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Behavioural Intervention

Time-Restricted Eating + Mindfulness-Based Stress Reduction to Reduce Colorectal Cancer Risk (MBSR&TRE Trial)

N/A

Recruiting

Led By Manoela Lima Oliveira, MS, RD, LDN

Research Sponsored by Lisa Tussing-Humphreys

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-39 years old.

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 of the intervention; through study completion, an average of 9 weeks

Awards & highlights

MBSR&TRE Trial Summary

This trial aims to find out if a combination of remote TRE and MBSR interventions are feasible and can help reduce excess adiposity and moderate-to-severe perceived stress in young adults.

Who is the study for?

This trial is for young adults aged 18-39 with obesity (BMI between 30 and 49.99) who experience moderate-to-severe stress, as indicated by a score of ≥14 on the Perceived Stress Score. Participants must own and use a device with internet access.Check my eligibility

What is being tested?

The study tests if remote interventions like time-restricted eating (TRE) and mindfulness-based stress reduction (MBSR), alone or combined, are feasible for reducing early-onset colorectal cancer risks. It looks at weight loss, stress levels, body composition changes, cardiometabolic health, and microbiome alterations over an 8-week period.See study design

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects may include hunger or discomfort from TRE schedules and emotional discomfort during MBSR practices due to confronting stressful thoughts.

MBSR&TRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 39 years old.

MBSR&TRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 of the intervention; through study completion, an average of 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 of the intervention; through study completion, an average of 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 of the intervention; through study completion, an average of 9 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the study

Feasibility of the study

Secondary outcome measures

Body bone density

Body fat mass

Body lean mass

+9 more

MBSR&TRE Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: TRE aloneExperimental Treatment1 Intervention

Participants will be instructed to eat ad libitum from noon - 8:00pm daily and fast from 8:00pm - noon (16-h fast) for 8 weeks. During the 8-h eating window, there will be no restrictions on types or quantities of foods consumed. Participants will meet with a registered dietitian (RD) for 30 minutes at the start of the intervention to review instructions and goals and weekly thereafter. Adherence to the TRE intervention will be assessed as the number of adherent days per week.

Group II: TRE + MBSRExperimental Treatment2 Interventions

This group will follow a combined protocol of the TRE and MBSR interventions as described above.

Group III: MBSR aloneExperimental Treatment1 Intervention

Participants in this study will be granted access to a remote mindfulness-based stress reductions (MBSR) protocol. Participants will have access to the MBSR course, consisting of 30 audio lessons, each ranging from 9 to 14 minutes long. During the study, participants will be asked to complete four lessons per week during weeks 1-7 and two lessons during week 8.

Group IV: ControlActive Control1 Intervention

The control group will not receive any of the interventions previously described. To maintain a relationship with each participant in the control group, we will contact them once a week via text message to engage them to finalize the intervention period. At the end of the intervention period and after all data is collected, the RD will meet with the participant for 30 minutes and will educate them regarding the TRE protocol and provide access to the MBSR web-based program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MBSR

2016

Completed Phase 3

~1940

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Illinois at ChicagoOTHER

609 Previous Clinical Trials

1,559,261 Total Patients Enrolled

33 Trials studying Obesity

9,775 Patients Enrolled for Obesity

Lisa Tussing-HumphreysLead Sponsor

1 Previous Clinical Trials

133 Total Patients Enrolled

Manoela Lima Oliveira, MS, RD, LDNPrincipal InvestigatorPhD Candidate

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many volunteers have participated in this investigative research?

"Affirmative. Clinicaltrials.gov supports the fact that this trial, which was created on October 18th 2023, is recruiting patients at present. 48 individuals need to be recruited from one medical centre for participation in the study."

Answered by AI

Is eligibility for this medical trial limited to individuals over a certain age?

"This trial specifically requests that prospective candidates are between 18 and 39 years old. Conversely, there are 425 clinical trials for minors and 2421 studies dedicated to seniors aged 65 or older."

Answered by AI

Could I possibly qualify to join this clinical research?

"This clinical trial has space for 48 patients who are between 18 and 39 years old, have a BMI of 30-49.99 kg/m2., score ≥ 14 on the Perceived Stress Score (PSS) at screening, and own and use an Internet connected device such as a smartphone or tablet."

Answered by AI

Is there remaining availability for potential participants in this trial?

"Compiling the data from clinicaltrials.gov, this medical trial is presently accepting participants. It was first posted on October 18th 2023 and recently updated November 27th of that same year."

Answered by AI

What results are being sought from this research endeavor?

"The primary objective of this research trial, lasting an average of 9 weeks from baseline to completion, is to determine the acceptability of the study. Secondary endpoints include body fat mass (measured via DEXA scan), lean muscle mass (DEXA scan) and hair cortisol levels (as a marker for stress)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Lisa Tussing-Humphreys 2023. "Time-Restricted Eating and Mindfulness-Based Stress Reduction to Reduce the Risk of Early-Onset Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06022887.

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