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Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer

NCT06022887 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-08-21

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

TRE

daily ad libitum food intake, 8-h 12pm - 8pm, 8 wks active weight loss phase;

BEHAVIORAL

MBSR

Completed 30 sessions of a Mindfulness-Based Stress Reduction (MBSR) interventions for 8 weeks

Sponsors & Collaborators

  • University of Illinois at Chicago

    collaborator OTHER

  • Lisa Tussing-Humphreys

    lead OTHER

Principal Investigators

  • Manoela Lima Oliveira, MS, RD, LDN · PhD Candidate

  • Lisa M Tussing-Humphreys, PHD, RD · Associate Professor, Kinesiology and Nutrition

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2024-07-24
Completion
2024-07-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06022887 on ClinicalTrials.gov