Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease

Puneeta Tandon; Graeme Purdy; Kathleen P Ismond; Christofer Cruz; Evelyn Etruw; Kirsten Suderman; Ashley Hyde; Michael Stickland; John C Spence; Dale C Lien; Rahima Bhanji; Carla M Prado; Antonio Miguel Cruz; Anil A Joy; Maryna Yaskina; Jeff Round; Kate Harback; Raj Padwal; Margaret L McNeely

doi:10.1016/j.cct.2022.106791

Heal-me PiONEer (personalized online nutrition and exercise): An RCT assessing 2 levels of app-based programming in individuals with chronic disease

Contemp Clin Trials. 2022 Jul:118:106791. doi: 10.1016/j.cct.2022.106791. Epub 2022 May 13.

Authors

Puneeta Tandon¹, Graeme Purdy², Kathleen P Ismond³, Christofer Cruz³, Evelyn Etruw⁴, Kirsten Suderman², Ashley Hyde³, Michael Stickland⁵, John C Spence⁶, Dale C Lien⁵, Rahima Bhanji³, Carla M Prado⁷, Antonio Miguel Cruz⁸, Anil A Joy⁹, Maryna Yaskina¹⁰, Jeff Round¹¹, Kate Harback¹¹, Raj Padwal¹², Margaret L McNeely¹³

Affiliations

¹ Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada. Electronic address: ptandon@ualberta.ca.
² Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada.
³ Department of Medicine, Division of Gastroenterology, University of Alberta, Edmonton, AB, Canada.
⁴ Department of Medicine, Division of Pulmonary Medicine, University of Alberta, Edmonton, AB, Canada; Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, AB, Canada.
⁵ Department of Medicine, Division of Pulmonary Medicine, University of Alberta, Edmonton, AB, Canada.
⁶ Faculty of Kinesiology, Sport, and Recreation, University of Alberta, Edmonton, AB, Canada.
⁷ Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, AB, Canada.
⁸ Department of Occupational Therapy, Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, AB, Canada.
⁹ Department of Oncology, Division of Medical Oncology, University of Alberta and Cross Cancer Institute, Edmonton, AB, Canada.
¹⁰ Women's and Children's Health Research Institute, Statistics, University of Alberta, Edmonton, AB, Canada.
¹¹ Institute of Health Economics, Edmonton, AB, Canada.
¹² Department of Medicine, Division of General Internal Medicine, University of Alberta, Edmonton, AB, Canada.
¹³ Department of Physical Therapy, University of Alberta, Edmonton, AB, Canada; Department of Oncology, Cancer Care Alberta, Edmonton, AB, Canada. Electronic address: mmcneely@ualberta.ca.

PMID: 35569753
DOI: 10.1016/j.cct.2022.106791

Abstract

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.

Trial registration: ClinicalTrials.gov NCT04666558.

Keywords: Adherence; Cancer; Chronic lung disease; Online; Post-transplant; Virtual.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Chronic Disease
Exercise
Exercise Therapy
Humans
Mobile Applications*
Quality of Life*

Associated data

ClinicalTrials.gov/NCT04666558