NCT07607847

Brief Summary

Adolescence is a critical developmental period in which lifelong health behaviors are shaped, and behaviors acquired during this stage significantly influence health outcomes in adulthood. Physical activity, healthy nutrition, adequate sleep, stress management, and positive social relationships are among the key determinants of adolescent health. However, current evidence indicates that physical inactivity, unhealthy dietary habits, sedentary lifestyles, and psychosocial problems remain highly prevalent among adolescents globally. In addition, insufficient access to health information and inadequate health information-seeking behaviors among adolescents have been reported to be associated with risky health behaviors. Therefore, the development of healthy lifestyle behaviors in adolescents is considered a public health priority. Schools are recognized as strategic settings for health-promoting interventions targeting adolescents due to their significant social and educational influence on health behaviors. Recent systematic reviews and meta-analyses report that school-based and multi-component interventions have positive effects on adolescents' health behaviors and psychosocial well-being. The integration of behavioral and psychosocial components in school-based health education programs has been associated with more effective and sustainable improvements in adolescent health outcomes . In this process, school health nurses play a critical role in planning and implementing preventive and health-promoting interventions for adolescents . Moreover, it has been reported that healthy behaviors gained through school health nursing interventions may persist into adulthood . Additionally, a systematic review of health education interventions has shown that multi-component approaches-such as classroom education combined with school policies, parental involvement, and school-community collaboration-produce more significant effects on adolescent health outcomes. In recent years, there has been increasing interest in complementary approaches supporting stress management and emotional well-being in school-based interventions. In this context, laughter yoga is described as a low-cost, feasible, and group-based method associated with reduced stress, improved psychological well-being, and enhanced social interaction. Experimental studies conducted with adolescents have also demonstrated that laughter yoga has positive effects on school burnout, hope, and educational stress. However, the literature indicates a limited number of studies examining the integration of laughter yoga into structured school-based health education programs and its effects on healthy lifestyle behaviors. In line with the life-course health perspective, school-based interventions aimed at health promotion during childhood and adolescence are reported to be critical for the sustainability of healthy lifestyle behaviors. In this context, the PRECEDE-PROCEED Model is a theoretical framework widely used in the planning and implementation of health promotion programs, systematically assessing behavioral, environmental, and psychosocial factors influencing health behaviors. Studies based on the PRECEDE-PROCEED Model have demonstrated its effectiveness in improving health behaviors among adolescents. Furthermore, current evidence emphasizes that parental involvement in school-based health interventions strengthens the sustainability of behavior change, highlighting the need for further research in this area. The literature indicates that no studies have examined the effects of a health education program based on the PRECEDE-PROCEED Model integrated with laughter yoga on adolescents' healthy lifestyle behaviors. This gap highlights an important research need for interventions that combine a theoretical behavior change framework with complementary practices that may enhance psychosocial well-being. Study aim Accordingly, the aim of this study is to evaluate the effect of a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga on healthy lifestyle behaviors of secondary school students. Study hypotheses H1: Students who receive a health education program based on the PRECEDE-PROCEED Model and integrated with laughter yoga will have significantly higher healthy lifestyle behavior scores compared to the control group.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

April 17, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 19, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 26, 2026

Completed
Last Updated

May 26, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

May 19, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

AdolescentsSchool HealthHealth PromotionHealthy Lifestyle BehaviorsLaughter YogaPRECEDE-PROCEED Model

Outcome Measures

Primary Outcomes (2)

  • Adolescent Lifestyle Profile Scale

    The Adolescent Lifestyle Profile Scale (ALP) is the adolescent-adapted version of the Health-Promoting Lifestyle Profile II, which was developed based on Pender's Health Promotion Model (Pender et al., 2015). The scale was developed by Catherine Hendricks and colleagues to assess health-promoting lifestyle behaviors among individuals in early, middle, and late adolescence (Hendricks et al., 2006). The Turkish validity and reliability study of the scale was conducted by Ardıç and Esin (2015) (Ardic \& Esin, 2015). The four-point Likert-type scale is scored between 1 ("Never") and 4 ("Always"), with total scores ranging from 40 to 160. Higher scores indicate higher levels of health-promoting lifestyle behaviors. The scale consists of 40 items and seven subdimensions: health responsibility, physical activity, nutrition, positive life perspective, interpersonal relations, stress management, and spiritual health (Ardic \& Esin, 2015). The scale does not h

    1 week before intervention and 1 week post-intervention

  • Participant Information Form

    This form was developed based on the literature and consists of 11 questions related to sociodemographic characteristics and 10 questions regarding school and healthy lifestyle behaviors.

    Baseline (1 week before intervention)

Secondary Outcomes (1)

  • Education Program Evaluation Form

    1 week post-intervention

Study Arms (2)

Intervention Group:Laughter yoga-integrated health education

EXPERIMENTAL

Students in the intervention group received a 30-35-minute health education session once a week, and informative brochures were distributed to their families during the intervention process. Following each education session, 15-20-minute laughter yoga practices were conducted.

Behavioral: Laughter yoga-integrated health education

Control Group

NO INTERVENTION

Participants will undergo a pre-test with no additional intervention; post-tests will be conducted at the end of the study, and laughter yoga will be offered to volunteers.

Interventions

A 30-35-minute health education session was provided once a week for six weeks, and informative brochures were distributed to families. Following the education sessions, 15-20-minute laughter yoga practices were conducted.

Intervention Group:Laughter yoga-integrated health education

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Voluntary participation of the student and parent/guardian
  • Being enrolled as an 8th-grade student
  • No hearing, visual, or cognitive impairment affecting participation in data collection

You may not qualify if:

  • Presence of any medical condition contraindicating physical activity
  • History of abdominal surgery within the past 3 months
  • Diagnosis of diabetes, glaucoma, hypertension, epilepsy, hernia, or asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursing Fakulty,

Ankara, Altındağ, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Health BehaviorAdolescent BehaviorHealth Education

Condition Hierarchy (Ancestors)

BehaviorAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and Compliance

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: The study was planned as a randomized controlled experimental design with a pretest-posttest.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD

Study Record Dates

First Submitted

May 19, 2026

First Posted

May 26, 2026

Study Start

April 17, 2026

Primary Completion

May 18, 2026

Study Completion

May 18, 2026

Last Updated

May 26, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations