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临床试验/NCT07341841
NCT07341841Enrolling By Invitation不适用

Assessing Obesity Related Risk Factors in Burke, Columbia, Richmond (BCR) Adult Population: A Genetic and Behavioral Study

Augusta University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
100
试验地点
1
主要终点
Diet and exercise

研究概览

简要总结

This study aims to explore the association between Melanocortin-4 Receptor (MC4R) polymorphisms, eating habits, and social determinants of health in a heterogeneous adult population in Georgia, USA.

详细描述

The study has three aims.

Aim 1: Genotyping and Participant Stratification To assess the genetic variation of the MC4R gene in the Burke-Columbia-Richmond (BCR) population using Targeted DNA sequencing technology and stratify participants into genotype-based intervention groups (e.g., risk vs. non-risk variants). We anticipate seeing differences in MC4R gene polymorphisms within the BCR residents.

Aim 2: Genotype-Informed Lifestyle Intervention To evaluate the effects of an 8-week personalized dietary and physical activity intervention and association with the frequency distribution of the MC4R variants in the BCR using modified Diet History Questionnaire II (DHQ II) and bicycle ergometer, respectively. In addition, the association between body composition and the subject's age group will be measured using BOD POD instrument. We expect to find associations between food intake and the MC4R variants within the residents of the BCR area. We also expect to see the difference between age groups and the MC4R variant based on body composition.

Primary outcome: change in body composition, primarily body fat percentage Secondary outcomes: changes in dietary patterns, physical activity, and BMI

Aim 3: Socioeconomic and environmental factors To assess whether socio-economic status and environmental inequalities influence diet quality and obesity status of the BCR residents. Data will be collected through a structured questionnaire and secondary sources, such as the U.S. Census Bureau. We expect to find differences in the obesity profiles in the BCR adult population due to socio-economic and environmental inequalities. We hypothesize that the MC4R variants, socio-economic, and environmental inequalities are correlated with eating habits and obesity status within BCR residents.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults 18-70 years old are included in the study.
  • Target populations are 4 groups:
  • Group 1 - overweight (not obese), if BMI is 25.0-29.9 Kg/m2;
  • Group 2 - Class 1 (lower-risk) obesity, if BMI is 30.0-34.9 Kg/m2;
  • Group 3 - Class 2 (moderate-risk) obesity, if BMI is 35-39.9 Kg/m2 and
  • Group 4 - Class 3 (high-risk) obesity, if BMI is equal or greater than 40 Kg/m
  • Males and females will participate in the study.

排除标准

  • Children younger than 18 years old and adults over 70 are excluded from the study. Non-English speakers and individuals with impaired decision-making capacity to consent are excluded from the study.

研究组 & 干预措施

Screening

Other

Diet and exercise baseline

干预措施: Diet and exercise (Behavioral)

Screening

Other

Diet and exercise baseline

干预措施: Lifestyle Intervention (Behavioral)

Screening

Other

Diet and exercise baseline

干预措施: Exercise (Behavioral)

结局指标

主要结局

Diet and exercise

时间窗: 8 weeks

Calorie intake, BMI, % fat, % lean mass.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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