Weight LossNCT04079972

Personalized Lifestyle Intervention and Weight Control

A study testing Obesity-related genetic information disclosure with tailored lifestyle recommendations and Non-obesity-related genetic information disclosure in people with Weight Loss, run by NaNa Keum at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Weight Loss
What is being tested?: Obesity-related genetic information disclosure with tailored lifestyle recommendations and Non-obesity-related genetic information disclosure
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 1 siteSouth Korea
Study dates: 11 Jun 2019to 2 Nov 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Dongguk University
Goyang-si, Gyeonggi-do, 10326

Other trials in South Korea

About this study

Official title: Personalized Lifestyle Intervention Based on SNP Testing and Weight Control

Conditions: Weight Loss
Being tested: Obesity-related genetic information disclosure with tailored lifestyle recommendations, Non-obesity-related genetic information disclosure
Medical subject headings: Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Obesity-related genetic information disclosure with tailored lifestyle recommendationsBehavioural
They received their complete SNP results, including obesity-related traits, along with corresponding lifestyle recommendations.
Non-obesity-related genetic information disclosureBehavioural
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.

Study groups in NCT04079972
Study group	Role	What they receive
Disclosure of obesity-related genetic risk with tailored lifestyle recommendations	Experimental	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. Receives: Behavioral: Obesity-related genetic information disclosure with tailored lifestyle recommendations
Disclosure of non-obesity-related genetic traits only	Active comparator	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. Receives: Behavioral: Non-obesity-related genetic information disclosure

What is being measured

The primary outcome is the main question the study is designed to answer.

Body Weight (kg)
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.
Measured: About 5 months after randomization and at study completion (~17 months)

Secondary outcomes (3)

Body Fat Mass (kg)
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.
Measured: About 5 months after randomization and at study completion (~17 months)
Body Fat Percentage (%)
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.
Measured: About 5 months after randomization and at study completion (~17 months)
Skeletal Muscle Mass (kg)
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.
Measured: About 5 months after randomization and at study completion (~17 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 20192 Nov 2020

First posted6 Sep 2019
Study start11 Jun 2019
Primary completion2 Nov 2020
Study completion2 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Weight LossStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04079972
Sponsor's protocol ID: 2018-12-006
Status last verified: Oct 2025
First submitted: 18 Feb 2019
Last updated: 6 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Weight Loss trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized Lifestyle Intervention Based on SNP Testing and Weight Control
ClinicalTrials.gov ID: NCT04079972
Acronym / sponsor ID: 2018-12-006
Conditions: Weight Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: NaNa KeumUniversity, hospital or other
Collaborators: National Research Foundation of Korea, DongGuk University
Study start: 11 Jun 2019 (actual)
Primary completion: 2 Nov 2020 (actual)
Study completion: 2 Nov 2020 (actual)
First posted: 6 Sep 2019 (actual)
Results: Posted 6 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Disclosure of obesity-related genetic risk with tailored lifestyle recommendations	Experimental	Behavioral: Obesity-related genetic information disclosure with tailored lifestyle recommendationsParticipants 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.
Disclosure of non-obesity-related genetic traits only	Active comparator	Behavioral: Non-obesity-related genetic information disclosureParticipants 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.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (8 listed)

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.

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
Obesity-related genetic information disclosure with tailored lifestyle recommendationsThey received their complete SNP results, including obesity-related traits, along with corresponding lifestyle recommendations.	Behavioural	Disclosure of obesity-related genetic risk with tailored lifestyle recommendations
Non-obesity-related genetic information disclosureProvided 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.	Behavioural	Disclosure of non-obesity-related genetic traits only

Primary outcome

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.

3 secondary outcomes

Body Fat Mass (kg)
Time frame: 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)
Skeletal Muscle Mass (kg)
Time frame: About 5 months after randomization and at study completion (~17 months)

Results and safety

Results posted to the registry on 6 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle Recommendations	27	20
Active Comparator: Disclosure of Non-Obesity-related Genetic Traits Only	26	21

Primary outcome: Body Weight (kg)

Time frame: About 5 months after randomization and at study completion (~17 months). Mean (Standard Deviation). Unit: kg

Measure	Disclosure of obesity-related genetic risk with tailored lifestyle recommendations n = 27	Disclosure of non-obesity-related genetic traits only n = 26
About 5 months after randomization	75.2 (13.2)	79.2 (10.5)
About 17 months after randomization	80.3 (19.4)	74.5 (12.5)

Population analysed: number of started population differs from completed population

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse events were observed from enrollment through study completion (up to ~17 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle Recommendations	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Disclosure of Non-Obesity-related Genetic Traits Only	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Weight Loss

Not yet recruitingPhase 1/2
Tocilizumab Combined With First-Line Chemo-Immunotherapy in Metastatic Non-Small Cell Lung Cancer
Metastatic Non-Small Cell Lung Cancer, Cancer-Associated Weight Loss
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
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Not yet recruitingPhase 3
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
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Active, not recruitingPhase 2
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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.

NaNa Keum, ScD principal investigator

DongGuk University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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: finished, as of the sponsor's last update on 6 Jan 2026. 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?

Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body Weight (kg) (time frame: About 5 months after randomization and at study completion (~17 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04079972.

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 6 Jan 2026.