Online Lifestyle Intervention (iLIVE) for Prostate Cancer Survivors

This study, called iLIVE, is testing an online program for men with prostate cancer who have received androgen deprivation therapy (ADT). ADT can lead to weight gain, obesity, and frailty (weakness and decreased physical function). The iLIVE program includes online supervised group resistance training and an interactive website with diet and weight loss information. Researchers want to see if iLIVE can reduce obesity and improve frailty in these survivors. The study aims to enroll 250 participants and is currently unclear regarding its recruitment status. Success will be measured by changes in overweight/obesity, sarcopenia (muscle loss), and slowness over 3, 6, and 12 months.

Study design
This interventional study will randomize participants to either the iLIVE online program or usual care with educational information. It aims to enroll 250 participants.
What's involved
Participants will either engage in online resistance training and use a diet website, or receive educational materials. All participants will use a Fitbit and smart scale.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after completing the intervention.

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NCT06011499

Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors, iLIVE

Recruiting
NAAges 18+InterventionalSupportive care
OHSU Knight Cancer Institute
~250 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Internet-Based Exercise InterventionInternet-Based Diet InterventionEducation Intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in overweight/obesity
Measured over At baseline, 3 months, 6 months and 12 months
+5 more outcomes measured
Prostate Carcinoma
1 sites across 1 states
Oregon1
  • Kerri Winters-Stone, PhD · PRINCIPAL_INVESTIGATOR · OHSU Knight Cancer Institute
  • Wendy Demark-Wahnefried, PhD, RD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

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Eligibility criteria

Inclusion

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

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
  • Change in overweight/obesityAt baseline, 3 months, 6 months and 12 months

    Measured from weight assessed on the Aria (registered trademark) scale at the time of the online assessment and self-reported height. Overweight is defined as body mass index \> 25 kg/m\^2 and a 5% loss will be viewed as a successful outcome.

  • Change in sarcopeniaAt baseline and 6 months

    Measured by 30 mg D3 creatine (D3Cr) capsule which they will ingest and then urinate on a test strip on the second void upon waking 3-6 days later. The enrichment of D3Cr will be measured from the test strip along with urine creatine and creatinine. Will use a cutoff of \< 10.75 kg/m\^2 (moderate sarcopenia).

  • Change in slownessAt baseline, 3 months and 6 months

    Measured by the fastest time of two 4m walks at a usual pace administered by study staff by remote teleconference. Will use a cut point for "slowness" in older men of speed \< 1.0 m/s - a clinically meaningful cutoff that predicts falls and loss of independence.

  • Change in weaknessAt baseline, 3 months, and 6 months

    Measured by the seconds required to rise from a chair five times, administered by study staff by remote teleconference. Chair stand time \> 12 seconds predicts a 2.4 increased risk of falls in older adults and we will apply this cutoff for "weakness."

  • Change in inactivityAt baseline, 3 months, 6 months, and 12 months

    Measured by physical activity-related energy expenditure, calculated from self-report on the 41-item Community Health Activities Model Program for Seniors (CHAMPS) physical activity questionnaire. We will use \< 383 kcals per week spent in moderate-vigorous intensity activity as our low activity cut point. Measured also by Fitbit.

  • Change in fatigueAt baseline, 3 months, 6 months, and 12 months

    Measured using the 4-item short form (SF)-36 Vitality Scale. Will use cut points of scores of \< 50.00 (normed) for prostate cancer survivors (PCS) aged 50-64 years or scores less than 40.00 (normed) for PCS aged 65+ years.