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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06196645
Other study ID # EskisehirTU-SBF-GY02
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 10, 2024
Est. completion date July 15, 2024

Study information

Verified date December 2023
Source Eskisehir Technical University
Contact Günay Yildizer, Ph.D.
Phone +905373385817
Email gunayyildizer@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effects of a physical activity intervention plan developed based on the theory of planned behavior on the physical activity levels of adolescent girls, their sedentary time and their knowledge about physical activity. Within the scope of this research, answers to the following research questions will be sought; 1. Is there a difference in physical activity level between participants in the physical activity intervention plan groups and the control group? 2. Is there a difference in terms of daily sedentary time between participants in the physical activity intervention plan groups and the control group? 3. Is there a difference in beliefs about physical activity between participants in the physical activity intervention plan groups and the control group? In this context, researchers will compare 3 groups within the scope of the data provided by two preliminary studies conducted previously. These groups; (1) intervention group based on the theory of planned behavior, (2) intervention group based on the theory of planned behavior with family participation, (3) control group.


Description:

While the physical activity participation of adolescents in Turkey and around the world is quite low, this is more pronounced for girls. The low physical activity participation rates seen in this group shed light on the negative situations to be seen in the future in terms of public health and the economy. The fact that health-related behavior patterns acquired during adolescence form a highly effective basis for the rest of life makes it necessary to develop effective, low-cost physical activity intervention plans for adolescents that take into account individual needs. Research on physical activity intervention, while generally targeting groups with low physical activity levels, is applied in different contexts (school, family, school and family, living environment) where these groups spend their time. In this respect, school-based interventions, where adolescents spend most of their time, come to the fore. For plans to be effective, they should be based on a research process and their theoretical foundations should be inclusive. While the theory of planned behavior, which has an important place in shaping health behaviors and explains the formation and continuity of behavior by addressing the attitude, norms created by the social environment, and the control perceived by the person towards the behavior, constitutes the theoretical basis of this research, the aim of the research is to create and test a school-based physical activity intervention plan based on the theory of planned behavior, targeting adolescent girls. Qualitative and quantitative research methods were applied through a multi-stage design process, and the findings revealed the need to create an effective intervention plan guide for adolescent girls in Turkish society. These phases included (I) a study to explain which factors are important for physical activity behavior in adolescent girls, including open-ended questions and semi-structured interviews; (II) the process of developing a measurement tool in the light of the data obtained with these qualitative methods; and (III) survey research that adopted the general survey model and reached a large population. As a result of this process, which has been going on for about 48 months, the physical activity intervention plan to be implemented has been shaped. With this intervention, it is aimed to create significant effects among adolescent girls in terms of physical activity and sedentary time and to positively affect their beliefs about physical activity. The physical activity intervention plan to be developed according to the planned behavior theory will be based on the information obtained in pilot studies that have already been completed. The plan will be implemented in selected high schools affiliated with the Turkish Ministry of National Education. The developed protocol is planned to be implemented over two different time periods. The reason for this is that seasonal factors are emphasized as an important factor in carrying the gains provided in physical activity intervention plans into daily life (Rowland et al., 2006; Tucker & Gililand, 2007; Belanger et al., 2009; Kornides et al., 2018). The contents of the intervention plan will be delivered to students for 2 hours in selected physical education and sports classes. It is planned to implement this plan in physical education classes for one semester. Considering that the implementation will take place in one academic year, data will be collected at the beginning and end of the first semester and at the end of the second semester. Data collection processes are planned to take approximately 1-1.5 months. Thus, it will be ensured that this application will be carried out for 3-3.5 months in a semester. While planning this period, Owen et al. (2017) reviews and meta-analyses were taken into consideration. Structurally, the physical activity intervention plan is planned to include four dimensions based on the theory of planned behavior. The first two of these are: (I) transferring information on health-related physical fitness and physical activity; (II) taking individual responsibility for physical activity follow-up; and (II) simple individual planning, which will affect the level of physical activity at the individual level. Another dimension is the inclusion in the program of the types of activities that the female adolescents (III) chose and declared that they would enjoy participating in. The last dimension, as emphasized in the theory of planned behavior, is the invitation of significant others, which are the family, teachers, and other students, including male students, with whom the target group is in constant social interaction, to this plan, and all of the practices are open to them. However, data will not collected from them.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date July 15, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 18 Years
Eligibility Inclusion Criteria: - Bein high school student - Do not have any health problems that would prevent from participating in exercise, - Not participating any another exercise/training program during the research process, - Voluntarily participation -Being suitable for exercise participation according to Physical Activity -- Readiness Questionnaire (PARQ) test results Exclusion Criteria: - Presence of any significant health conditions that may pose a risk during exercise (e.g., heart conditions, severe respiratory disorders, uncontrolled hypertension). - A history of musculoskeletal injuries or conditions that would limit participation in physical fitness activities. - Current or recent participation in another exercise or fitness program. - Inability to provide informed consent or unwillingness to participate voluntarily. - Inability to provide parental consent. - Any medical condition that contraindicates exercise or physical activity as determined by a healthcare professional. - Age restrictions (younger than 15 and older than 18). - Cognitive impairments that would hinder the ability to understand and follow exercise instructions.

