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临床试验/NCT04079972
NCT04079972已完成不适用

Personalized Lifestyle Intervention Based on SNP Testing and Weight Control

NaNa Keum1 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2019年6月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
NaNa Keum
入组人数
53
试验地点
1
主要终点
Body Weight (kg)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None (Outcomes Assessor)

盲法说明

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Obesity-related genetic information disclosure with tailored lifestyle recommendations (Behavioral)

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.

干预措施: Non-obesity-related genetic information disclosure (Behavioral)

结局指标

主要结局

Body Weight (kg)

时间窗: 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.

次要结局

  • 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))

研究者

发起方
NaNa Keum
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

NaNa Keum

Associate Professor

DongGuk University

研究点 (1)

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