Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Feb 20, 2024
Date Accepted: Jan 21, 2025
Acceptability and effectiveness of a fully virtually delivered and evaluated web-based nutrition and exercise program for individuals with chronic disease: a randomized controlled trial during COVID-19
ABSTRACT
Background:
In-person nutrition and exercise interventions improve physical function in chronic diseases. We report a semi-supervised nutrition and exercise program using a fully online process from recruitment through to end of trial measures in response to COVID-19.
Objective:
Primary study objectives were acceptability and effectiveness.
Methods:
Using a 3-arm randomized controlled trial design, we evaluated a 12-week program delivered across two levels of support as a web-based intervention (“Heal-Me”). Eligible adults (cancer, chronic lung disease, or transplant recipients) required access to an internet-connected device and had all previously completed exercise rehabilitation. Participants were randomized (1:1:1) to Arm 1 (self-directed online nutrition and exercise guide), Arm 2 (Heal-Me + dietitian/exercise specialist-led online group classes), or Arm 3 (Heal-Me + online group classes + one-to-one sessions). All received a wearable activity tracker. Primary study objectives were acceptability and effectiveness. The acceptability outcomes were adherence rate and satisfaction. The primary effectiveness outcome was change in the self-reported Lower Extremity Functional Scale (LEFS) with secondary outcomes including physical function tests, and questionnaires for wellbeing, quality of life, and food intake. Analyses adhered to intention-to-treat.
Results:
202 of 216 (94%) participants completed the intervention (mean: 61 ± 11 years; female: 64.4%; cancer: 62.4%; lung disease: 20.8%; lung transplant: 8.9%; liver transplant: 7.9%). Adherence exceeded a priori targets: 82% attended >75% of the program elements including post-intervention tests; and >80% reported moderate to high satisfaction. No significant differences were found for LEFS scores. Significant benefits were found in favor of Heal-Me supported programming for the change in 2-minute step test, WHO-5 well-being, scale SF-36 physical health and energy/fatigue scales, and target protein intake parameters. No serious adverse events occurred.
Conclusions:
The demonstrated satisfaction, adherence, and effectiveness highlight the feasibility of a web-based semi-supervised nutrition and exercise intervention studied entirely online in individuals with chronic disease. The more intensive one-to-one interaction (Arm 3) led to greater improvements in perceived nutrition self-management. Clinical Trial: NCT04666558
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