Personalized Lifestyle Intervention and Weight Control

NCT04079972 | Completed Results

• 1 other identifier: 2018-12-006
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss

Outcome Measures

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.

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

Secondary Outcomes (3)

• Body Fat Mass (kg)

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

• Body Fat Percentage (%)

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

• Skeletal Muscle Mass (kg)

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

Study Arms (2)

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.

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.

Behavioral: Non-obesity-related genetic information disclosure

Interventions

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.

Disclosure of non-obesity-related genetic traits only

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.

Disclosure of obesity-related genetic risk with tailored lifestyle recommendations

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NaNa Keum: lead
• National Research Foundation of Korea: collaborator
• DongGuk University: collaborator

Study Sites (1)

Dongguk University

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr.NaNa Keum
• Organization: Dongguk University

nak212@mail.harvard.edu

+82 10-6793-6654

Study Officials

• NaNa Keum, ScD

  DongGuk University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label randomized controlled trial; no masking was implemented for participants, investigators, or outcome assessors.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: September 6, 2019
• Study Start: June 11, 2019
• Primary Completion: November 2, 2020
• Study Completion: November 2, 2020
• Last Updated: January 6, 2026
• Results First Posted: October 6, 2025

Record last verified: 2025-10

Locations

KR (1)