Assessing Obesity Related Risk Factors in Adult Population: A Genetic and Behavioral Study (ORF)

Augusta University

Status

Invitation-only

Conditions

Obesity Prevention

Treatments

Behavioral: Exercise

Behavioral: Lifestyle Intervention

Behavioral: Diet and exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07341841

SPH

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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/m2.

Males and females will participate in the study.

Exclusion criteria

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.