Utilizing Technology for Diet and Exercise Change in Complex Chronic Conditions Across Diverse Environments (U-DECIDE): Protocol for a Randomized Controlled Trial

Abstract

Background The metabolic syndrome is common across many complex chronic disease groups. Advances in health technology have provided opportunities to support lifestyle interventions. Objective The purpose of this study is to test the feasibility of a health technology-assisted lifestyle intervention in a patient-led model of care. Methods The study is a single-center, 26-week, randomized controlled trial. The setting is specialist kidney and liver disease clinics at a large Australian tertiary hospital. The participants will be adults with a complex chronic condition who are referred for dietetic assessment and display at least one feature of the metabolic syndrome. All participants will receive an individualized assessment and advice on diet quality from a dietitian, a wearable activity monitor, and standard care. Participants randomized to the intervention group will receive access to a suite of health technologies from which to choose, including common base components (text messages) and optional components (online and mobile app–based nutrition information, an online home exercise program, and group-based videoconferencing). Exposure to the optional aspects of the intervention will be patient-led, with participants choosing their preferred level of engagement. The primary outcome will be the feasibility of delivering the program, determined by safety, recruitment rate, retention, exposure uptake, and telehealth adherence. Secondary outcomes will be clinical effectiveness, patient-led goal attainment, treatment fidelity, exposure demand, and participant perceptions. Primary outcome data will be assessed descriptively and secondary outcomes will be assessed using an analysis of covariance. This study will provide evidence on the feasibility of the intervention in a tertiary setting for patients with complex chronic disease exhibiting features of the metabolic syndrome. Results The study was funded in 2019. Enrollment has commenced and is expected to be completed by June 2022. Data collection and follow up are expected to be completed by December 2022. Results from the analyses based on primary outcomes are expected to be submitted for publication by June 2023. Conclusions The study will test the implementation of a health technology–assisted lifestyle intervention in a tertiary outpatient setting for a diverse group of patients with complex chronic conditions. It is novel in that it embeds patient choice into intervention exposure and will inform health service decision-makers in regards to the feasibility of scale and spread of technology-assisted access to care for a broader reach of specialist services. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12620001282976; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378337 International Registered Report Identifier (IRRID) DERR1-10.2196/37556

Use of digital food records in clinical settings - lessons in translation from a randomised controlled trial

“…The U-DECIDE trial tested a technology-assisted lifestyle intervention to support patientled care between October 2020 and April 2022 in a large tertiary hospital in Brisbane, Australia. The published study protocol provides a detailed description of the study (12). This paper has been reported using the Consolidated criteria for reporting qualitative research (13) and Guidelines for Reporting Reliability and Agreement studies (14) (checklists provided in Supplementary Table S1 and S2).…”

Feasibility, Usability, and Safety of ParaGym, an Intelligent Mobile Exercise App for Individuals With Paraplegia: Protocol for a Pilot Block-Randomized Controlled Trial

“…Exercise diaries will be analyzed in terms of the frequency, duration, and intensity of the training sessions. Safety will be assessed by comparing the number of study-related AEs or SAEs in the intervention group with that in the waitlist control group [ 68 ].…”

Exercise, digital health and chronic disease: feasibility, effectiveness and utilisation (PhD Academy Award)

“…My thesis investigated the feasibility, effectiveness and utilisation of digital health physical activity/exercise interventions in chronic disease cohorts. Contemporary literature was reviewed for applicable digital health interventions,1 a feasibility randomised controlled trial was undertaken to evaluate the feasibility of a patient-centred digital health exercise and diet intervention for people living with kidney and liver disease in tertiary care,2 3 and the utilisation of telehealth exercise physiology (EP) services in Australia was examined 4…”

“…I conducted a feasibility randomised controlled trial assessing a patient-centred digital health diet and exercise intervention for people with complex chronic disease2 3 (U-DECIDE trial; n=67; (figure 1)). Participants in the intervention group chose their preferred level of engagement with digital health options.…”