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

NCT07341841 | Enrolling By Invitation

• 1 other identifier: SPH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity Prevention

Keywords

MC4R, gene variant. obesity, diet

Outcome Measures

Primary Outcomes (1)

• Diet and exercise

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

  8 weeks

Study Arms (1)

Screening

OTHER

Diet and exercise baseline

Behavioral: Diet and exercise; Behavioral: Lifestyle Intervention; Behavioral: Exercise

Interventions

Diet and exercise 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.

Screening

Lifestyle Intervention 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)

Screening

Exercise BEHAVIORAL

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

Screening

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Interventions

Diet; Exercise

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: January 14, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)