Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620001282976
Ethics application status
Approved
Date submitted
20/10/2020
Date registered
27/11/2020
Date last updated
5/04/2023
Date data sharing statement initially provided
27/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
U:DECIDE Study: Utilising technology for Diet & Exercise Change In complex chronic conditions across Diverse Environments
Scientific title
A randomised controlled trial utilising health technologies to deliver and support lifestyle interventions to improve cardio metabolic risk in individuals with complex chronic disease.
Secondary ID [1] 299228 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
U:DECIDE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiometabolic Health 314364 0
Solid Organ Transplant Recipients 314365 0
Chronic Kidney Disease 314366 0
Metabolic Syndrome 314367 0
Condition category
Condition code
Diet and Nutrition 312697 312697 0 0
Obesity
Cardiovascular 312698 312698 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 312699 312699 0 0
Other physical medicine / rehabilitation
Metabolic and Endocrine 312700 312700 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The objective of this research is to determine whether health technologies can be utilised in specialist chronic disease clinics to deliver lifestyle interventions to improve the management of cardiometabolic risk in individuals with complex chronic conditions.
There will be two groups; an intervention group and a control group randomised to a 1:1 ratio.
Intervention:
- Participants will undergo education for increasing physical activity in line with Australian National Guidelines (30minutes daily, up to 150minutes per week of aerobic and resistance activity) and aligning with heart healthy dietary eating patterns. The Healthy heart dietary education will focus on increasing intake of fruit/veg/wholegrains/healthy proteins, reduction of foods with added salt/sugars and promotion of healthy fat choices such as nuts and olive oil). Education is focused on food choice and dietary pattern with no specific education around weight reduction even though weight loss may occur as a result of dietary change.
The intervention will last for 26 weeks. All intervention participants will receive a one-on-one baseline dietary assessment and education session with an accredited practicing dietitian. The first session will be one-on-one for the health professional to determine any individual specific needs, but all remaining appointments will be group base and delivered via telehealth or technology assisted contact such as online information or text messages. Participants will receive an information booklet and then can choose a range of review strategies including group video 1hr dietitian review (offered monthly), group video 1hr exercise sessions (offered weekly), text message support with frequency from 1 - 3 per week to reinforce advice, information, motivation and support to improve diet and physical activity behaviours support. This booklet has been designed specifically for the study and is not publicly available at this stage. Participants will also be provided with a fitbit wearable device to track physical activity patterns and intensity. Participants will have access to online dietary education videos, recipes and information via a private web platform and/or mobile app. Monitoring of individual access to the online material will not be tracked, but rather whole group de-identified access of app will be observed with web analytics. Fidelity of the service delivery will be assessed by regular supervision of the intervention appointments by principal investigators and professional support and case discussions at weekly team meetings. It will be up to the participant to decide the frequency of which they would like this additional support.
Adherence and compliance with the model of care will be assessed at each session by the health professional. Log books to record exercise sessions and diet tracking checklists will assist in recording adherence to recommendations for diet and exercise.
The intervention will be delivered via the Queensland Health Portal whereby participants will log in online from their personal device (computer/laptop/ipad/smart phone) with the health professional located centrally at the Princess Alexandra Hospital or University of Queensland and multiple participants logging in to each appointment for a group session. There will be no web analytic analysis of individuals accessing the portal.
Intervention code [1] 315531 0
Lifestyle
Comparator / control treatment
The control group will receive standard clinic care. Participants in this group will receive routine care from their treating physician(s) and routine nutrition care from their clinic dietitian. There is no exercise physiology service offered as part of usual care. In additional to standard clinic care they will receive the same information booklet as the intervention group and a fitbit heart rate monitor. Standard dietetic care practices may differ between different chronic disease clinics; however, there will be no change to frequency of usual physician or dietetic consultations or service delivery throughout the study to this group.
Control group
Active

Outcomes
Primary outcome [1] 321446 0
The primary outcome will evaluate the feasibility of technology assisted patient-led lifestyle interventions to inform future implementation of this model of care into usual practice assessed at the end of the 26-week program.

