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| Name | Class |
|---|---|
| National Research Foundation of Korea | OTHER |
| DongGuk University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obesity-related genetic information disclosure with tailored lifestyle recommendations | Behavioral | They received their complete SNP results, including obesity-related traits, along with corresponding lifestyle recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | About 5 months after randomization and at study completion (~17 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | About 5 months after randomization and at study completion (~17 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| NaNa Keum, ScD | DongGuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguk University | Goyang-si | Gyeonggi-do | 10326 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| About 5 months after randomization |
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| About 17 months after randomization |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | number of started population differs from completed population | Posted | Mean | Standard Deviation | kg | About 5 months after randomization and at study completion (~17 months) |
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No adverse events were observed from enrollment through study completion (up to ~17 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.NaNa Keum | Dongguk University | +82 10-6793-6654 | nak212@mail.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 6, 2018 | Dec 13, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 6, 2018 | Dec 13, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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This was an open-label randomized controlled trial; no masking was implemented for participants, investigators, or outcome assessors.
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| Non-obesity-related genetic information disclosure | Behavioral | 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. |
|
| 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. | 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. | About 5 months after randomization and at study completion (~17 months) |
| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Weight (kg) | Mean | Standard Deviation | kg |
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| Body fat mass (kg) | Mean | Standard Deviation | kg |
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| Body fat percentage (%) | Mean | Standard Deviation | percentage |
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| Skeletal muscle mass (kg) | Mean | Standard Deviation | kg |
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| OG001 | 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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| Secondary | 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. | number of started population differs from completed population | Posted | Mean | Standard Deviation | kg | About 5 months after randomization and at study completion (~17 months) |
|
|
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| Secondary | 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. | number of started population differs from completed population | Posted | Mean | Standard Deviation | percentage | About 5 months after randomization and at study completion (~17 months) |
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|
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| Secondary | 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. | number of started population differs from completed population | Posted | Mean | Standard Deviation | kg | About 5 months after randomization and at study completion (~17 months) |
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 26 | 0 | 26 | 0 | 26 |
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| About 17 months after randomization |
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| About 17 months after randomization |
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| About 17 months after randomization |
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