Application of Smart Devices in Adolescent Weight Control | NCT04760587

Studies
Application of Smart Devices in Adolescent Weight Control

NCT04760587

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jan 23, 2023Actual

Enrollment

108Actual

Phase

Not provided

Conditions

Adolescent Obesity

Interventions

smart devices in adolescent weight control

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

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

Jun 17, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Feb 17, 2021

First Submission Date that Met QC Criteria

Feb 17, 2021

First Posted Date

Feb 18, 2021Actual

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

Jan 20, 2023

Last Update Posted Date

Jan 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

According to the definition of Health Literacy, health literacy means that a person can apply his or her reading, writing, and computing abilities to health-related information and activities. WHO consider Health Literacy is the cognitive and social skills which determine the motivation and ability of individuals to gain access, to understand and use information.

The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.

Detailed Description

The purposes of this study will to understand the relationship between health literacy, weight control behavior and weight control health outcome.

According to the purpose, the study will be multi wave longitudinal panel study. The study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent.

There are two blocks in the mobile phone applications: questionnaire block and Weight status block will be design for the study. Questionnaire block include demography, and health literacy scales and diet diary. Weight status block include height, weight, waist circumference, and hip circumference. After the participant key-in the height and weight, the system will automatically calculate the BMI, also show the results of the BMI. The standard for BMI interpretation was by Dr. Chang's research about New Growth Charts for Taiwanese Adolescents.

The data of smart watches will be upload into the NTUH health cloud system (named NTU MED GOD). This is the NTUH health cloud, different kinds of medical materials and data could be sent to the system, such as mobile phone and smart watches data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group		smart devices in adolescent	Behavioral: smart devices in adolescent weight control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
smart devices in adolescent weight control	Behavioral	The study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BMI(body mass index)	Body mass index (BMI) is a measure of body fat based on height and weight.	Change from baseline body mass index at 3 months, 6 months, 9 months, and 12 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

13-19 years old adolescents;
Could use their mobile phones to upload diet records and fill out the questionnaire;
Adolescents and their parents agree to involve in the study and sign the consent form.

Exclusion Criteria:

Severe diseases;
Participate in other weight control program.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

The study in this study will be 13-19 years old adolescents.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yu-Hsia Chen	National Taiwan University, College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

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

Condition Browse Module

MeSH Terms

ID	Term
D063766	Pediatric Obesity

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided