RecruitingNot ApplicableNCT06117241

Reducing Metabolic Dysregulation in Dyads

A Transdisciplinary Approach to Investigating Metabolic and Risk of Early-Onset Colorectal Cancer: A Randomized Intervention Trial in Human Dyads and Mechanistic Study in Animals


Sponsor

University of South Carolina

Enrollment

180 participants

Start Date

Oct 17, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a 6-month randomized controlled trail of diet modification designed to reduce chronic inflammation and reverse metabolic dysfunction among obese individuals with one or more polyps found at a colonoscopy screening. We also will recruit an at least overweight partner, who lives in the same household. To be eligible, participants will be apparently disease-free, obese AAs or EAs who have self-identified a partner who is at least 9 years, with whom they live and who also is at least overweight. Each index participant will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have undergone a colonoscopy screening and found to have ≥1 polyp(s); 4) Be free of co-morbid conditions or other factors that would limit participation in this trial; 5) Have a BMI ≥30kg/m2; 6) Be willing to commit to investing the time and effort required to participate in this trial (i.e., willing to complete all assessments and provide biological samples as specified in the consent); and 7) Have no recent antibiotic use. Their partner needs to: 1) Be at least 9 years old; 2) Live in the same household and consumes meals together; 3) Be at least overweight; 4) Agree to all study procedures, including provision of biological samples, body measurements, and self-reported dietary and other assessments; and 5) Have no recent antibiotic use.


Eligibility

Min Age: 9 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests a lifestyle intervention aimed at reducing metabolic dysfunction (problems with how the body processes energy, sugar, and fat) in pairs of people — one adult who is at elevated risk for colorectal cancer and an overweight child or partner they live with. The idea is that changing behaviors together as a household is more effective than going it alone. **You may be eligible if:** - You are an African American or European American adult aged 55 or younger - You have a BMI of 30 or higher (obese) - You had a colonoscopy and were found to have at least one polyp that raises future colorectal cancer risk - You live with a partner or child who is at least 9 years old and overweight - Both you and your partner/child are free of major health conditions that would limit participation **You may NOT be eligible if:** - You don't have a cohabitating overweight partner or child - You have major health conditions that prevent participation in this lifestyle program - You are not willing to commit to the program requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALIMAGINE HEALTHY

An anti-inflammatory nutrition program including cooking classes, physical activity, and stress reduction.


Locations(1)

University of South Carolina

Columbia, South Carolina, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06117241


Related Trials