Evaluating the Impact of a Virtually Supervised Exercise Intervention and Group Counseling on Inflammation and the Microbiome of Smokers at High Risk for Lung Cancer, BE FIT Trial

February 11, 2026 updated by: Marisa Bittoni, Ohio State University Comprehensive Cancer Center

The BE FIT Study: Feasibility of an Exercise Intervention on Microbiome and Immune Function in a High-Risk Cohort for Lung Cancer

This phase II trial evaluates how a virtually supervised exercise intervention in combination with group counseling affects inflammation and the bacterial composition (microbiome) of the gut in smokers who are at high risk for lung cancer. Physical exercise has been shown to reduce lung cancer development and to have beneficial effects on the gut microbiome and inflammation. Group counseling may promote adherence to the exercise intervention by empowering participants to exert greater control over their behavior and environment. This clinical trial may help researchers understand how exercise impacts inflammation and the microbiome in people at risk for lung cancer and whether or not exercise with counseling can improve health outcomes in high-risk individuals.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC).

II. To determine the impact of the multi-component virtually-delivered exercise intervention on the microbiome and inflammatory biomarkers.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth twice a week (BIW) in weeks 1-8 and once a week (QW) in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.

GROUP II: Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.

After completion of study intervention, participants are followed up at 12 weeks and 1 year.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 50-77 years of age
  • Current or former smoker with 20-pack year smoking history and within the last 15 years
  • Fewer than 150 minutes of participation in moderate intensity physical activity each week
  • All participants must be free of severe heart, respiratory (e.g. chronic obstructive pulmonary disease [COPD]), or systemic disease that would make moderate intensity exercise participation unsafe
  • Willing to sign an informed consent

Exclusion Criteria:

  • Person undergoing treatment for cancer in any form
  • Person plans to enter smoking cessation or change status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (exercise intervention)
Participants receive the supervised aerobic and resistance exercise intervention over 1 hour via telehealth BIW in weeks 1-8 and QW in weeks 9-12 and then continue with unsupervised exercise sessions BIW in weeks 13-52. Participants also attend group counseling sessions over 1 hour QW in weeks 1-8 and bi-weekly in weeks 9-12. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Other: Medical Device Usage and Evaluation
Wear Fitbit
Other: Exercise Counseling
Attend group counseling
Other: Exercise Intervention
Receive aerobic and resistance exercise intervention via telehealth
Other: Telemedicine
Receive aerobic and resistance exercise intervention via telehealth
Other Names:
  • Telehealth
Active Comparator: Group II (usual care)
Participants receive usual care consisting of education on standard recommendations for physical activity, the benefits of exercise, and an example of a light walking program. Participants also wear a Fitbit throughout the trial and undergo collection of blood samples at baseline and follow up.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive usual care
Other Names:
  • standard of care
  • standard therapy
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Physical Performance Testing
Ancillary studies
Other Names:
  • Physical Fitness Testing
  • Physical Function Testing
Other: Medical Device Usage and Evaluation
Wear Fitbit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients recruited to virtually-delivered exercise intervention (feasibility)
Time Frame: Up to 1 year
To evaluate the feasibility and preliminary efficacy of establishing a multi-component virtually-delivered exercise intervention trial with longitudinal biomarker and microbiome collection in the Ohio State University Lung Cancer Screening Clinic (OSULCSC)
Up to 1 year
Proportion of patients who achieve study adherence (feasibility) based on attendance to the exercise program sessions and biospecimens submitted.
Time Frame: During 12-week program
Study adherence is defined as a) the proportion of patients attending at least 20 out of 24 sessions for the 12-week program and b) the percentage of biospecimen samples collected at the post program period (12 weeks). This study will be considered feasible if the compliance rate for both of these combined is 75% or more. Descriptive statistics will be used to examine the distribution of all patient and treatment characteristics, including compliance.
During 12-week program
Assess the number of participants with a change in inflammatory biomarkers
Time Frame: Baseline to post-intervention (12 weeks)
Will assess the effect of the intervention on inflammatory markers of C-reactive protein and IL-6 separately using linear mixed models with the biomarker serving as the outcome variable. Will also assess the changes in the biomarkers across time in each intervention group.
Baseline to post-intervention (12 weeks)
Microbe relative abundances
Time Frame: Baseline to post-intervention (12 weeks)
Will assess the effect of the intervention on the diversity and relative abundances of individual microbes. Will compare everyone's post-intervention time point to baseline in control and the exercise interventions cohorts, applying linear or generalized mixed-effects models for the diversity or individual microbes.
Baseline to post-intervention (12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University Comprehensive Cancer Center

Investigators

  • Principal Investigator: Marisa Bittoni, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSU-22194
  • NCI-2023-05556 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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