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Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE
NCT06011499 · OHSU Knight Cancer Institute
In plain English
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Official title
Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE)
About this study
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.
Eligibility criteria
Inclusion Criteria:
* INTERVENTION PARTICIPANTS: Age 18 or older
* INTERVENTION PARTICIPANTS: Diagnosed with histologically confirmed prostate cancer
* INTERVENTION PARTICIPANTS: Received \>= 6 months of ADT any time in the past 10 years
* INTERVENTION PARTICIPANTS: Completed radiotherapy, chemotherapy and/or surgery \> 6 weeks prior to
* INTERVENTION PARTICIPANTS: No intent to start adjuvant chemotherapy or radiotherapy within 6 months of enrollment
* INTERVENTION PARTICIPANTS: Overweight or obese (body mass index \> 25 kg/m2 to BMI ≤ 50).
* INTERVENTION PARTICIPANTS: Evidence of frailty by meeting three or more of the following frailty criteria: weakness, slowness, fatigue, inactivity, and/or illness
* INTERVENTION PARTICIPANTS: Not currently engaging in structured diet or resistance strength training exercise program
* INTERVENTION PARTICIPANTS: Willing to be randomized into either study arm and adhere to study protocol
* INTERVENTION PARTICIPANTS: Home internet sufficient for videoconferencing
* INTERVENTION PARTICIPANTS: Signed informed consent
* IMPLEMENTATION PARTICIPANTS: Be a key stakeholder (i.e., healthcare provider or administrative, or intervention participant \[completers, partial completers, or no participation\])
* IMPLEMENTATION PARTICIPANTS: Verbal informed consent following receipt of an information sheet
Exclusion Criteria:
* INTERVENTION PARTICIPANTS: Unintentional weight loss \> 5% within the last year
* INTERVENTION PARTICIPANTS: Contraindication to moderate intensity exercise
* INTERVENTION PARTICIPANTS: Health or medical condition that affects weight status/body composition (e.g., Cushing's syndrome, uncontrolled hyper-/hypo- thyroidism)
* INTERVENTION PARTICIPANTS: Active malignancy (other than non-melanoma skin cancer)
* INTERVENTION PARTICIPANTS: Not fluent in English and therefore incapable of answer survey questions, following directions during exercise or performance testing, and providing informed consent in English
* INTERVENTION PARTICIPANTS: Currently taking or have taken creatine supplement in the month preceding baseline creatine testing
Study design
Enrollment target: 250 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-03-12
Estimated completion: 2027-12-31
Last updated: 2025-05-31
Interventions
Other: Internet-Based Exercise InterventionOther: Internet-Based Diet InterventionOther: Education Intervention
Primary outcomes
- • Change in overweight/obesity (At baseline, 3 months, 6 months and 12 months)
- • Change in sarcopenia (At baseline and 6 months)
- • Change in slowness (At baseline, 3 months and 6 months)
Sponsor
OHSU Knight Cancer Institute · other
With: National Cancer Institute (NCI), Oregon Health and Science University, University of Alabama at Birmingham
Contacts & investigators
ContactCarolyn Guidarelli, MPH · contact · borsch@ohsu.edu · 503-346-0307
ContactSharon McCoy, MS · contact · mccoys@ohsu.edu · 503-494-1676
InvestigatorKerri Winters-Stone · principal_investigator, OHSU Knight Cancer Institute
All locations (2)
University of AlabamaNot Yet Recruiting
Birmingham, Alabama, United States
OHSU Knight Cancer InstituteRecruiting
Portland, Oregon, United States