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Physical Activity Intervention for Obesity-Related Cancer Risk

N/A

Recruiting

Led By Genevieve F Dunton, PhD MPH

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first full day of intervention (i.e., day 8) to last day of data collection (i.e., day 21)

Awards & highlights

Study Summary

This trial tests a novel physical activity intervention to see if it's effective and accepted by adults at risk for cancer due to weight.

Who is the study for?

The eMOTION Study is for adults in the U.S. who are overweight or obese (BMI of 25+), lead a sedentary lifestyle (less than 60 minutes of structured physical activity per week), and are at increased risk for cancer. Participants must be over 18, own a smartphone with Internet access, speak English, and be willing to wear and read a Fitbit Versa smartwatch provided by the study.Check my eligibility

What is being tested?

This phase 1 trial tests the acceptability and feasibility of new physical activity interventions aimed at reducing cancer risk due to obesity. Interventions include SAVOR Enhancement, Affect-Based Goals, TYPE/CONTEXT Enhancement, and Intensity-Based Goals.See study design

What are the potential side effects?

As this is an exercise intervention study focused on increasing physical activity through behavioral changes using technology like Fitbits, side effects may include typical exercise-related issues such as muscle soreness or strain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first day of run-in period (i.e., day 1) to last day of data collection (i.e., day 21) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Accessibility/Usability Benchmark: System Usability Scale score (0 to 100) for Daily Goal Sessions & Fitbit

Efficacy Benchmark: Percentage of participants with increased physical activity enjoyment

Equity Benchmark: Accessibility (SUS score) approximately equal between sub-groups

+1 more

Secondary outcome measures

Accessibility Benchmark: Participants report being able to understand and follow savoring prompts (affect-based goals + SAVOR group only)

Accessibility Benchmark: Percentage of participants rating Fitbit interface as accessible

Accessibility Benchmark: Percentage of participants rating smartphone interface as accessible

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: IntensityExperimental Treatment1 Intervention

Participants receive intensity-based goals for two weeks. No enhancements are added to the standard mHealth intervention.

Group II: AffectExperimental Treatment1 Intervention

Participants receive affect-based goals for two weeks. No enhancements are added to the standard mHealth intervention.

Group III: Affect + TYPE/CONTEXTActive Control2 Interventions

Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the TYPE/CONTEXT enhancement to augment the treatment effects of the affect-based goals condition.

Group IV: Affect + SAVORActive Control2 Interventions

Participants receive affect-based goals for two weeks. In addition to the standard mHealth intervention, participants engage in the SAVOR enhancement to augment the treatment effects of the affect-based goals condition.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,658 Previous Clinical Trials

40,924,453 Total Patients Enrolled

5 Trials studying Sedentary Lifestyle

173 Patients Enrolled for Sedentary Lifestyle

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,242 Total Patients Enrolled

4 Trials studying Sedentary Lifestyle

190 Patients Enrolled for Sedentary Lifestyle

Genevieve F Dunton, PhD MPHPrincipal InvestigatorUniversity of Southern California

Frequently Asked Questions

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

Are there still opportunities for participants to join this clinical experiment?

"The information displayed on the clinicaltrials.gov website indicates that this trial is currently looking for volunteers, with recruitment beginning on October 6th 2023 and being most recently updated on November 7th of the same year."

Answered by AI

How many participants have been enrolled in this research project?

"Yes, according to clinicaltrials.gov the trial is still open for enrollment. This medical study was first posted on October 6th 2023 and most recently updated on November 7th 2023; it aims to recruit 36 volunteers from a single site."

Answered by AI

What are the objectives of this clinical investigation?

"The primary aim of this trial, which will be assessed after 3 weeks, is to determine the percentage of participants who experience an adverse event. Secondary objectives involve evaluating the sustainability/feasibility (with a go/no-go criterion that fewer than 25% need to have their Fitbit device mailed due to malfunctions during tracking) and accessibility (via participant surveys asking whether they were able to read instructions for their smartphone interface or watch face surveys on the Fitbit - with at least 51% responding affirmatively required for both questions)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

eMOTION Formative Study

Genevieve Dunton 2023. "eMOTION Formative Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06125964.