Personalized Lifestyle Intervention and Weight Control

NCT ID: NCT04079972

Last Updated: 2026-01-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-11

Study Completion Date

2020-11-02

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

This was an open-label randomized controlled trial; no masking was implemented for participants, investigators, or outcome assessors.

Study Groups

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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.

Group Type EXPERIMENTAL

Obesity-related genetic information disclosure with tailored lifestyle recommendations

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Non-obesity-related genetic information disclosure

Intervention Type 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.

Interventions

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Obesity-related genetic information disclosure with tailored lifestyle recommendations

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

Intervention Type BEHAVIORAL

Non-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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NaNa Keum

OTHER

Sponsor Role lead

National Research Foundation of Korea

OTHER

Sponsor Role collaborator

DongGuk University

OTHER

Sponsor Role collaborator

Responsible Party

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NaNa Keum

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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NaNa Keum, ScD

Role: PRINCIPAL_INVESTIGATOR

DongGuk University

Locations

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Dongguk University

Goyang-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-12-006

Identifier Type: -

Identifier Source: org_study_id

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