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Behavioral Intervention
Diet Change for Metabolic Dysfunction in Colorectal Polyp Patients (REMEDY Trial)
N/A
Recruiting
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≤55 years old
Agreed to undergo colonoscopy screening and found to have ≥1 polyp(s) that place them at elevated risk for future adenomas and CRC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3-month, 6-month
Awards & highlights
REMEDY Trial Summary
This trial will test whether a diet change can reduce chronic inflammation and reverse metabolic dysfunction in obese people with polyps. A partner who is at least overweight is also required. Eligibility includes being ≤55, BMI ≥30kg/m2 and no recent antibiotic use.
Who is the study for?
This trial is for disease-free, obese African Americans or European Americans under 55 years old with at least one polyp found during colonoscopy. They must have a BMI of ≥30kg/m2 and a partner who is at least overweight and shares meals with them. Both should not have used antibiotics recently.Check my eligibility
What is being tested?
The 'IMAGINE HEALTHY' program focuses on diet modification to reduce inflammation and reverse metabolic dysfunction in obese individuals with colorectal polyps and their overweight partners over a period of six months.See study design
What are the potential side effects?
Since this study involves dietary changes rather than medication, side effects may include gastrointestinal discomfort due to new foods or eating patterns but are generally expected to be minimal.
REMEDY Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 55 years old or younger.
Select...
I have polyps found during a colonoscopy that increase my risk for future cancer.
REMEDY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3-month, 6-month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3-month, 6-month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood
Stool
REMEDY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Participation will be for six months. Participants will meet staff at three timepoints (baseline, 3 months, 6 months) to complete questionnaires, online dietary assessment, body measures, have blood pressure measured, provide blood and stool samples, and wear an activity monitor for a week at each time point. In addition, participants will attend weekly classes for 12 weeks and one class per month for three months. These classes will include cooking, movement, and stress reduction.
Group II: ComparisonActive Control1 Intervention
Participation will be for six months. Participants will meet staff at three timepoints (baseline, 3 months, 6 months) to complete questionnaires, online dietary assessment, body measures, have blood pressure measured, provide blood and stool samples, and wear an activity monitor for a week at each time point.
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Who is running the clinical trial?
University of South CarolinaLead Sponsor
213 Previous Clinical Trials
121,076 Total Patients Enrolled
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