NCT07265219

Brief Summary

Excessive engagement with digital devices among adolescents has become a significant public health concern, contributing to reduced physical activity and associated health risks. This study assessed the impact of the PROBTEC Management Program-an intervention structured around the Health Promotion Model-on technology-related behaviors and activity levels in adolescents. A randomized controlled trial was implemented in 10 public middle schools in Türkiye with a total sample of 200 students aged 14-15 years. Schools were allocated to either the intervention or control condition using cluster randomization. The intervention spanned six weeks and combined health education sessions, guided physical activity practices, and parent-focused components. Measures were obtained at four time points (baseline, 1 week, 3 months, 6 months) using validated questionnaires, pedometer-based step counts, and the International Physical Activity Questionnaire. Data were analyzed using repeated measures statistical techniques and standardized effect size calculations. Participants receiving the PROBTEC intervention demonstrated notable improvements over time. Compared with controls, the intervention group exhibited reduced indicators of problematic technology engagement and perceived exercise barriers, alongside increases in perceived exercise benefits, physical activity self-efficacy, and total MET scores. Findings indicate that the PROBTEC Management Program supports positive behavioral changes by reducing unhealthy technology use and encouraging more active lifestyles among adolescents. The sustained effects observed across the 6-month follow-up period suggest that this school-based, theory-driven model may be a practical and scalable strategy for adolescent health promotion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

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

March 27, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

November 22, 2025

Last Update Submit

December 2, 2025

Conditions

Keywords

Health Promotion Modelproblematic technology usephysical activityrandomized controlled trialadolescents

Outcome Measures

Primary Outcomes (1)

  • Problematic Technology Use Score

    Problematic technology use will be assessed using the Technology Addiction Scale, a validated 32-item scale developed for adolescents. The scale uses a 5-point Likert response format and has four subscales: Social Media Addiction, Instant Messaging Addiction, Online Gaming Addiction, and Website Addiction. Total scores range from 0 to 120, with higher scores indicating more severe technology addiction. Score interpretation: 0-24: No addiction 25-48: Low addiction 49-72: Moderate addiction 73-96: High addiction 97-120: Full addiction The scale demonstrated good internal reliability (Cronbach's α = .86 in the original study; α = .97 in the present study).

    Day 0, Day 7, Day 90, Day 180.

Study Arms (2)

Experimental: PROBTEC Intervention Group

EXPERIMENTAL

Adolescents in the experimental arm received the PROBTEC Management Program, a structured six-week behavioral intervention based on the Health Promotion Model.

Behavioral: PROBTEC Management Program

Control: Standard School Routine (No Intervention)

NO INTERVENTION

Participants in the control arm continued their usual school schedule without receiving any structured health education or physical activity program related to technology use. They did not participate in any component of the PROBTEC intervention. After the study was completed, informational brochures were provided to ensure ethical equivalence.

Interventions

Intervention Description (Distinctive Features) - PROBTEC Program The PROBTEC Management Program is a multi-component behavioral intervention specifically designed to address problematic technology use among adolescents within a school setting. Unlike standard health education approaches, this program integrates all core constructs of the Health Promotion Model (HPM) and combines them with structured physical activity strategies and a family-engagement framework. Its distinguishing features include: Theory-Driven Structure: The entire intervention is explicitly grounded in the Health Promotion Model. Each session targets specific HPM constructs such as perceived benefits, perceived barriers, self-efficacy, situational influences, and interpersonal support. This provides a comprehensive theoretical basis that differentiates the program from generic technology reduction or physical activity programs. Combined Digital Behavior + Physical Activity Approach: Most existing adolescent inte

Experimental: PROBTEC Intervention Group

Eligibility Criteria

Age14 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents aged 14-15 years
  • Volunteering to participate in the study
  • Reporting more than two hours of daily screen time
  • Able to complete assessments at all required time points

You may not qualify if:

  • Diagnosed mental disabilities
  • Diagnosed physical disabilities
  • Presence of chronic illnesses
  • Any condition that prevents participation in the intervention or assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University, Faculty of Health Sciences

Karabük, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Nesrin Arslan,, PhD

    Karabuk University

    PRINCIPAL INVESTIGATOR
  • aysun Ardic

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to their group assignment. Although the intervention and control conditions differed in content, students were not informed whether their school had been allocated to the experimental arm or the control arm. The program was delivered within the normal school schedule, and activities were presented in a way that did not disclose group status to the adolescents. Researchers responsible for implementing the intervention were aware of the allocation due to the need to conduct the program; however, participants remained unaware of their assignment throughout the study. Outcome assessments were conducted using standardized scales and objective physical activity monitoring to support unbiased data collection.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Assistant Professor

Study Record Dates

First Submitted

November 22, 2025

First Posted

December 4, 2025

Study Start

March 27, 2023

Primary Completion

May 12, 2023

Study Completion

November 29, 2023

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the study involves minors and includes sensitive behavioral data that cannot be released under institutional and national data protection regulations. Only aggregated results will be made publicly available.

Locations