Obesity PreventionNCT06804031
Adolescents' Health Literacy, Physical Activity and Healthy Eating Self-efficacy Levels
A study testing Nutrition and exercise education in people with Obesity Prevention and Exercise, run by Adem SÜMEN at 1 site in Turkey (Türkiye).
Trial summary
Adolescence is a critical transitional period characterized by rapid and multifaceted changes in physical, psychological, and social dimensions. According to the World Health Organization, adolescence encompasses the age range of 10 to 19 years. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity Prevention, Exercise, Nutrition
- What is being tested?
- Nutrition and exercise education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 15 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- - Volunteering to participate in the research
- Being allowed to participate in the study by their parents
- No physical or mental disabilities and chronic diseases (diabetes, metabolic syndrome, heart disease, etc.)
Who cannot join
- - Incomplete completion of research data collection forms
- Declining to participate in the research
- Failure to complete at least 5 health education sessions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutrition and Exercise Education Given to Middle School Students on Adolescents' Health Literacy, Physical Activity and Healthy Eating Self-efficacy Levels: A Randomized Controlled Trial
Adolescence is a critical transitional period characterized by rapid and multifaceted changes in physical, psychological, and social dimensions. According to the World Health Organization, adolescence encompasses the age range of 10 to 19 years. Alongside physical changes, this period involves significant developments and transformations in knowledge, skills, and behaviors, driven by the individual's identity formation process. Health behaviors such as nutrition and physical activity play a pivotal role in protecting and promoting adolescent health. However, unhealthy eating habits and insufficient physical activity are highly prevalent among adolescents.
These behaviors are associated with physical problems, including obesity, diabetes, hypertension, cardiovascular diseases, delayed growth and development, and psychological issues such as susceptibility to stress, low self-esteem, and lack of confidence. Consequently, fostering healthy eating and physical activity behaviors in adolescents is essential.
Read more
Given that adolescents spend a considerable portion of their time in school, implementing school-based interventions to promote these behaviors represents an effective approach to preventing lifestyle-related health issues in adulthood. The literature indicates that various interventions aimed at improving nutrition and physical activity behaviors in adolescents are generally effective. Nevertheless, sustaining these behaviors in the long term remains a challenge, as studies have shown that increases in knowledge do not always translate into behavioral changes.
One of the most effective strategies for instilling healthy behaviors in adolescents is health education. School-based health education not only facilitates the acquisition of functional health literacy but also strengthens the attitudes, beliefs, and practical skills necessary for adopting and maintaining healthy behaviors. Moreover, health education is a powerful tool for enhancing health literacy components such as accessing, understanding, evaluating, and utilizing accurate health information, enabling adolescents to take responsibility for their health and make informed decisions.
This study aims to contribute to fostering healthy eating and physical activity behaviors in adolescents, supporting their transformation into lifelong habits. Additionally, the findings are expected to guide school health professionals, particularly school nurses, in expanding interventions within the scope of school health services.
- Conditions
- Obesity Prevention, Exercise, Nutrition, Health Literacy, Physical Activity, Self-Efficacy
- Being tested
- Nutrition and exercise education
- Keywords
- adolesence, nutrition, exercise, health literacy, physical activity, healthy eating, self-efficacy
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and exercise educationBehavioural
Nutrition and exercise training was created as a result of literature review, and expert opinions (Public Health Nursing, Pediatric Nursing, Physical Therapy and Rehabilitation, Nutrition and Dietetics) were taken for the training content and finalized. The training program consists of six sessions. It is planned to have one session per week and each session will last 30-45 minutes on average. The times when the students are available will be determined by discussing with the school administration in advance. Computers and barcovisions in schools will be utilized for the training of students. Trainings will be conducted through verbal expression, power point presentations, brainstorming, exercises, games, written and visual materials, video screenings and question-answer methods. Adolescents will be given bookmarks, magnets and brochures prepared to prevent obesity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Behavioral: Nutrition and exercise education |
| Control group | No intervention | Not described |
| Control group 2 | No intervention | At the end of the research, the data of control group I and control group II will be compared to evaluate whether there is an interaction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Literacy Scale for School-Age Children
The health literacy scale for school-age children was developed to assess the health literacy of school-age children. The scale consists of 10 items and one dimension. The total score is between 10 and 40. The total score obtained from the scale (10-25 points) defines low health literacy, (26-35 points) medium health literacy, (36-40 points) high health literacy.
Measured: 5-6 month
Physical Activity Self-Efficacy Scale for Children
It will be used to measure physical activity self-efficacy. The scale consists of 9 items. The score that can be obtained from the scale varies between 9-27, and the higher the score, the lower the strength of physical activity self-efficacy.
Measured: 5-6 month
Healthy Eating Self-Efficacy Scale for Children
It was studied to be used in the assessment of children's self-efficacy for healthy eating. The scale consists of 9 items and one dimension. Participants can score between 0 and 18 points on the scale. The higher the scale score, the higher the self-efficacy for healthy eating.
Measured: 5-6 month
Secondary outcomes (2)
Adolescent Health Promotion Scale - Nutrition and Exercise Subscale
The scale was developed to assess the level of health promotion behavior of adolescents. The total score that can be obtained from the scale varies between 6-30 for the nutrition sub-dimension and between 4-20 for the exercise sub-dimension. A high total score in the nutrition subscale indicates that adolescents have positive nutrition behaviors, and a high total score in the exercise subscale indicates that adolescents have positive exercise behaviors.
Measured: 5-6 month
Nutrition-Exercise Attitude Scale
The nutrition-exercise attitude scale was developed to evaluate the nutrition-exercise attitudes of adolescents. The total score that can be obtained from the scale varies between 13 and 65. A high total score indicates a positive attitude towards nutrition-exercise, while a low score indicates negative attitudes towards nutrition-exercise.
