Health BehaviorLifestyleNCT07607847
Laughter Yoga Integrated PRECEDE-PROCEED Health Education Program in Adolescents
A study testing Laughter yoga-integrated health education in people with Health Behavior and Health Lifestyle Behaviors, run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior, Health Lifestyle Behaviors, Adolescent
- What is being tested?
- Laughter yoga-integrated health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Apr 2026to 18 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a PRECEDE-PROCEED Model-Based Health Education Program Integrated With Laughter Yoga on Adolescents' Healthy Lifestyle Behaviors
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.
Read more
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.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the effects of a PRECEDE-PROCEED Model-based laughter yoga-supported education program on adolescent health-related behaviors among 8th-grade students in a public middle school in Ankara, Türkiye.
The study was conducted in a socioeconomically disadvantaged district to ensure contextual relevance. A single middle school was selected using simple random sampling, and all eligible 8th-grade students were invited to participate. Participants who met the inclusion criteria and provided parental consent were randomly assigned to intervention and control groups in a 1:1 ratio using computer-generated randomization performed by an independent researcher. Allocation concealment was maintained until assignment. Due to the nature of the intervention, blinding of participants and intervention providers was not possible; however, outcome assessors and data analysts were blinded to group allocation.
The intervention group received a structured 6-week program based on the PRECEDE-PROCEED Model, consisting of weekly health education sessions combined with laughter yoga practices. Health education sessions included interactive materials and visual resources, while laughter yoga sessions were delivered by a certified researcher and included breathing techniques, group exercises, and relaxation activities. Educational materials were also shared with families to support reinforcement outside the school environment. The control group continued with the standard school curriculum and did not receive any intervention during the study period.
Data were collected at three time points: baseline, immediately after the 6-week intervention, and at 3-month follow-up. The intervention's short-term and medium-term effects were evaluated through standardized measurement tools assessing behavioral and psychosocial outcomes. After completion of data collection, a single-session educational activity was offered to the control group for ethical reasons.
Statistical analyses were performed using appropriate parametric and non-parametric tests based on data distribution. Group differences and changes over time were analyzed using repeated-measures approaches, and effect sizes were calculated to determine the magnitude of intervention effects. Statistical significance was set at p < 0.05.
- Conditions
- Health Behavior, Health Lifestyle Behaviors, Adolescent, Adolescent Behavior, Laughter Therapy, Precede Proceed Model
- Being tested
- Laughter yoga-integrated health education
- Keywords
- Adolescents, School Health, Health Promotion, Healthy Lifestyle Behaviors, Laughter Yoga, PRECEDE-PROCEED Model
- Medical subject headings
- Health Behavior, Adolescent Behavior, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yoga-integrated health educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline (1 week before intervention)
Secondary outcomes (1)
Education Program Evaluation Form
The Education Program Evaluation Form was developed by the researchers. The form consists of 17 items designed to assess participants' satisfaction with the program and their evaluations of the intervention process.
Measured: 1 week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start17 Apr 2026
- Primary completion18 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study was planned as a randomized controlled experimental design with a pretest-posttest.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahsa Tamaddon, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607847
- Sponsor's protocol ID
- 07/89
- Acronym
- Lifestyle
- Status last verified
- Apr 2026
- First submitted
- 19 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a PRECEDE-PROCEED Model-Based Health Education Program Integrated With Laughter Yoga on Adolescents' Healthy Lifestyle Behaviors
- ClinicalTrials.gov ID
- NCT07607847
- Acronym / sponsor ID
- Lifestyle / 07/89
- Conditions
- Health Behavior, Health Lifestyle Behaviors, Adolescent, Adolescent Behavior, Laughter Therapy, Precede Proceed Model
- Keywords
- Adolescents, School Health, Health Promotion, Healthy Lifestyle Behaviors, Laughter Yoga, PRECEDE-PROCEED Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 18 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized controlled trial designed to evaluate the effects of a PRECEDE-PROCEED Model-based laughter yoga-supported education program on adolescent health-related behaviors among 8th-grade students in a public middle school in Ankara, Türkiye.
The study was conducted in a socioeconomically disadvantaged district to ensure contextual relevance. A single middle school was selected using simple random sampling, and all eligible 8th-grade students were invited to participate. Participants who met the inclusion criteria and provided parental consent were randomly assigned to intervention and control groups in a 1:1 ratio using computer-generated randomization performed by an independent researcher. Allocation concealment was maintained until assignment. Due to the nature of the intervention, blinding of participants and intervention providers was not possible; however, outcome assessors and data analysts were blinded to group allocation.
The intervention group received a structured 6-week program based on the PRECEDE-PROCEED Model, consisting of weekly health education sessions combined with laughter yoga practices. Health education sessions included interactive materials and visual resources, while laughter yoga sessions were delivered by a certified researcher and included breathing techniques, group exercises, and relaxation activities. Educational materials were also shared with families to support reinforcement outside the school environment. The control group continued with the standard school curriculum and did not receive any intervention during the study period.
Data were collected at three time points: baseline, immediately after the 6-week intervention, and at 3-month follow-up. The intervention's short-term and medium-term effects were evaluated through standardized measurement tools assessing behavioral and psychosocial outcomes. After completion of data collection, a single-session educational activity was offered to the control group for ethical reasons.
Statistical analyses were performed using appropriate parametric and non-parametric tests based on data distribution. Group differences and changes over time were analyzed using repeated-measures approaches, and effect sizes were calculated to determine the magnitude of intervention effects. Statistical significance was set at p < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was planned as a randomized controlled experimental design with a pretest-posttest.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group:Laughter yoga-integrated health education | Experimental | Behavioral: Laughter yoga-integrated health educationStudents 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. |
| 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter yoga-integrated health educationA 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. | Behavioural | Intervention Group:Laughter yoga-integrated health education |
Primary outcome
Adolescent Lifestyle Profile Scale
Time frame: 1 week before intervention and 1 week post-intervention
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
Participant Information Form
Time frame: Baseline (1 week before intervention)
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.
1 secondary outcome
Education Program Evaluation Form
Time frame: 1 week post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter yoga-integrated health education in people with Health Behavior and Health Lifestyle Behaviors, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adolescent Lifestyle Profile Scale (time frame: 1 week before intervention and 1 week post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.