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

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]).

Study Overview

• Status: Unknown
• Conditions: Weight Reduction
• Intervention / Treatment: Other: observation of weight after 6months

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Ji-Won Lee, PhD; Phone Number: 02-2019-3480; Email: indi5645@yuhs.ac
• Study Contact Backup: Name: Yu-Jin Kwon, Dr; Phone Number: 031-331-8710; Email: digda3@yuhs.ac

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, Korea, Republic of, 17046
      • Recruiting
      • Yongin Severance Hospital
      • Contact: Yu-Jin Kwon, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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• Those who have withdrawn the previous trial (NCT03675191)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
overweight or obese adults; overweight or obese adults who participate the trial (NCT03675191)	Other: observation of weight after 6months; 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. .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	weight changes	after 6months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital
• Investigators: Principal Investigator: Yu-Jin Kwon, Dr, Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2019
• Primary Completion (Anticipated): October 30, 2019
• Study Completion (Anticipated): November 30, 2019

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): November 4, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: YI201905

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No