NCT05329207

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2022

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

6 months

First QC Date

January 19, 2022

Last Update Submit

April 8, 2022

Conditions

Keywords

Hearing ImpairedAdolescent healthHealth PromotionWeb-basedASGE- FABES

Outcome Measures

Primary Outcomes (1)

  • Physical Variables:

    Body Mass Index (BMI- kg/m\^2) and Weight (kg)

    9 months

Secondary Outcomes (4)

  • Behavioral Variables:

    9 months

  • Cognitive Variables 1:

    9 months

  • Cognitive Variables 2:

    9 months

  • Cognitive Variables 3:

    9 months

Study Arms (2)

(Intervention group) Hearing impaired adolescent experimental group

EXPERIMENTAL

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

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

Interventions

Web Based Adolescent Health Promotion Education Program

Also known as: ASGE-FABES
(Intervention group) Hearing impaired adolescent experimental group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • who want to withdraw from the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Avcılar, 34320, Turkey (Türkiye)

Location

Related Publications (1)

  • 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. 2025 Dec 18;86:590-602. doi: 10.1016/j.pedn.2025.12.006. Online ahead of print.

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • AYSUN ARDIÇ, Assoc. Prof.

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Central Study Contacts

HAKAN ORAKCI, Phd Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was in the design type with pretest-posttest control group, repeated measures in randomized groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

January 19, 2022

First Posted

April 14, 2022

Study Start

April 18, 2022

Primary Completion

October 18, 2022

Study Completion

November 18, 2022

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations