Health Literacy LevelNCT05677854
The Effect of Health Literacy Based Practices
A study testing Health literacy based motivaonal interview and Health literacy based health education in people with Health Literacy Level, run by Ayşegül Akca at 1 site in Turkey (Türkiye).
Trial summary
It is important to adopt healthy lifestyle behaviors such as nutrition and physical activity in adolescence. Health literacy, which is the competence of adolescents to participate in their own health decisions and takes responsibility for health, needs to be developed. Read more about this study
- Who is it for?
- Ages 14 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Literacy Level
- What is being tested?
- Health literacy based motivaonal interview and Health literacy based health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 26 Sep 2023
- 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 14 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Continuing education in 9th grade
- Volunteering to participate in the research
- Permission by their families to participate in the research
- Being at a low or moderate level of health literacy according to the Health Literacy Scale for School-Age Children
Who cannot join
- Have a chronic illness
- Dieting within a program
- Doing regular physical activity
- Having a high level of health literacy according to the Health Literacy Scale for School-Age Children
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, Çubuk/Türkiye, 06760
About this study
Official title: The Effect of Health Literacy Based Motivational Interviewing and Health Education on Nutrition and Physical Activity Behaviors of Adolescents
It is important to adopt healthy lifestyle behaviors such as nutrition and physical activity in adolescence. Health literacy, which is the competence of adolescents to participate in their own health decisions and takes responsibility for health, needs to be developed. Developing healthy nutrition and physical activity behaviors with a focus on health literacy is important in terms of maintaining the desired behavior in adulthood. This study aims to examine the effects of health literacy-based motivational interviewing and health education on nutrition and exercise behaviors of adolescents. The research will be conducted with a single-blind randomized controlled experimental design. The population of the research consists of ninth-grade students. It is planned to include 72 people in the research sample according to the power analysis calculation. The research will be carried out with two intervention groups as motivational interview and health education and a control group.
- Conditions
- Health Literacy Level
- Being tested
- Health literacy based motivaonal interview, Health literacy based health education
- Keywords
- health literacy, motivational interview, health education, nutrition, physical activity, adolescent
- Medical subject headings
- Health Education, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy based motivaonal interviewOther
Motivational interviewing technique was used based on health literacy.
Health literacy based health educationOther
Health education based on health literacy was used.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interview | Experimental | Motivational interviewing, consisting of 6 sessions with a one-week interval, was applied face to face to this intervention group. Each motivational interview lasted approximately 40 minutes. Receives: Other: Health literacy based motivaonal interview |
| Health education | Experimental | Health education consisting of 6 sessions, one week apart, was administered face to face to this intervention group. Each training session lasted approximately 40 minutes. Receives: Other: Health literacy based health education |
| Control | No intervention | No intervention has been made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy level (Health Literacy Scale for School-Age Children)
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy. By determining the health literacy level of the students, the intervention groups and the control group will be selected among the students with low and moderate health literacy levels.
Measured: before the implementation
Health literacy level (Health Literacy Scale for School-Age Children)
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy. By determining the health literacy level of the students, the intervention groups and the control group will be selected among the students with low and moderate health literacy levels.
Measured: after the implementation
Health literacy level (Health Literacy Scale for School-Age Children)
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy.
Measured: three months after completion of the intervention
Health literacy level (Health Literacy Scale for School-Age Children)
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy.
Measured: six months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Dec 2022
- Primary completion15 Jul 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Literacy LevelStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayşegül Akca
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Ayşegül Akca, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677854
- Sponsor's protocol ID
- 2022 - 042
- Status last verified
- Feb 2024
- First submitted
- 29 Dec 2022
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Health Literacy Based Motivational Interviewing and Health Education on Nutrition and Physical Activity Behaviors of Adolescents
- ClinicalTrials.gov ID
- NCT05677854
- Acronym / sponsor ID
- 2022 - 042
- Conditions
- Health Literacy Level
- Keywords
- health literacy, motivational interview, health education, nutrition, physical activity, adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ayşegül AkcaUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 10 Jan 2023 (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.
It is important to adopt healthy lifestyle behaviors such as nutrition and physical activity in adolescence. Health literacy, which is the competence of adolescents to participate in their own health decisions and takes responsibility for health, needs to be developed. Developing healthy nutrition and physical activity behaviors with a focus on health literacy is important in terms of maintaining the desired behavior in adulthood. This study aims to examine the effects of health literacy-based motivational interviewing and health education on nutrition and exercise behaviors of adolescents. The research will be conducted with a single-blind randomized controlled experimental design. The population of the research consists of ninth-grade students. It is planned to include 72 people in the research sample according to the power analysis calculation. The research will be carried out with two intervention groups as motivational interview and health education and a control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational interview | Experimental | Other: Health literacy based motivaonal interviewMotivational interviewing, consisting of 6 sessions with a one-week interval, was applied face to face to this intervention group. Each motivational interview lasted approximately 40 minutes. |
| Health education | Experimental | Other: Health literacy based health educationHealth education consisting of 6 sessions, one week apart, was administered face to face to this intervention group. Each training session lasted approximately 40 minutes. |
| Control | No intervention | –No intervention has been made. |
Who may qualify
- Ages
- 14 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Continuing education in 9th grade
- Volunteering to participate in the research
- Permission by their families to participate in the research
- Being at a low or moderate level of health literacy according to the Health Literacy Scale for School-Age Children
Key exclusion criteria (4 listed)
- Have a chronic illness
- Dieting within a program
- Doing regular physical activity
- Having a high level of health literacy according to the Health Literacy Scale for School-Age Children
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 |
|---|---|---|
| Health literacy based motivaonal interviewMotivational interviewing technique was used based on health literacy. | Other | Motivational interview |
| Health literacy based health educationHealth education based on health literacy was used. | Other | Health education |
Primary outcome
Health literacy level (Health Literacy Scale for School-Age Children)
Time frame: before the implementation
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy. By determining the health literacy level of the students, the intervention groups and the control group will be selected among the students with low and moderate health literacy levels.
Health literacy level (Health Literacy Scale for School-Age Children)
Time frame: after the implementation
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy. By determining the health literacy level of the students, the intervention groups and the control group will be selected among the students with low and moderate health literacy levels.
Health literacy level (Health Literacy Scale for School-Age Children)
Time frame: three months after completion of the intervention
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy.
Health literacy level (Health Literacy Scale for School-Age Children)
Time frame: six months after completion of the intervention
The level of health literacy was evaluated in three categories according to the score obtained: (10-25) points: low health literacy, (26-35) points: moderate health literacy and (36-40) points: high health literacy.
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 8 Jul 2024.
- 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 Health literacy based motivaonal interview and Health literacy based health education in people with Health Literacy Level, run by Ayşegül Akca 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 4 inclusion and 4 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 8 Jul 2024. 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?
Health literacy level (Health Literacy Scale for School-Age Children) (time frame: before the implementation). The study lists 4 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 8 Jul 2024.