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

NCT ID: NCT07341841

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-12-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening

Diet and exercise baseline

Group Type: OTHER

Diet and exercise

Intervention Type: BEHAVIORAL

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.

Lifestyle Intervention

Intervention Type: BEHAVIORAL

8-week personalized diet using a personalized low-calorie diet based on the caloric intake baseline using modified Diet History Questionnaire II (DHQ II)

Exercise

Intervention Type: BEHAVIORAL

8-week personalized physical activity- subjects will be doing 30-minute exercise three times a week using a bicycle ergometer

Interventions

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.

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Exercise

8-week personalized physical activity- subjects will be doing 30-minute exercise three times a week using a bicycle ergometer

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Augusta University

Augusta, Georgia, United States

Countries

United States

Other Identifiers

SPH

Identifier Type: -

Identifier Source: org_study_id