with the decrease in physical activity. Due to quarantines, schools continued their educational activities online for a long time. While physical inactivity in children was a serious problem even in the pre-pandemic period, the restrictions imposed due to pandemic conditions had a catastrophic effect on the physical inactivity levels of children. It has been reported that children reach the recommended physical activity levels while they are at school. Studies show that the habits we have acquired since childhood are most likely habits that we can have for a lifetime. The effectiveness of behavior change theories and models has been proven in studies conducted to gain exercise habits in various age groups. In the literature, many theories such as Self-Determination Theory (SDT), Transtheoretical Model, Planned Behavior Theory, and Social Cognitive Theory have been used to help children gain exercise habits. In a cross-sectional study involving 462 children aged 7-11, the effectiveness of the SDT model on children's physical activity motivation was examined. The results showed that there is a positive relationship between children's motivation based on activity enjoyment and satisfaction and physical activity scores. It has been reported that applications based on theory are promising for future interventions aimed at increasing physical activity levels in children. However, there is a limited number of studies in the literature to gain exercise habits in children, and there is no evidence that which model will provide better results. In a postgraduate thesis done in Turkey in 2021, online exercise training based on behavior change theories and strategies was applied to gain exercise habits in children. They reported limited evidence that they obtained Although very few children participated in the study due to restrictions during the COVID-19 pandemic, they reported limited evidence that children achieved positive changes in health behavior. For these reasons, the planning 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 in children attending primary school.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Behavior, Child
• Physical Inactivity

Intervention

Behavioral:
• Intervention group
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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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