Weight Loss
Conditions
Brief 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.
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.
Sponsors
National Research Foundation of Korea
DongGuk University
NaNa Keum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This was an open-label randomized controlled trial; no masking was implemented for participants, investigators, or outcome assessors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight (kg) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Fat Mass (kg) | 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. |
| Body Fat Percentage (%) | 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. |
| Skeletal Muscle Mass (kg) | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| 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. | 26 |
| Total | 53 |
Baseline characteristics
| Characteristic | Active Comparator: Disclosure of Non-Obesity-related Genetic Traits Only | Total | Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle Recommendations |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 53 Participants | 27 Participants |
| Age, Continuous | 22.31 years STANDARD_DEVIATION 3.07 | 22.26 years STANDARD_DEVIATION 2.9 | 22.22 years STANDARD_DEVIATION 2.8 |
| Body fat mass (kg) | 23.1 kg STANDARD_DEVIATION 6.8 | 22.1 kg STANDARD_DEVIATION 8.4 | 21.1 kg STANDARD_DEVIATION 9.8 |
| Body fat percentage (%) | 31.1 percentage STANDARD_DEVIATION 7.7 | 29.2 percentage STANDARD_DEVIATION 9.3 | 28.3 percentage STANDARD_DEVIATION 10.7 |
| Body Weight (kg) | 76.8 kg STANDARD_DEVIATION 11.2 | 75.6 kg STANDARD_DEVIATION 11.6 | 74.3 kg STANDARD_DEVIATION 12.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 26 Participants | 53 Participants | 27 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 26 participants | 53 participants | 27 participants |
| Sex: Female, Male Female | 10 Participants | 21 Participants | 11 Participants |
| Sex: Female, Male Male | 16 Participants | 32 Participants | 16 Participants |
| Skeletal muscle mass (kg) | 30.1 kg STANDARD_DEVIATION 6 | 29.9 kg STANDARD_DEVIATION 6.3 | 29.8 kg STANDARD_DEVIATION 6.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 26 |
| other Total, other adverse events | 0 / 27 | 0 / 26 |
| serious Total, serious adverse events | 0 / 27 | 0 / 26 |
Outcome results
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.
Time frame: About 5 months after randomization and at study completion (~17 months)
Population: number of started population differs from completed population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Body Weight (kg) | About 5 months after randomization | 75.2 kg | Standard Deviation 13.2 |
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Body Weight (kg) | About 17 months after randomization | 80.3 kg | Standard Deviation 19.4 |
| Disclosure of non-obesity-related genetic traits only | Body Weight (kg) | About 5 months after randomization | 79.2 kg | Standard Deviation 10.5 |
| Disclosure of non-obesity-related genetic traits only | Body Weight (kg) | About 17 months after randomization | 74.5 kg | Standard Deviation 12.5 |
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.
Time frame: About 5 months after randomization and at study completion (~17 months)
Population: number of started population differs from completed population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Body Fat Mass (kg) | About 5 months after randomization | 21.4 kg | Standard Deviation 10.2 |
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Body Fat Mass (kg) | About 17 months after randomization | 25.9 kg | Standard Deviation 12.3 |
| Disclosure of non-obesity-related genetic traits only | Body Fat Mass (kg) | About 5 months after randomization | 23.7 kg | Standard Deviation 7 |
| Disclosure of non-obesity-related genetic traits only | Body Fat Mass (kg) | About 17 months after randomization | 23.8 kg | Standard Deviation 8 |
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.
Time frame: About 5 months after randomization and at study completion (~17 months)
Population: number of started population differs from completed population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Body Fat Percentage (%) | About 5 months after randomization | 28.5 percentage | Standard Deviation 10.5 |
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Body Fat Percentage (%) | About 17 months after randomization | 31.8 percentage | Standard Deviation 9 |
| Disclosure of non-obesity-related genetic traits only | Body Fat Percentage (%) | About 5 months after randomization | 29.8 percentage | Standard Deviation 7.8 |
| Disclosure of non-obesity-related genetic traits only | Body Fat Percentage (%) | About 17 months after randomization | 31.8 percentage | Standard Deviation 8.4 |
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.
Time frame: About 5 months after randomization and at study completion (~17 months)
Population: number of started population differs from completed population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Skeletal Muscle Mass (kg) | About 5 months after randomization | 30.1 kg | Standard Deviation 7.1 |
| Disclosure of obesity-related genetic risk with tailored lifestyle recommendations | Skeletal Muscle Mass (kg) | About 17 months after randomization | 30.4 kg | Standard Deviation 7.4 |
| Disclosure of non-obesity-related genetic traits only | Skeletal Muscle Mass (kg) | About 5 months after randomization | 31.1 kg | Standard Deviation 5.6 |
| Disclosure of non-obesity-related genetic traits only | Skeletal Muscle Mass (kg) | About 17 months after randomization | 28.1 kg | Standard Deviation 5.9 |