NCT06196645

Brief 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. 1.Is there a difference in physical activity level between participants in the physical activity intervention plan groups and the control group?
  2. 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. 3.Is there a difference in beliefs about physical activity between participants in the physical activity intervention plan groups and the control group?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

December 26, 2023

Last Update Submit

May 14, 2025

Conditions

Keywords

Theory of planned behaviorphysical activity interventionadolescent girls

Outcome Measures

Primary Outcomes (14)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (7)

  • Body Weight

    4 months

  • Body Height

    4 months

  • Activity Kilocalories

    4 months

  • Total Sedentary Bout

    4 months

  • Average kcals per hour

    4 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group-1

EXPERIMENTAL

Participants in this arm of the experimental group will participate in a school-based intervention program that is based on the theory of planned behavior and includes behavior change techniques. These participants will participate in the intervention plan only in physical education and sports classes at their schools.

Behavioral: Physical Activity Intervention Based on Theory of Planned Behavior

Control Group

NO INTERVENTION

This group will not be involved in any implementation until the end of the research. Ethically, after the research is completed, the proposal to repeat the most effective intervention arm for this group will be presented to the participants in this group.

Interventions

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.

Intervention Group-1

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir Technical University

Eskişehir, Tepebaşı, 26555, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 28964852BACKGROUND
  • 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.

    PMID: 19217000BACKGROUND
  • 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.

    PMID: 28872346BACKGROUND
  • 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.

    PMID: 17920646BACKGROUND
  • 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.

    PMID: 17020083BACKGROUND

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Günay Yıldızer, Ph.D.

    Eskiehir Technical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

February 10, 2024

Primary Completion

June 15, 2024

Study Completion

December 31, 2024

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations