The Effect of Mobile Application Supported Health Promoti... | NCT06427525

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 14, 2024Actual

Primary Completion Date

Apr 14, 2024Actual

Completion Date

May 1, 2024Actual

First Submitted Date

Oct 7, 2023

First Submission Date that Met QC Criteria

May 18, 2024

First Posted Date

May 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 16, 2024

Last Update Posted Date

Jul 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cumali Yıldızdal, Principal Investigator, Istanbul University - CerrahpasaPrincipal Investigator

Lead Sponsor

Istanbul University - CerrahpasaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

The aim of the study is to evaluate the effectiveness of the Child Obesity Program (COP), which is a school-based, parent-based, weight management program aimed mobile application at preventing overweight and obesity in childhood. The program aims to provide children with positive health behaviors, gain cognitive and behavioral skills that will enable them to increase their knowledge of physical activity, nutrition and stress management.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	mobile application at preventing overweight and obesity in childhood	Other: Mobile application-based adolecent obesity education
Control group	No Intervention	health education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mobile application-based adolecent obesity education	Other	Mobile application-based adolecent obesity education	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healthy Lifestyle Behaviors Scale	higher scores mean a better	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obesity Adolescents, smartphone internet, 10-16 years old

Exclusion Criteria:

non-obese child, 17 years old

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cumali Yıldızdal, phd student	Istanbul University - Cerrahpasa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florance Nightingale Nursing Faculty		Istanbul		34000	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D009043	Motor Activity
D015362	Child Nutrition Disorders

ID	Term
D001519	Behavior
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases