Protocol for the internet-based lifestyle intervention to eradicate obese frailty in prostate cancer survivors (iLIVE) randomized controlled trial: a type I hybrid effectiveness implementation trial

Obese frailty is a growing national problem as trends towards aging and obesity converge. This problem is especially acute in men with prostate cancer treated with androgen deprivation therapy (ADT). ADT is the backbone of therapy for advanced prostate cancer, a disease which affects mostly older men. But, ADT accelerates muscle loss and gains in adiposity which threaten physical functioning and quality of life. Diet and resistance training may mitigate obese frailty but have rarely been combined in an accessible delivery format. The Internet-Based Lifestyle Intervention to Eradicate Obese Frailty in Prostate Cancer Survivors (iLIVE) Randomized Controlled Trial (RCT) aims to mitigate obese frailty among men with prostate cancer treated with ADT. Participants (N=250) are being recruited across North America to participate in this RCT that is implemented entirely over the internet. Eligibility criteria include body mass index >25 kg/m2 and > 2 frailty symptoms [illness, fatigue, inactivity, weakness, slowness]). Consented participants undergo assessments that include: online surveys (medical status, falls, physical activity, quality-of-life, healthcare utilization); dietary recalls (kilocalories, diet quality); body weight (Aria® scales); physical activity (Fitbits®); 4) internet-based physical performance (chair stand, timed up-and-go, gait speed tests); and 5) muscle mass (D3 creatine dilution). Participants are then randomized to one of two 6-month interventions: 1) Enhanced Usual Care (EUC): Encouraged to continue Aria® scale and Fitbit® use with monthly emails of publicly available diet- and exercise-related information; or 2) iLIVE: Same as EUC, plus website access to weekly serialized sessions on weight loss and diet quality and thrice-weekly live remote supervised group resistance training sessions. Assessments are repeated at 6-months; at 12-months, questionnaires are repeated and data from digital devices are captured. Intent-to-treat analysis will compare EUC vs. iLIVE (baseline-to-6-months) using a composite measure of obese frailty as the primary outcome. Designed as a type I hybrid-effectiveness implementation trial, data on intervention feasibility (including safety), acceptability, adoption, appropriateness, fidelity, sustainability, and cost are assessed, tracked, and analyzed. The iLIVE RCT is implemented exclusively over the internet and provides a blueprint for other highly scalable lifestyle interventions with potential for rapid translation into nationwide practice. ClinicalTrials.gov: NCT06011499 (5.31.2025: https://clinicaltrials.gov/study/NCT06011499).