Lifestyle Changes for Weight Management

(ORF Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Augusta University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 in Georgia, USA who are overweight or have obesity. Participants must have a BMI between 25.0 and 40 Kg/m2 or higher. It's not open to those outside the specified BMI range.

Inclusion Criteria

My BMI is between 30.0 and 34.9, classifying me as having lower-risk obesity.
I am between 18 and 70 years old.
My BMI is between 25.0 and 29.9, so I am overweight but not obese.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Genotyping and Participant Stratification

Genetic variation of the MC4R gene is assessed and participants are stratified into genotype-based intervention groups

2 weeks

Genotype-Informed Lifestyle Intervention

Participants undergo an 8-week personalized dietary and physical activity intervention based on their genotype

8 weeks
4 visits (in-person)

Follow-up

Participants are monitored for changes in body composition, dietary patterns, and physical activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Diet and exercise
  • Exercise
  • Lifestyle Intervention

Trial Overview

The study investigates how genetics (specifically MC4R polymorphisms) and lifestyle factors like diet and exercise affect weight management in people with different levels of obesity.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ScreeningExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Augusta University

Lead Sponsor

Trials
219
Recruited
85,900+