- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04079972
Personalized Lifestyle Intervention and Weight Control
December 13, 2025 updated by: NaNa Keum
Personalized Lifestyle Intervention Based on SNP Testing and Weight Control
This trial aims to investigate whether tailored lifestyle consultation through SNP testing leads to more effective weight loss among overweight or obese individuals compared to general lifestyle guidance for weight control.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gyeonggi-do
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Goyang-si, Gyeonggi-do, South Korea, 10326
- Dongguk University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Korean adults aged 18 years and older who are interested in weight management through dietary and/or exercise therapy.
- Individuals who are able and willing to participate consistently for the entire 2-year study period.
Exclusion Criteria:
- Individuals with any illness requiring regular medical treatment in a hospital.
- Individuals currently taking long-term prescribed medications.
- Individuals diagnosed with eating disorders or mental illnesses (e.g., depression, panic disorder) by a physician.
- Individuals who have undergone gastric surgery for weight loss.
- Individuals who have undergone heart surgery or cancer surgery.
- Individuals with severe anemia.
- Individuals who are unable to engage in physical exercise.
- Pregnant or breastfeeding women, or those planning to become pregnant within 2 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Disclosure of obesity-related genetic risk with tailored lifestyle recommendations
Participants received their obesity-related genetic test results, including variants in FTO (rs9939609), MC4R (rs17782313), and BDNF (rs6265), along with genotype-tailored lifestyle recommendations.
The counseling materials encouraged risk-allele carriers to adopt healthier behaviors such as reducing fat intake, limiting snacking, and avoiding emotional eating.
Personalized genetic results and recommendations were delivered at baseline through a user-friendly report.
|
They received their complete SNP results, including obesity-related traits, along with corresponding lifestyle recommendations.
|
|
Active Comparator: Disclosure of non-obesity-related genetic traits only
Participants received genetic test results limited to non-obesity-related traits (e.g., beauty-related genes).
They did not receive any obesity- or metabolism-related genetic information or tailored lifestyle recommendations.
The full obesity-related genetic results were disclosed only after completion of the final follow-up.
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Provided only with genetic test results related to beauty traits at baseline; information on metabolic health-related SNPs was disclosed only after the final follow-up assessment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Weight (kg)
Time Frame: About 5 months after randomization and at study completion (~17 months)
|
Change was calculated as the value at the later time point minus the value at baseline (i.e., value at about 5 months after randomization minus baseline, and value at study completion (~17 months) minus baseline).
Positive values represent increases from baseline, and negative values represent decreases.
|
About 5 months after randomization and at study completion (~17 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Fat Mass (kg)
Time Frame: About 5 months after randomization and at study completion (~17 months)
|
Change was calculated as the value at the later time point minus the value at baseline (i.e., value at about 5 months after randomization minus baseline, and value at study completion (~17 months) minus baseline).
Positive values represent increases from baseline, and negative values represent decreases.
|
About 5 months after randomization and at study completion (~17 months)
|
|
Body Fat Percentage (%)
Time Frame: About 5 months after randomization and at study completion (~17 months)
|
Change was calculated as the value at the later time point minus the value at baseline (i.e., value at about 5 months after randomization minus baseline, and value at study completion (~17 months) minus baseline).
Positive values represent increases from baseline, and negative values represent decreases.
|
About 5 months after randomization and at study completion (~17 months)
|
|
Skeletal Muscle Mass (kg)
Time Frame: About 5 months after randomization and at study completion (~17 months)
|
Change was calculated as the value at the later time point minus the value at baseline (i.e., value at about 5 months after randomization minus baseline, and value at study completion (~17 months) minus baseline).
Positive values represent increases from baseline, and negative values represent decreases.
|
About 5 months after randomization and at study completion (~17 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body composition (% muscle)
Time Frame: at six months, 1 year, and 2 years after randomization
|
change in body composition from the time of randomization
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at six months, 1 year, and 2 years after randomization
|
|
body composition (% fat)
Time Frame: at six months, 1 year, and 2 years after randomization
|
change in body composition from the time of randomization
|
at six months, 1 year, and 2 years after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: NaNa Keum, ScD, Dongguk University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2019
Primary Completion (Actual)
November 2, 2020
Study Completion (Actual)
November 2, 2020
Study Registration Dates
First Submitted
February 18, 2019
First Submitted That Met QC Criteria
September 3, 2019
First Posted (Actual)
September 6, 2019
Study Record Updates
Last Update Posted (Estimated)
January 6, 2026
Last Update Submitted That Met QC Criteria
December 13, 2025
Last Verified
October 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-12-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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