Health PromotionASGE-FABESNCT05329207
Effects of Web-Based Adolescent Health Promotion Program in Hearing Impaired Adolescents
A study testing Experimental group in people with Health Promotion, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Our research is to evaluate the effect and applicability of the adolescent health promotion program, which includes multiple behavioral interventions, on physical activity, nutrition and mental health of hearing impaired adolescents living in the community. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Health Promotion
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Apr 2022to 18 Nov 2022
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hearing impairment,
- In the 12-18 age group,
- Ability to access communication tools such as computers, tablets and smartphones and use the internet with these tools,
- Able to communicate in visual, sign language and written,
- Does not have a physical condition or disease that may prevent exercise,
- Volunteer to participate in the research,
- Permitted to participate in the research by their parents.
Who cannot join
- who want to withdraw from the research
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University - Cerrahpasa
Istanbul, Avcılar, 34320
About this study
Official title: Effects of Web-Based Adolescent Health Promotion Program on Physical Activity, Nutrition and Mental Health in Hearing Impaired Adolescents
Our research is to evaluate the effect and applicability of the adolescent health promotion program, which includes multiple behavioral interventions, on physical activity, nutrition and mental health of hearing impaired adolescents living in the community.
Read the detailed description
Purpose of the research; To evaluate the effect and applicability of the Web-Based Adolescent Health Promotion program, which includes multiple health behavior initiatives, on physical activity, nutrition, and stress management of hearing impaired adolescents in making healthy choices, assuming their own health responsibilities and acquiring healthy lifestyle behaviors.
Materials and methods; The research is a full experimental study with pretest-posttest control group, repeated measurement design, random groups.
Research sample; A total of 70 hearing-impaired adolescents aged 12-18, studying at Abdurrahman Gazi Sağlar Primary School, Van Special Education Vocational High School and Duyus Special Education and Rehabilitation Center affiliated to the Ministry of National Education in the city center of Van.
The data of the research; "Sociodemographic Characteristics Information Form", "Body Mass Index (BMI)", "Adolescent Nutrition Information Scale", "Adolescent Physical Activity Information Scale", "Adolescent Lifestyle Scale", "Adolescent Healthy Lifestyle Choices Scale", "Renewed Child" Anxiety and Depression Scale", "Daily Food Consumption Form", "Beverage Consumption Form", "Pedometer" were collected.
In the study; descriptive statistics will be evaluated with mean, standard deviation, percentage and frequency analysis. Comparisons between groups will be analyzed using Pearson's chi-square, Student's t-test, Mann Whitney-U test, Kruskal Wallis test, analysis of variance and Cohen's d effect size.
The results of this study;
- Physical Variables: Body Mass Index (BMI) and Weight
- Behavioral Variables: Weekly average number of steps and change, fruit and vegetable consumption amount, amount of water consumed, amount of sugary and acidic beverages consumed, "Adolescent Lifestyle" scale score average, "Adolescent" Lifestyle Choices scale score average,
- Cognitive Variables: "Adolescent Nutrition Knowledge" scale mean score, "Adolescent Physical Activity Knowledge" scale mean score, "Regenerated Child Anxiety and Depression" scale mean score will be evaluated.
- Conditions
- Health Promotion
- Being tested
- Experimental group
- Keywords
- Hearing Impaired, Adolescent health, Health Promotion, Web-based, ASGE- FABES
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupBehavioural
Also called ASGE-FABES
Web Based Adolescent Health Promotion Education Program
| Study group | Role | What they receive |
|---|---|---|
| (Intervention group) Hearing impaired adolescent experimental group | Experimental | Hearing Impaired Adolescent Group implemented Web-Based Adolescent Health Promotion Education Program Receives: Behavioral: Experimental group |
| (Control group) Hearing impaired adolescent control Group | No intervention | Hearing Impaired Adolescent Group that did not apply Web-Based Adolescent Health Promotion Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Variables:
Body Mass Index (BMI- kg/m^2) and Weight (kg)
Measured: 9 months
Secondary outcomes (4)
Behavioral Variables:
The mean score of "Adolescent Lifestyle Scale" is used for behavioral change;
- The scale requires a 4-point Likert-type response for each item. 1 for "Never", 2 for "Sometimes", 3 for "Often" and 4 for "Always"
- The maximum score obtained from the scale is 160 and the minimum score is 40.
- The scale does not have a cut-off point, as the score increases, the level of positive health behavior increases
Measured: 9 months
Cognitive Variables 1:
The mean score of "Adolescent Nutrition Knowledge Scale" will be evaluated.
Scoring
- Highlighted answer is correct
- Recode items
- If answer don't know (2), recode as no (0)
- If answer is correct, recode as (1)
- If answer is incorrect, recode as (0)
- After recoding, sum items 1-12
- Summed total will reflect the number of items answered correctly.
Measured: 9 months
Cognitive Variables 2:
The mean score of "Adolescent Physical Activity Knowledge Scale" will be evaluated.
Scoring
- Highlighted answer is correct
- Recode items
- If answer don't know (2), recode as no (0)
- If answer is correct, recode as (1)
- If answer is incorrect, recode as (0)
- After recoding, sum items 1-12
- Summed total will reflect the number of items answered correctly.
Measured: 9 months
Cognitive Variables 3:
The mean score of "Regenerated Child Anxiety and Depression Scale" will be evaluated.
The RCADS consists of 47 items developed to measure DSM-IV based symptoms of anxiety disorders and depression in children and adolescents.
The subscales correspond to SAD (7 items), SP (9 items), GAD (6 items), PD (9 items), OCD (6 items), and MDD (10 items).
