Persistent Weight Maintenance for 6 Months After 3 Months... | NCT04149756

Studies
Persistent Weight Maintenance for 6 Months After 3 Months of Active Weight Loss

NCT04149756

Sponsor

Gangnam Severance Hospital

Status

Unknown status

Last Update Posted

Nov 4, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Weight Reduction

Interventions

observation of weight after 6months

Countries

South Korea

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

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2019Actual

Primary Completion Date

Oct 30, 2019Estimated

Completion Date

Nov 30, 2019Estimated

First Submitted Date

Oct 31, 2019

First Submission Date that Met QC Criteria

Nov 1, 2019

First Posted Date

Nov 4, 2019Actual

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

Nov 1, 2019

Last Update Posted Date

Nov 4, 2019Actual

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

This study is intended to report changes in the weight and metabolic indicators of the subjects six months after the end of the study for adults with a risk factor of 27 kg/m2 or higher (formerly the research task name[clinicaltrial.gov;NCT03675191]).

Detailed Description

There was no special intervention after the previous research intervention. After the previous research was completed, we will check the changes in the body composition and metabolic indicators over six months.

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

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
overweight or obese adults		overweight or obese adults who participate the trial (NCT03675191)	Other: observation of weight after 6months

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observation of weight after 6months	Other	This study is an observational study for 96 people who have completed the previous weight loss program. We will check the body composition and lipid profile of the participants who voluntarily visit after 6months after the end of the study. .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
weight	weight changes	after 6months

Secondary Outcomes

Measure	Description	Time Frame
lipid profile	total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride	after 6months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Those who have participated in the previous trial (NCT03675191) and have completed the three-month study
Those who agreed the trial.

Exclusion Criteria:

Those who have withdrawn the previous trial (NCT03675191)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Body mass index (BMI) more than 27kg/m2 with comorbidities or BMI more than 30kg/m2

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ji-Won Lee, PhD	Contact	02-2019-3480		indi5645@yuhs.ac
Yu-Jin Kwon, Dr	Contact	031-331-8710		digda3@yuhs.ac

Overall Officials

Name	Affiliation	Role
Yu-Jin Kwon, Dr	Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yongin Severance hospital	Recruiting	Yongin	Gyeonggi-do	17046	South Korea

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
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided