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Effects of Web-Based Adolescent Health Promotion Program in Hearing Impaired Adolescents (ASGE-FABES)

Primary Purpose

Health Promotion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Experimental group
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Health Promotion focused on measuring Hearing Impaired, Adolescent health, Health Promotion, Web-based, ASGE- FABES

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • who want to withdraw from the research

Sites / Locations

  • Istanbul University - Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

(Intervention group) Hearing impaired adolescent experimental group

(Control group) Hearing impaired adolescent control Group

Arm Description

Hearing Impaired Adolescent Group implemented Web-Based Adolescent Health Promotion Education Program

Hearing Impaired Adolescent Group that did not apply Web-Based Adolescent Health Promotion Education Program

Outcomes

Primary Outcome Measures

Physical Variables:
Body Mass Index (BMI- kg/m^2) and Weight (kg)

Secondary Outcome Measures

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
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.
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.
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).

Full Information

First Posted
January 19, 2022
Last Updated
April 8, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05329207
Brief Title
Effects of Web-Based Adolescent Health Promotion Program in Hearing Impaired Adolescents
Acronym
ASGE-FABES
Official Title
Effects of Web-Based Adolescent Health Promotion Program on Physical Activity, Nutrition and Mental Health in Hearing Impaired Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 18, 2022 (Anticipated)
Primary Completion Date
October 18, 2022 (Anticipated)
Study Completion Date
November 18, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Promotion
Keywords
Hearing Impaired, Adolescent health, Health Promotion, Web-based, ASGE- FABES

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was in the design type with pretest-posttest control group, repeated measures in randomized groups.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
(Intervention group) Hearing impaired adolescent experimental group
Arm Type
Experimental
Arm Description
Hearing Impaired Adolescent Group implemented Web-Based Adolescent Health Promotion Education Program
Arm Title
(Control group) Hearing impaired adolescent control Group
Arm Type
No Intervention
Arm Description
Hearing Impaired Adolescent Group that did not apply Web-Based Adolescent Health Promotion Education Program
Intervention Type
Behavioral
Intervention Name(s)
Experimental group
Other Intervention Name(s)
ASGE-FABES
Intervention Description
Web Based Adolescent Health Promotion Education Program
Primary Outcome Measure Information:
Title
Physical Variables:
Description
Body Mass Index (BMI- kg/m^2) and Weight (kg)
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Behavioral Variables:
Description
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
Time Frame
9 months
Title
Cognitive Variables 1:
Description
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.
Time Frame
9 months
Title
Cognitive Variables 2:
Description
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.
Time Frame
9 months
Title
Cognitive Variables 3:
Description
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).
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: who want to withdraw from the research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HAKAN ORAKCI, Phd Student
Phone
+905053878162
Email
hakanorakci@yyu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AYSUN ARDIÇ, Assoc. Prof.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University - Cerrahpasa
City
İstanbul
State/Province
Avcılar
ZIP/Postal Code
34320
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Web-Based Adolescent Health Promotion Program in Hearing Impaired Adolescents

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