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Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)
This clinical trial tests the effectiveness of an online weight loss plus resistance training intervention (iLIVE) to decrease obesity and improve frailty in men with prostate cancer who received androgen deprivation therapy (ADT). Androgen deprivation therapy increases the risk of frailty, weight gain and obesity in prostate cancer survivors. The combination of frailty and obesity can lead to a decrease in quality of life and an increased risk of recurrent falls. Using iLIVE may improve obesity and frailty in men with prostate cancer who receive ADT.
PRIMARY OBJECTIVE: I. To test the effectiveness of a combined online weight loss plus resistance training intervention (iLIVE) on obese frailty in prostate cancer survivors (PCS) on ADT. SECONDARY OBJECTIVES: I. To understand the effect of iLIVE on health behaviors, physical functioning, and quality of life II. To understand facilitators and barriers to implementing iLIVE in clinical and community practice OUTLINE: Patients are randomized to arm I or II. Key stakeholders are identified for implementation outcomes ARM I: Patients receive online access to an interactive weight loss website and participate in online group based resistance training sessions (iLIVE) on study. Patients also use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study. ARM II: Patients receive usual care with access to online survivorship and exercise recommendations and use a Fitbit fitness tracker and Aria (registered trademark) smart scale while on study. Patients are followed for 6 months after completion of intervention. Key stakeholders complete an interview while on study to assess barriers and facilitators to implementation of iLIVE into clinical practice.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama
Birmingham, Alabama, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
Start Date
March 12, 2024
Primary Completion Date
September 30, 2027
Completion Date
December 31, 2027
Last Updated
May 31, 2025
250
ESTIMATED participants
Internet-Based Exercise Intervention
OTHER
Internet-Based Diet Intervention
OTHER
Education Intervention
OTHER
Lead Sponsor
OHSU Knight Cancer Institute
Collaborators
NCT04550494
NCT04857502
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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