Reducing Metabolic Dysregulation in Dyads

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT06117241
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
9 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • IMAGINE HEALTHY — BEHAVIORAL
    An anti-inflammatory nutrition program including cooking classes, physical activity, and stress reduction.

Study Details

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.

Key Dates

Start date
Oct 17, 2023
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: Comparison
    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.
  • Experimental: 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.

Primary Outcome Measure

Blood [ Time Frame: Baseline, 3-month, 6-month ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of South CarolinaColumbiaSouth Carolina29208
James R Hebert, ScD
[email protected]
803-576-5613
Gauri Sathe
[email protected]
803-576-5613

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