Weight ReductionNCT04149756
Persistent Weight Maintenance for 6 Months After 3 Months of Active Weight Loss
An observational study of Weight Reduction, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial 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]). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Weight Reduction
- What is being tested?
- observation of weight after 6months
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Apr 2019to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Body mass index (BMI) more than 27kg/m2 with comorbidities or BMI more than 30kg/m2
Who may be able to join
- Those who have participated in the previous trial (NCT03675191) and have completed the three-month study
- Those who agreed the trial.
Who cannot join
- Those who have withdrawn the previous trial (NCT03675191)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance hospital
Yongin, Gyeonggi-do, 17046
Yu-Jin Kwon, Dr
About this study
Official title: An Observation Study on Maintaining Weight for 6 Months After 3 Months of Weight Loss Program
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]).
Read the 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.
- Conditions
- Weight Reduction
- Being tested
- observation of weight after 6months
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. .
| Study group | Role | What they receive |
|---|---|---|
| overweight or obese adults | overweight or obese adults who participate the trial (NCT03675191) Receives: Other: observation of weight after 6months |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight
weight changes
Measured: after 6months
Secondary outcomes (1)
lipid profile
total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride
Measured: after 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start17 Apr 2019
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Won Lee, Gangnam Severance Hospital
- Investigators
- Yu-Jin Kwon, Dr, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149756
- Sponsor's protocol ID
- YI201905
- Status last verified
- Oct 2019
- First submitted
- 31 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observation Study on Maintaining Weight for 6 Months After 3 Months of Weight Loss Program
- ClinicalTrials.gov ID
- NCT04149756
- Acronym / sponsor ID
- YI201905
- Conditions
- Weight Reduction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 17 Apr 2019 (actual)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| overweight or obese adults | – | Other: observation of weight after 6monthsoverweight or obese adults who participate the trial (NCT03675191) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Body mass index (BMI) more than 27kg/m2 with comorbidities or BMI more than 30kg/m2
Key inclusion criteria (2 listed)
- Those who have participated in the previous trial (NCT03675191) and have completed the three-month study
- Those who agreed the trial.
Key exclusion criteria (1 listed)
- Those who have withdrawn the previous trial (NCT03675191)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observation of weight after 6monthsThis 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. . | Other | overweight or obese adults |
Primary outcome
weight
Time frame: after 6months
weight changes
1 secondary outcome
lipid profile
Time frame: after 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Jin Kwon, Dr principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Reduction, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji-Won Lee, PhD (02-2019-3480, indi5645@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight (time frame: after 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.