Trial Outcomes & Findings for Personalized Lifestyle Intervention and Weight Control (NCT NCT04079972)
NCT ID: NCT04079972
Last Updated: 2026-01-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
About 5 months after randomization and at study completion (~17 months)
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
About 5 months after randomization
STARTED
|
27
|
26
|
|
About 5 months after randomization
COMPLETED
|
20
|
21
|
|
About 5 months after randomization
NOT COMPLETED
|
7
|
5
|
|
About 17 months after randomization
STARTED
|
20
|
21
|
|
About 17 months after randomization
COMPLETED
|
8
|
10
|
|
About 17 months after randomization
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Personalized Lifestyle Intervention and Weight Control
Baseline characteristics by cohort
| Measure |
Experimental: Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle Recommendations
n=27 Participants
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.
|
Active Comparator: Disclosure of Non-Obesity-related Genetic Traits Only
n=26 Participants
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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=37 Participants
|
26 Participants
n=56 Participants
|
53 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Age, Continuous
|
22.22 years
STANDARD_DEVIATION 2.80 • n=37 Participants
|
22.31 years
STANDARD_DEVIATION 3.07 • n=56 Participants
|
22.26 years
STANDARD_DEVIATION 2.90 • n=82 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=37 Participants
|
10 Participants
n=56 Participants
|
21 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=37 Participants
|
16 Participants
n=56 Participants
|
32 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=37 Participants
|
26 Participants
n=56 Participants
|
53 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Region of Enrollment
South Korea
|
27 participants
n=37 Participants
|
26 participants
n=56 Participants
|
53 participants
n=82 Participants
|
|
Body Weight (kg)
|
74.3 kg
STANDARD_DEVIATION 12.1 • n=37 Participants
|
76.8 kg
STANDARD_DEVIATION 11.2 • n=56 Participants
|
75.6 kg
STANDARD_DEVIATION 11.6 • n=82 Participants
|
|
Body fat mass (kg)
|
21.1 kg
STANDARD_DEVIATION 9.8 • n=37 Participants
|
23.1 kg
STANDARD_DEVIATION 6.8 • n=56 Participants
|
22.1 kg
STANDARD_DEVIATION 8.4 • n=82 Participants
|
|
Body fat percentage (%)
|
28.3 percentage
STANDARD_DEVIATION 10.7 • n=37 Participants
|
31.1 percentage
STANDARD_DEVIATION 7.7 • n=56 Participants
|
29.2 percentage
STANDARD_DEVIATION 9.3 • n=82 Participants
|
|
Skeletal muscle mass (kg)
|
29.8 kg
STANDARD_DEVIATION 6.8 • n=37 Participants
|
30.1 kg
STANDARD_DEVIATION 6.0 • n=56 Participants
|
29.9 kg
STANDARD_DEVIATION 6.3 • n=82 Participants
|
PRIMARY outcome
Timeframe: About 5 months after randomization and at study completion (~17 months)Population: number of started population differs from completed population
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.
Outcome measures
| Measure |
Disclosure of obesity-related genetic risk with tailored lifestyle recommendations
n=27 Participants
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.
|
Disclosure of non-obesity-related genetic traits only
n=26 Participants
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.
|
|---|---|---|
|
Body Weight (kg)
About 5 months after randomization
|
75.2 kg
Standard Deviation 13.2
|
79.2 kg
Standard Deviation 10.5
|
|
Body Weight (kg)
About 17 months after randomization
|
80.3 kg
Standard Deviation 19.4
|
74.5 kg
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: About 5 months after randomization and at study completion (~17 months)Population: number of started population differs from completed population
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.
Outcome measures
| Measure |
Disclosure of obesity-related genetic risk with tailored lifestyle recommendations
n=27 Participants
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.
|
Disclosure of non-obesity-related genetic traits only
n=26 Participants
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.
|
|---|---|---|
|
Body Fat Mass (kg)
About 5 months after randomization
|
21.4 kg
Standard Deviation 10.2
|
23.7 kg
Standard Deviation 7.0
|
|
Body Fat Mass (kg)
About 17 months after randomization
|
25.9 kg
Standard Deviation 12.3
|
23.8 kg
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: About 5 months after randomization and at study completion (~17 months)Population: number of started population differs from completed population
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.
Outcome measures
| Measure |
Disclosure of obesity-related genetic risk with tailored lifestyle recommendations
n=27 Participants
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.
|
Disclosure of non-obesity-related genetic traits only
n=26 Participants
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.
|
|---|---|---|
|
Body Fat Percentage (%)
About 5 months after randomization
|
28.5 percentage
Standard Deviation 10.5
|
29.8 percentage
Standard Deviation 7.8
|
|
Body Fat Percentage (%)
About 17 months after randomization
|
31.8 percentage
Standard Deviation 9.0
|
31.8 percentage
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: About 5 months after randomization and at study completion (~17 months)Population: number of started population differs from completed population
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.
Outcome measures
| Measure |
Disclosure of obesity-related genetic risk with tailored lifestyle recommendations
n=27 Participants
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.
|
Disclosure of non-obesity-related genetic traits only
n=26 Participants
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.
|
|---|---|---|
|
Skeletal Muscle Mass (kg)
About 5 months after randomization
|
30.1 kg
Standard Deviation 7.1
|
31.1 kg
Standard Deviation 5.6
|
|
Skeletal Muscle Mass (kg)
About 17 months after randomization
|
30.4 kg
Standard Deviation 7.4
|
28.1 kg
Standard Deviation 5.9
|
Adverse Events
Disclosure of Obesity-related Genetic Risk With Tailored Lifestyle Recommendations
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Disclosure of Non-Obesity-related Genetic Traits Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place