CClinicalTrials.gg
CompletedNCT04079972Updated Jan 6, 2026Results posted

Personalized Lifestyle Intervention and Weight Control

An interventional study of Obesity-related genetic information disclosure with tailored lifestyle recommendations and Non-obesity-related genetic information disclosure in Weight Loss, sponsored by NaNa Keum. Completed at 1 site in South Korea. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by NaNa Keum · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Weight Loss

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03

In context

Weight Loss

1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.

This study's enrollment of 53 is below the median of 73 across 1,496 interventional studies indexed under Weight Loss.

Browse Weight Loss studies →

Lead sponsor

This is the only study on the registry with NaNa Keum as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Korean adults aged 18 years and older who are interested in weight management through dietary and/or exercise therapy.
  2. Individuals who are able and willing to participate consistently for the entire 2-year study period.

Exclusion criteria

Exclusion Criteria:

  1. Individuals with any illness requiring regular medical treatment in a hospital.
  2. Individuals currently taking long-term prescribed medications.
  3. Individuals diagnosed with eating disorders or mental illnesses (e.g., depression, panic disorder) by a physician.
  4. Individuals who have undergone gastric surgery for weight loss.
  5. Individuals who have undergone heart surgery or cancer surgery.
  6. Individuals with severe anemia.
  7. Individuals who are unable to engage in physical exercise.
  8. Pregnant or breastfeeding women, or those planning to become pregnant within 2 years.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • 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.

    Behavioral: Obesity-related genetic information disclosure with tailored 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.

    Behavioral: Non-obesity-related genetic information disclosure

Interventions

  • BehavioralObesity-related genetic information disclosure with tailored lifestyle recommendations

    They received their complete SNP results, including obesity-related traits, along with corresponding lifestyle recommendations.

  • BehavioralNon-obesity-related genetic information disclosure

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: About 5 months after randomization and at study completion (~17 months)

Secondary outcomes

  1. 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.

    Time frame: About 5 months after randomization and at study completion (~17 months)

  2. 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.

    Time frame: About 5 months after randomization and at study completion (~17 months)

  3. 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.

    Time frame: About 5 months after randomization and at study completion (~17 months)

07

Results

Posted Oct 6, 2025

Participant flow

About 5 months after randomization
Participant flow — About 5 months after randomization
MilestoneExperimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits Only
Started2726
Completed2021
Not completed75
About 17 months after randomization
Participant flow — About 17 months after randomization
MilestoneExperimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits Only
Started2021
Completed810
Not completed1211

Outcome measures

PrimaryBody 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.

Time frame:
About 5 months after randomization and at study completion (~17 months)
Reported as:
Mean · kg
Body Weight (kg)
kgDisclosure of obesity-related genetic risk with tailored lifestyle recommendationsDisclosure of non-obesity-related genetic traits only
About 5 months after randomization75.2 ± 13.279.2 ± 10.5
About 17 months after randomization80.3 ± 19.474.5 ± 12.5
SecondaryBody 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.

Time frame:
About 5 months after randomization and at study completion (~17 months)
Reported as:
Mean · kg
Body Fat Mass (kg)
kgDisclosure of obesity-related genetic risk with tailored lifestyle recommendationsDisclosure of non-obesity-related genetic traits only
About 5 months after randomization21.4 ± 10.223.7 ± 7.0
About 17 months after randomization25.9 ± 12.323.8 ± 8.0
SecondaryBody 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.

Time frame:
About 5 months after randomization and at study completion (~17 months)
Reported as:
Mean · percentage
Body Fat Percentage (%)
percentageDisclosure of obesity-related genetic risk with tailored lifestyle recommendationsDisclosure of non-obesity-related genetic traits only
About 5 months after randomization28.5 ± 10.529.8 ± 7.8
About 17 months after randomization31.8 ± 9.031.8 ± 8.4
SecondarySkeletal 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.

Time frame:
About 5 months after randomization and at study completion (~17 months)
Reported as:
Mean · kg
Skeletal Muscle Mass (kg)
kgDisclosure of obesity-related genetic risk with tailored lifestyle recommendationsDisclosure of non-obesity-related genetic traits only
About 5 months after randomization30.1 ± 7.131.1 ± 5.6
About 17 months after randomization30.4 ± 7.428.1 ± 5.9

Adverse events

Collected over No adverse events were observed from enrollment through study completion (up to ~17 months).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle Recommendations0/27 (0%)0/27 (0%)0/27 (0%)
Disclosure of Non-Obesity-related Genetic Traits Only0/26 (0%)0/26 (0%)0/26 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
<=18 years000
Between 18 and 65 years272653
>=65 years000
Age, Continuous
Age, Continuous(years)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
Mean22.22 ± 2.8022.31 ± 3.0722.26 ± 2.90
Sex: Female, Male
Sex: Female, Male(Participants)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
Female111021
Male161632
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
American Indian or Alaska Native000
Asian272653
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
South Korea272653
Body Weight (kg)
Body Weight (kg)(kg)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
Mean74.3 ± 12.176.8 ± 11.275.6 ± 11.6
Body fat mass (kg)
Body fat mass (kg)(kg)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
Mean21.1 ± 9.823.1 ± 6.822.1 ± 8.4
Body fat percentage (%)
Body fat percentage (%)(percentage)Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle RecommendationsActive Comparator: Disclosure of Non-Obesity-related Genetic Traits OnlyTotal
Mean28.3 ± 10.731.1 ± 7.729.2 ± 9.3

1 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Dongguk University
    Goyang-si, Gyeonggi-do 10326, South Korea
09

References and documents

Study documents

  • Study protocol · Dec 6, 2018
  • Statistical analysis plan · Jun 6, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04079972
Lead sponsor
NaNa Keum
Collaborators
National Research Foundation of Korea, DongGuk University
Responsible party
NaNa Keum (Associate Professor, DongGuk University) — Sponsor-investigator
First posted
Sep 6, 2019
Start date
Jun 11, 2019
Primary completion
Nov 2, 2020
Completion
Nov 2, 2020
Results posted
Oct 6, 2025
Last update
Jan 6, 2026

Study contacts

NaNa Keum, ScD
principal investigator · DongGuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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