Background App-based strategies are a promising solution to deliver nutrition and exercise interventions during social distancing. With limited RCT data in individuals with chronic disease, further information is required both to determine impact, and to guide delivery. The Heal-Me app is an evidence-based, theoretically informed nutrition and exercise solution that can be tailored for use across a range of individuals with chronic disease. As compared to controls receiving educational material, the aim of this study is to assess the acceptability, effectiveness, and cost of Heal-Me app programming delivered alongside two levels of dietitian and exercise-specialist support. Methods Heal-Me PiONEer is a 12-week, 3-arm RCT with randomization to one of three study groups (n=72 per group, 216 total). Group 1 (control: educational material), Group 2 (Heal-Me app + virtual group dietitian/exercise-specialist sessions), Group 3 (Heal-Me app + virtual group and 1-to-1 dietitian/exercise-specialist sessions). Inclusion criteria: adults with cancer, chronic lung disease or status post-transplantation from liver or lung transplant; previous completion of an exercise rehabilitation program; access to an internet-connected device. Study outcomes measured at study weeks 0 and 12 include: Primary - Lower Extremity Functional Scale; Secondary – virtual physical function tests, loneliness, resilience, anxiety, well-being and health-related quality of life; Exploratory outcomes – protein intake, behavioral beliefs around exercise and nutrition, adherence, adverse events, acceptability, and cost-utility. Conclusions The Heal-Me PiONEer RCT holds promise to provide a comprehensive understanding of the delivery and impact of app-based nutrition and exercise programming in a diverse group of participants with chronic disease.
Background: In-person nutrition and exercise interventions improve physical function in chronic diseases, yet the acceptability and effectiveness of web-based delivery, especially with different levels of personnel support, require further investigation. Objective: This study aims to evaluate a web-based nutrition and exercise intervention delivered entirely digitally from recruitment to trial completion. Methods: A randomized controlled trial was conducted using the Heal-Me version 1 platform across 2 levels of personnel support (Light and Intensive). Eligible adults with a history of cancer, chronic lung disease, or liver or lung transplant; internet access; and prior participation in a rehabilitation program were enrolled in a fully web-based program to minimize barriers to exercise participation. Participants were randomly assigned (1:1:1) to 1 of 3 study groups. The control group received a detailed, self-directed digital nutrition and exercise guide. The Heal-Me Light group received the web-based intervention alongside dietitian and exercise specialist–led group classes. The Heal-Me Intensive group received web-based intervention, group classes, and one-to-one sessions with the dietitians and exercise specialists. All participants received a wearable activity tracker. The primary acceptability outcome was adherence to the intervention based on a priori targets. The primary effectiveness outcome was the change in Lower Extremity Functional Scale (LEFS) score. Secondary outcomes included physical function tests, which were performed and measured by videoconference. Questionnaires were used to assess well-being, quality of life, and food intake. Analyses adhered to the intention-to-treat principle. Results: Of 216 participants, 202 (93.5%) completed the intervention (mean 61, SD 11 years; female: 130/202, 64.4%; cancer: 126/202, 62.4%). Adherence exceeded a priori targets, with 82% (105/128) attending >75% of the program elements including postintervention tests. Participants rated the program as “quite a bit” or “very” useful, with similar ratings between Heal-Me Light (56/64, 88%) and Heal-Me Intensive (51/58, 88%) groups (P=.69). No significant differences were found for changes in LEFS scores (control: mean 0.8, SD 7.7; Heal-Me: mean 0.3, SD 6.6; P=.53). Significant benefits were found in favor of the combined Heal-Me intervention groups versus controls for change in the 2-minute step test, World Health Organization-5 Well-Being Index, Short-Form-36 general, physical health role, energy or fatigue scales, and protein intake. While the change in physical function was similar between the 2 intervention arms, the more intensive one-to-one interaction (Heal-Me Intensive) led to greater improvements in perceived nutrition self-management. No serious adverse events occurred. Conclusions: The demonstrated satisfaction, adherence, and effectiveness highlight the high acceptability of a web-based, semisupervised nutrition and exercise intervention delivered entirely digitally in individuals with chronic disease. Future studies may benefit from having a baseline physical function inclusion threshold, the use of a more sensitive primary physical function measure, and a higher intensity digital exercise intervention in exercise-experienced participants. Trial Registration: Clinicaltrials.gov NCT04666558; https://clinicaltrials.gov/study/NCT04666558