Study Design


Intervention

Behavioral:
Physical Activity Intervention Based on Theory of Planned Behavior
The content of the intervention plan to be implemented consists of the following components: (I) transferring knowledge about health-related physical fitness and physical activity, (II) taking individual responsibility for physical activity monitoring and simple individual planning, (III) including in the program the types of activities that female adolescents choose and declare that they would enjoy participating in.
Physical Activity Intervention Based on Theory of Planned Behavior with Parental Participation
The content of the intervention plan to be implemented consists of the following components: (I) transferring knowledge about health-related physical fitness and physical activity, (II) taking individual responsibility for physical activity monitoring and simple individual planning, (III) including in the program the types of activities that female adolescents choose and declare that they would enjoy participating in. In this group, at least one parent will also be involved.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Eskisehir Technical University The Scientific and Technological Research Council of Turkey

References & Publications (5)

Belanger M, Gray-Donald K, O'Loughlin J, Paradis G, Hanley J. Influence of weather conditions and season on physical activity in adolescents. Ann Epidemiol. 2009 Mar;19(3):180-6. doi: 10.1016/j.annepidem.2008.12.008. — View Citation

Kornides ML, Rimm EB, Chavarro JE, Gillman MW, Rosner B, Field AE. Seasonal Variations in Meeting Physical Activity Recommendations and Development of Overweight during Adolescence. Child Obes. 2018 Jan;14(1):33-40. doi: 10.1089/chi.2017.0118. Epub 2017 Sep 5. — View Citation

Owen MB, Curry WB, Kerner C, Newson L, Fairclough SJ. The effectiveness of school-based physical activity interventions for adolescent girls: A systematic review and meta-analysis. Prev Med. 2017 Dec;105:237-249. doi: 10.1016/j.ypmed.2017.09.018. Epub 2017 Sep 28. — View Citation

Rowlands AV, Hughes DR. Variability of physical activity patterns by type of day and season in 8-10-year-old boys. Res Q Exerc Sport. 2006 Sep;77(3):391-5. doi: 10.1080/02701367.2006.10599373. No abstract available. — View Citation

