NCT06022887Completed
Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer
Feasibility and Acceptability of a Remote Time-Restricted Eating and Mindfulness-Based Stress Reduction Intervention to Reduce Risk Factors Associated With Early-Onset Colorectal Cancer Development Among Young Adults
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the feasibility of remote time-restricted eating (TRE) and mindfulness-based stress reduction (MBSR) interventions and the preliminary effect on EOCRC-related markers. The main question\[s\] it aims to answer are: * Is it feasible and acceptable to conduct 8-week remote interventions of TRE, MBSR, and combined TRE+MBSR among young adults with excess adiposity and moderate-to-severe perceived stress? * Will participants in the combined group lose more body weight and reduce their stress levels than those in the remaining groups? * Will participants in the combined group experience better body composition changes and improve their cardiometabolic health compared to those in the remaining groups? * Will participants in the combined group exhibit changes in the microbiome compared to those in the remaining groups? Participants will: * Complete 8 weeks of a TRE intervention * Complete 8 weeks of a remote MBSR intervention Researchers will compare 1. TRE alone; 2. MBSR alone; 3. TRE + MBSR; and 4. Control to see if the study is feasible and acceptable; to see if individuals lose body weight; to see if individual stress levels reduce; to see changes in the microbiome.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 23 Aug 2023
- Start date
- 18 Oct 2023
- Primary completion date
- 24 Jul 2024
- Lead sponsor
- Lisa Tussing-Humphreys
- Diseases
- Obesity, Colorectal cancer
- NCT number
- NCT06022887
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 18 Oct 2023 to the primary completion date, 24 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have taken antibiotics in the previous 2 months.
- Currently taking corticosteroids medication - inhaled, topical, or oral in the past 2 months (affects cortisol measures).
- Are on a weight-loss diet or involved in a formal weight-loss program or are not weight stable for 3 months (+/- 4.5 kg) prior to the study.
- Have schizophrenia (medication can affect study outcomes).
- Currently taking weight loss medication.
- Illegal drug use in the past month (not marijuana).
Other illness
- Have a personal or family history of EOCRC.
- Have an inflammatory bowel disease or genetic predisposition to EOCRC or CRC (e.g., Lynch syndrome);.
- Any cancer diagnosis or cancer treatment in the past 12 months.
- Have history of bariatric surgery or bowel resection.
- Have an active infection.
- Have type 1 or type 2 diabetes, immunodeficiency/autoimmune disorder, or inflammatory bowel disease.
- Present a history of eating disorder.
Other
- Consume \>50 grams ethanol daily (approximately 4-5, 12 ounces beers).
- Use combustible tobacco.
- Use fiber or pre-/probiotic supplements \>3 days per week.
- Females who are pregnant/trying to become pregnant.
- Have an eating window of \<10 hours/day or are currently following an intermittent fasting pattern.
- Night shift workers (shift passes midnight).
Who the study is looking for
- 18-39 years old.
- BMI 30-49.99 kg/m2.
- Own and use a smartphone, computer, or tablet with access to the Internet.
- Score ≥ 14 on the Perceived Stress Score (PSS) at screening.
Age in the registry: 18 years to 39 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Applied Health Sciences Building - University of Illinois at Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.