Measured: 5-6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Mar 2025
- Primary completion15 Mar 2025
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity PreventionStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adem SÜMEN
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of National Education, Turkey
- Responsible party
- Sponsor-investigator, Adem SÜMEN, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804031
- Sponsor's protocol ID
- TBAEK-591
- Status last verified
- Apr 2025
- First submitted
- 27 Jan 2025
- Last updated
- 16 Apr 2025
- 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 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Exercise Education Given to Middle School Students on Adolescents' Health Literacy, Physical Activity and Healthy Eating Self-efficacy Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06804031
- Acronym / sponsor ID
- TBAEK-591
- Conditions
- Obesity Prevention, Exercise, Nutrition, Health Literacy, Physical Activity, Self-Efficacy
- Keywords
- adolesence, nutrition, exercise, health literacy, physical activity, healthy eating, self-efficacy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Adem SÜMENUniversity, hospital or other
- Collaborators
- Ministry of National Education, Turkey
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 31 Jan 2025 (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 transitional period characterized by rapid and multifaceted changes in physical, psychological, and social dimensions. According to the World Health Organization, adolescence encompasses the age range of 10 to 19 years. Alongside physical changes, this period involves significant developments and transformations in knowledge, skills, and behaviors, driven by the individual's identity formation process. Health behaviors such as nutrition and physical activity play a pivotal role in protecting and promoting adolescent health. However, unhealthy eating habits and insufficient physical activity are highly prevalent among adolescents.
These behaviors are associated with physical problems, including obesity, diabetes, hypertension, cardiovascular diseases, delayed growth and development, and psychological issues such as susceptibility to stress, low self-esteem, and lack of confidence. Consequently, fostering healthy eating and physical activity behaviors in adolescents is essential.
Given that adolescents spend a considerable portion of their time in school, implementing school-based interventions to promote these behaviors represents an effective approach to preventing lifestyle-related health issues in adulthood. The literature indicates that various interventions aimed at improving nutrition and physical activity behaviors in adolescents are generally effective. Nevertheless, sustaining these behaviors in the long term remains a challenge, as studies have shown that increases in knowledge do not always translate into behavioral changes.
One of the most effective strategies for instilling healthy behaviors in adolescents is health education. School-based health education not only facilitates the acquisition of functional health literacy but also strengthens the attitudes, beliefs, and practical skills necessary for adopting and maintaining healthy behaviors. Moreover, health education is a powerful tool for enhancing health literacy components such as accessing, understanding, evaluating, and utilizing accurate health information, enabling adolescents to take responsibility for their health and make informed decisions.
This study aims to contribute to fostering healthy eating and physical activity behaviors in adolescents, supporting their transformation into lifelong habits. Additionally, the findings are expected to guide school health professionals, particularly school nurses, in expanding interventions within the scope of school health services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Nutrition and exercise education |
| Control group | No intervention | – |
| Control group 2 | No intervention | –At the end of the research, the data of control group I and control group II will be compared to evaluate whether there is an interaction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- - Volunteering to participate in the research
- Being allowed to participate in the study by their parents
- No physical or mental disabilities and chronic diseases (diabetes, metabolic syndrome, heart disease, etc.)
Key exclusion criteria (3 listed)
- - Incomplete completion of research data collection forms
- Declining to participate in the research
- Failure to complete at least 5 health education sessions
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 |
|---|---|---|
| Nutrition and exercise educationNutrition and exercise training was created as a result of literature review, and expert opinions (Public Health Nursing, Pediatric Nursing, Physical Therapy and Rehabilitation, Nutrition and Dietetics) were taken for the training content and finalized. The training program consists of six sessions. It is planned to have one session per week and each session will last 30-45 minutes on average. The times when the students are available will be determined by discussing with the school administration in advance. Computers and barcovisions in schools will be utilized for the training of students. Trainings will be conducted through verbal expression, power point presentations, brainstorming, exercises, games, written and visual materials, video screenings and question-answer methods. Adolescents will be given bookmarks, magnets and brochures prepared to prevent obesity. | Behavioural | Experimental group |
Primary outcome
Health Literacy Scale for School-Age Children
Time frame: 5-6 month
The health literacy scale for school-age children was developed to assess the health literacy of school-age children. The scale consists of 10 items and one dimension. The total score is between 10 and 40. The total score obtained from the scale (10-25 points) defines low health literacy, (26-35 points) medium health literacy, (36-40 points) high health literacy.
Physical Activity Self-Efficacy Scale for Children
Time frame: 5-6 month
It will be used to measure physical activity self-efficacy. The scale consists of 9 items. The score that can be obtained from the scale varies between 9-27, and the higher the score, the lower the strength of physical activity self-efficacy.
Healthy Eating Self-Efficacy Scale for Children
Time frame: 5-6 month
It was studied to be used in the assessment of children's self-efficacy for healthy eating. The scale consists of 9 items and one dimension. Participants can score between 0 and 18 points on the scale. The higher the scale score, the higher the self-efficacy for healthy eating.
2 secondary outcomes
Adolescent Health Promotion Scale - Nutrition and Exercise Subscale
Time frame: 5-6 month
Nutrition-Exercise Attitude Scale
Time frame: 5-6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Obesity Prevention
Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Recruiting
Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort
Joint Osteoarthritis, Atherosclerosis of the Distal Arteries, Without Gangrene
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 3
Weight Gain Prevention in Adolescents and Young Adults
Healthy Volunteers
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 Nutrition and exercise education in people with Obesity Prevention and Exercise, run by Adem SÜMEN 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Health Literacy Scale for School-Age Children (time frame: 5-6 month). The study lists 3 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 Apr 2025.