Tucker P, Gilliland J. The effect of season and weather on physical activity: a systematic review. Public Health. 2007 Dec;121(12):909-22. doi: 10.1016/j.puhe.2007.04.009. Epub 2007 Oct 24. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Affection for Physical Activity Affection for Physical Activity is one of the subdomains of the Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of ten items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 50, and the minimum score is 5. The higher scores obtrained in the subdimension represent higher belief in that subscale. 4 months
Primary Social Expectations in Physical Activity Social Expectations in Physical Activity is one of the subdomains of the Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of three items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 15, and the minimum score is 3. The higher scores obtained in the subdimension represent higher belief in that subscale. 4 months
Primary Health Expectations in Physical Activity Health Expectations in Physical Activity is one of the subdomains of the Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of eight items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 40, and the minimum score is 8. The higher scores obtained in the subdimension represent higher belief in that subscale. 4 months
Primary Attitutde towards Physical Activity Attitude towards Physical Activity is a composite score of Affection for Physical Activity, Social Expectations in Physical Activity and Health Expectations in Physical Activity subdimensions of the Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of twenty-one items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 105, and the minimum score is 21. The higher scores obtained in the subdimension represent higher attitudes. 4 months
Primary Parental Support in Physical Activity Parental Support in Physical Activity is one of the subdomains of the Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of three items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 15, and the minimum score is 3. The higher scores obtained in the subdimension represent higher belief in that subscale. 4 months
Primary Peer Support in Physical Activity Peer Support in Physical Activity is one of the subdomains of Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of three items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 15, and the minimum score is 3. The higher scores obtained in the subdimension represent higher belief in that subscale. 4 months
Primary Subjective Norms in Physical Activity Subjective Norms in Physical Activity is a composite score of Parental Support in Physical Activity and Peer Support in Physical Activity, a subdimension of Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of six items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 30, and the minimum score is 6. The higher scores obtained in the subdimension represent higher attitudes. 4 months
Primary Perceived Behavioral Control in Physical Activity Perceived Behavioral Control in Physical Activity is one of the subdomains of the Physical Activity Belief Questionnaire (PAB-Q). The subscale consisted of five items answered on a 5-point Likert scale. The maximum score that can be obtained from this subscale is 25, and the minimum score is 5. The higher scores obtained in the subdimension represent higher belief in that subscale. 4 months
Primary Body Mass Index (BMI) Body Mass Index (BMI) is a numerical value derived from an individual's weight and height. The BMI is going to be expressed in units of kg/m² (kilograms per square meter) in the metric system. 4 months
Primary Average kcals per day This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Average kilocalories (kcals) per day refer to the mean energy expenditure related to physical activity over a 24-hour period, as estimated by the wGT3X-BT accelerometer. 4 months
Primary Time in light physical activity This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Time in light physical activity is the duration spent in activities classified as light intensity by the wGT3X-BT accelerometer. 4 months
Primary Tme in moderate to vigorous physical activity This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Time in moderate to vigorous physical activity is the combined duration spent in activities classified as both moderate and vigorous intensity by the wGT3X-BT accelerometer. 4 months
Primary Time in vigorous physical activity This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Time in vigorous physical activity represents the duration spent in activities classified as vigorous intensity by the wGT3X-BT accelerometer. 4 months
Primary Time in moderate physical activity This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Time in moderate physical activity is the duration spent in activities classified as moderate intensity by the wGT3X-BT accelerometer. 4 months
Secondary Body Weight Body weight refers to the mass of an individual's body, and is going to measured by using Tanita BC-601 in kg. 4 months
Secondary Body Height Body weight is a measurement of the vertical distance from the bottom of the feet to the top of the head when a person is standing upright. It is going to be measured by using Leicester Height Measure MK-II in m. 4 months
Secondary Activity Kilocalories This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Activity kilocalories (activity kcals), as an outcome measure from a GT3X Link accelerometer, refer to the estimated energy expenditure related to physical activity over a specified time period. The accelerometer, which records acceleration in three dimensions, allows for the assessment of different activity intensities, helping to quantify the amount of energy expended during various activities 4 months
Secondary Total Sedentary Bout This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Total sedentary bouts, as an outcome measure from a GT3X Link accelerometer, typically refer to the cumulative duration or count of extended periods of sedentary behavior detected by the accelerometer over a specified time period. Sedentary bouts are intervals during which a person is engaged in minimal or no physical activity, often characterized by activities such as sitting or lying down. 4 months
Secondary Average kcals per hour This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Average kilocalories (kcals) per hour represent the mean energy expenditure related to physical activity calculated on an hourly basis using data recorded by the wGT3X-BT accelerometer. 4 months
Secondary Total sedentary bouts This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Total sedentary bouts refer to the cumulative count or duration of extended periods of sedentary behavior detected by the wGT3X-BT accelerometer over a specified time period. 4 months
Secondary Total sedentary breaks This outcome measure is going to be measured by Actigraph wGT3X-BT accelerometer. Total sedentary breaks represent the cumulative count of interruptions in sedentary behavior detected by the wGT3X-BT accelerometer over a specified time period. 4 months
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