NCT04149756

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\[clinicaltrial.gov;NCT03675191\]).

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

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

Study Start

First participant enrolled

April 17, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

7 months

First QC Date

October 31, 2019

Last Update Submit

November 1, 2019

Conditions

Weight Reduction

Outcome Measures

Primary Outcomes (1)

  • weight

    weight changes

    after 6months

Secondary Outcomes (1)

  • lipid profile

    after 6months

Study Arms (1)

overweight or obese adults

overweight or obese adults who participate the trial (NCT03675191)

Other: observation of weight after 6months

Interventions

observation of weight after 6monthsOTHER

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. .

overweight or obese adults

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Those who have withdrawn the previous trial (NCT03675191)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongin Severance hospital

Yongin, Gyeonggi-do, 17046, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood 20ml, serum, plasma, peripheral blood mononuclear cell

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yu-Jin Kwon, Dr

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji-Won Lee, PhD

CONTACT

02-2019-3480indi5645@yuhs.ac

Yu-Jin Kwon, Dr

CONTACT

031-331-8710digda3@yuhs.ac

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

April 17, 2019

Primary Completion

October 30, 2019

Study Completion

November 30, 2019

Last Updated

November 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)