Heal-Me Personalized Online Nutrition and Exercise Routines
PiONEeR
Heal-Me PiONEeR (Personalized Online Nutrition and Exercise Routines) - Reconnecting Vulnerable Outpatients With Multidisciplinary Care - a Randomized Controlled Trial Assessing 3 Levels of Online Programming in the Time of COVID
1 other identifier
interventional
216
1 country
1
Brief Summary
The purpose of this study is to compare 12-weeks of virtual multidisciplinary programming provided at three levels of support intensity to determine impacts on clinical outcomes, acceptability, and cost amongst outpatients with cancer, liver disease, or lung disease. Participants will be randomized to one of three groups: (i) standard care, (ii) a personnel-light app-based intervention, (iii) a personnel-intensive app-based intervention. Participants randomized to standard care will receive exercise and nutrition resources as well as a Garmin watch. Participants in the experimental groups will receive standard care, plus a 12-week multidisciplinary app-based personalized program involving 12 weeks of exercise programming and 10-weeks of nutrition programming. Participants in study group 3 will receive additional one-on-one care. The Research Ethics Board at the University of Alberta has approved this study. The protocol will measure patient-related outcome measures including physical function, quality of life, social isolation, and anxiety, as well as measures of acceptability and cost. 216 participants will take part in this study (n=72 per arm). Analyses: fitness testing and patient-reported outcomes will be administered before and after the intervention. Fitness and patient-reported outcomes will be compared using linear mixed models with random effects. App acceptability will be compared between groups using Chi-Square.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2020
CompletedStudy Start
First participant enrolled
November 30, 2020
CompletedFirst Posted
Study publicly available on registry
December 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2022
CompletedOctober 4, 2022
July 1, 2022
1 year
November 30, 2020
October 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lower Extremity Functional Scale (LEFS)
The difference in the pre- vs post-intervention change in LEFS score between groups (score range: 0-80, higher scores indicate higher function)
12 Weeks
Secondary Outcomes (10)
Upper Extremity Functional Index (UEFI)
12 weeks
Timed Sit-to-Stand (60 & 30 seconds)
12 Weeks
Timed One-Legged Stance
12 Weeks
2-Minute Step Test (2MST)
12 Weeks
Sit-and-Reach
12 Weeks
- +5 more secondary outcomes
Other Outcomes (7)
Physical activity
12 Weeks
Sedentary Time (International Sedentary Assessment Tool - ISAT)
12 Weeks
Protein Intake
12 Weeks
- +4 more other outcomes
Study Arms (3)
Standard Care
NO INTERVENTIONThe standard of care response to COVID. Educational materials will be provided to patients via email. The package will include a combination of personalized exercises, and nutrition information for healthy eating. Participants will also receive a Garmin watch to track their activity over the intervention.
App-Based, Personnel-Light Care
EXPERIMENTALAn app-based, "personnel-light" approach to virtual care with a focus on support through group-based interactions with the Trainers, Dietitians and other participants. The patient's personalized 12-week home based exercise program will be enabled in the app after a baseline exercise specialist appointment. The 10-week nutrition program will be enabled at week 3 after a virtual dietitian assessment in week 2 (\~1 hour). The home programs will auto-progress. Participants will also receive a Garmin watch to track their activity over the intervention.
App-Based, Personnel-Intensive Care
EXPERIMENTALAn app-based, "personnel-intensive" approach to virtual care with support through a combination of group-based interactions with Trainers, Dietitians and other participants, as well as one-on-one support with Exercise Trainers and Dietitians. In addition to Group 2 features, patient interaction with Trainers will be via live group classes AND 1-to-1 sessions: up to seven 1-to-1 consultations with an exercise specialist and three 1-to-1 consultations with a dietitian to review progress and goals and make any necessary modifications to programming. Participants will also receive a Garmin watch to track their activity over the intervention.
Interventions
App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking.
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- In one of the following 3 disease groups:
- Cancer survivor who has completed treatment or is receiving maintenance therapy
- Patient who is currently post-transplantation from liver or lung transplantation
- Patient with chronic lung disease who may or may not be listed for organ transplantation
- Previous enrolment in exercise rehabilitation program (i.e. rehabilitation "graduate")
- Access to an Internet connected device with video and audio capabilities
You may not qualify if:
- Compassionate care
- Unsafe to participate in a virtual exercise program
- Unable to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Alberta Innovates Health Solutionscollaborator
Study Sites (1)
University of Alberta
Edmonton, Alberta, T6G 2G4, Canada
Related Publications (3)
Tandon P, Ismond KP, Purdy G, Cruz C, Etruw E, Suderman K, Hyde A, Stickland M, Spence JC, Lien DC, Bhanji R, Prado CM, Miguel-Cruz A, Joy AA, Yaskina M, McNeely ML. Acceptability and Effectiveness of a Fully Web-Based Nutrition and Exercise Program for Individuals With Chronic Disease During COVID-19: Randomized Controlled Trial. J Med Internet Res. 2025 Mar 24;27:e57537. doi: 10.2196/57537.
PMID: 40126542DERIVEDTandon P, Purdy G, Ismond KP, Cruz C, Etruw E, Suderman K, Hyde A, Stickland M, Spence JC, Lien DC, Bhanji R, Prado CM, Cruz AM, Joy AA, Yaskina M, Round J, Harback K, Padwal R, McNeely ML. 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.
PMID: 35569753DERIVEDCruz C, Prado CM, Punja S, Tandon P. Use of digital technologies in the nutritional management of catabolism-prone chronic diseases: A rapid review. Clin Nutr ESPEN. 2021 Dec;46:152-166. doi: 10.1016/j.clnesp.2021.10.020. Epub 2021 Nov 1.
PMID: 34857190DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2020
First Posted
December 14, 2020
Study Start
November 30, 2020
Primary Completion
December 17, 2021
Study Completion
August 31, 2022
Last Updated
October 4, 2022
Record last verified: 2022-07