It is scored on a 4-point scale (0 =never, 1 = sometimes, 2 = often, and 3 = always).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start18 Apr 2022 (estimated)
- Primary completion18 Oct 2022 (estimated)
- Study completion18 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was in the design type with pretest-posttest control group, repeated measures in randomized groups.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakan ORAKCI, Istanbul University - Cerrahpasa
- Investigators
- AYSUN ARDIÇ, Assoc. Prof., Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05329207
- Sponsor's protocol ID
- HAKAN ORAKCI PHD THESIS
- Acronym
- ASGE-FABES
- Status last verified
- Apr 2022
- First submitted
- 19 Jan 2022
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orakci H, Ardic A. The effect of web-based cope healthy lifestyles TEEN program on hearing-impaired adolescents: A randomized controlled trial. J Pediatr Nurs. 2026 Jan-Feb;86:590-602. doi: 10.1016/j.pedn.2025.12.006. Epub 2025 Dec 18.
PubMed 41418421
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Web-Based Adolescent Health Promotion Program on Physical Activity, Nutrition and Mental Health in Hearing Impaired Adolescents
- ClinicalTrials.gov ID
- NCT05329207
- Acronym / sponsor ID
- ASGE-FABES / HAKAN ORAKCI PHD THESIS
- Conditions
- Health Promotion
- Keywords
- Hearing Impaired, Adolescent health, Health Promotion, Web-based, ASGE- FABES
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 Apr 2022 (estimated)
- Primary completion
- 18 Oct 2022 (estimated)
- Study completion
- 18 Nov 2022 (estimated)
- First posted
- 14 Apr 2022 (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.
Our research is to evaluate the effect and applicability of the adolescent health promotion program, which includes multiple behavioral interventions, on physical activity, nutrition and mental health of hearing impaired adolescents living in the community.
Detailed description
Purpose of the research; To evaluate the effect and applicability of the Web-Based Adolescent Health Promotion program, which includes multiple health behavior initiatives, on physical activity, nutrition, and stress management of hearing impaired adolescents in making healthy choices, assuming their own health responsibilities and acquiring healthy lifestyle behaviors.
Materials and methods; The research is a full experimental study with pretest-posttest control group, repeated measurement design, random groups.
Research sample; A total of 70 hearing-impaired adolescents aged 12-18, studying at Abdurrahman Gazi Sağlar Primary School, Van Special Education Vocational High School and Duyus Special Education and Rehabilitation Center affiliated to the Ministry of National Education in the city center of Van.
The data of the research; "Sociodemographic Characteristics Information Form", "Body Mass Index (BMI)", "Adolescent Nutrition Information Scale", "Adolescent Physical Activity Information Scale", "Adolescent Lifestyle Scale", "Adolescent Healthy Lifestyle Choices Scale", "Renewed Child" Anxiety and Depression Scale", "Daily Food Consumption Form", "Beverage Consumption Form", "Pedometer" were collected.
In the study; descriptive statistics will be evaluated with mean, standard deviation, percentage and frequency analysis. Comparisons between groups will be analyzed using Pearson's chi-square, Student's t-test, Mann Whitney-U test, Kruskal Wallis test, analysis of variance and Cohen's d effect size.
The results of this study;
- Physical Variables: Body Mass Index (BMI) and Weight
- Behavioral Variables: Weekly average number of steps and change, fruit and vegetable consumption amount, amount of water consumed, amount of sugary and acidic beverages consumed, "Adolescent Lifestyle" scale score average, "Adolescent" Lifestyle Choices scale score average,
- Cognitive Variables: "Adolescent Nutrition Knowledge" scale mean score, "Adolescent Physical Activity Knowledge" scale mean score, "Regenerated Child Anxiety and Depression" scale mean score will be evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study was in the design type with pretest-posttest control group, repeated measures in randomized groups.
| Arm | Type | Receives |
|---|---|---|
| (Intervention group) Hearing impaired adolescent experimental group | Experimental | Behavioral: Experimental groupHearing Impaired Adolescent Group implemented Web-Based Adolescent Health Promotion Education Program |
| (Control group) Hearing impaired adolescent control Group | No intervention | –Hearing Impaired Adolescent Group that did not apply Web-Based Adolescent Health Promotion Education Program |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Hearing impairment,
- In the 12-18 age group,
- Ability to access communication tools such as computers, tablets and smartphones and use the internet with these tools,
- Able to communicate in visual, sign language and written,
- Does not have a physical condition or disease that may prevent exercise,
Key exclusion criteria (1 listed)
- who want to withdraw from the research
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 |
|---|---|---|
| Experimental groupAlso: ASGE-FABESWeb Based Adolescent Health Promotion Education Program | Behavioural | (Intervention group) Hearing impaired adolescent experimental group |
Primary outcome
Physical Variables:
Time frame: 9 months
Body Mass Index (BMI- kg/m^2) and Weight (kg)
4 secondary outcomes
Behavioral Variables:
Time frame: 9 months
Cognitive Variables 1:
Time frame: 9 months
Cognitive Variables 2:
Time frame: 9 months
Cognitive Variables 3:
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Derived from this study: PubMed 41418421Orakci H, Ardic A. The effect of web-based cope healthy lifestyles TEEN program on hearing-impaired adolescents: A randomized controlled trial. J Pediatr Nurs. 2026 Jan-Feb;86:590-602. doi: 10.1016/j.pedn.2025.12.006. Epub 2025 Dec 18.
- 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.
AYSUN ARDIÇ, Assoc. Prof. study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Health Promotion, run by Istanbul University - Cerrahpasa 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 7 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HAKAN ORAKCI, Phd Student (+905053878162, hakanorakci@yyu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Variables: (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05329207, which also lists 1 linked publication.
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 14 Apr 2022.