NCT07341841

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Obesity Prevention

Interventions

Type	Name	Description
BEHAVIORAL	Diet and exercise	Diet intervention: Participants will be randomly divided into a control group (n=50) and a training group (n=50) using the simplest method of assigning participants to different treatment groups: a coin toss. They will be surveyed using the modified DHII questionnaire to assess their caloric intake. The baseline calorie intake will be evaluated during the first visit. Participants will be instructed to reduce their portion sizes by half of what they typically consume. The commitment of participants will be for 8 weeks. Exercise intervention: In the first visit, subjects will be familiarized with exercise on a bicycle ergometer to eliminate the novel effects of a new experience. The subjects in the training group will then come to our laboratory to participate in an 8-week exercise program; the control group will not undergo training during this experimental period. The training group will train on a bicycle ergometer for 30 minutes, 3 days a week, for 8 weeks.
BEHAVIORAL	Lifestyle Intervention	8-week personalized diet using a personalized low-calorie diet based on the caloric intake baseline using modified Diet History Questionnaire II (DHQ II)
BEHAVIORAL	Exercise	8-week personalized physical activity- subjects will be doing 30-minute exercise three times a week using a bicycle ergometer

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2026-01-14
• Last updated: 2026-01-14

Locations

1 site across 1 country: United States