Feasibility criteria were prospectively set as follows:
Success of feasibility will be confirmed if the intervention was safe (Safety was assessed by comparing the number of study-related serious adverse events (SRSAEs) in the intervention and comparator groups) and at least three of the following four criteria were fulfilled: i) Recruitment: greater than or equal to 50% of all referred eligible patients were recruited, ii) Retention: greater than or equal to 70% of participants underwent an end-of-program assessment, iii) Exposure Uptake: greater than or equal to 75% of intervention participants had a higher frequency of specialist outpatient dietetic and exercise specialist contact than the comparators , and iv) Telehealth Adherence: videoconferencing-facilitated dietetic and exercise sessions had an attendance rate of at least 80% of the total scheduled contacts.

Recruitment rate will be measured as the number of patients recruited from the pool of eligible patients referred to dietetics and invited to participate within a 6 month recruitment period. Reason for not recruited will be recorded. Data will be extracted from audit of study screening logs.

Retention rate will be calculated as the inverse of attrition (due to drop-out or safety concerns) at 26 weeks in both study groups. Retention will also explore the demographics and clinical characteristics of those participants that drop out compared to those remaining in the trial. Data will be extracted from audit of study enrolment and end of study attendance logs.

Exposure Uptake: Due to the nature of patient choice embedded into the intervention, the range of exposure to the intervention delivery across the participant groups will be documented. This will include capturing the range of combinations of request to access technology to support health behaviour change including number and frequency of text messages requested, number of group telehealth diet and exercise appointments booked. Exposure uptake will be assessed by tallying number of review appointments and contacts by a health professional during the trial period in both intervention and comparator group.

Telehealth adherence will be assessed by documented attendance to schedule diet and exercise telehealth review sessions in the intervention group as reviewed by attendance logs.

Safety: The safety of the intervention will be monitored and any study-related serious adverse events of interest (cardiac, orthopaedic, musculoskeletal) including hospitalisation, symptom development or injury will be recorded and compared to the comparator group. All charts will be audited for hospital admissions during the trial period and all participants will be asked at end of study if any adverse events occurred that have not been previously recorded.
The criteria for safety and feasibility have been chosen based on a thorough review of feasibility studies in the literature, the desire for non-inferiority outcomes from current usual care and the need for sustainability if this model of care was to be rolled out in real world practice.
Timepoint [1] 321446 0
week 0 and week 26
Secondary outcome [1] 374974 0
The secondary outcomes will evaluate the clinical effectiveness of the program on reducing cardiometabolic risk, and the economic impact of the program. The outcomes will be assessed using the following measures: 1. Clinical Effectiveness - assessed at baseline (pre-randomisation) and repeated at 26 weeks •

MetS Severity Score: A MetS Severity Score based on clinical thresholds from an Australian population, will be calculated - This is a z-score calculated as continuous risk assessment score. MetS severity score is calculated using the five parameters of the MetS including: waist circumference (measuring tape to nearest 0.5 centimetre), systolic blood pressure (SBP) measured as mean of three assessments with automatic sphygmomanometer with 1 min rest in between measures, fasting serum triglycerides, HDL-cholesterol and glucose. The score calculated gives an indication of MetS status compared to others. A score below 0 indicates a lower degree of MetS than the average adult, a score close to 0 indicates an average degree of MetS. Scores over 0 are associated with greater risk for future disease and scores >1 indicate high prevalence MetS.
The MetSSS will also be calculated using the Wiley formula.
Timepoint [1] 374974 0
week 0 and week 26
Secondary outcome [2] 374975 0
Economic analysis will be from a health services perspective - hospital admissions, ED presentations, specialist and hospital allied health appointments and pathology costs. This data will be retrospectively extracted from the hospital case-mix coding data linked to participants occasions of service and pathology records at end of study and compared between those int he intervention and comparator groups
Timepoint [2] 374975 0
Week 26
Secondary outcome [3] 374976 0
Participant satisfaction and acceptability (mixed method) Using semi-structured interviews with a subset of purposively sampled intervention participants
Timepoint [3] 374976 0
Week 26
Secondary outcome [4] 389098 0
Dietary Quality: Dietary data collected using the research version of the Easy Diet Diary phone app (Research Food Diary) and analysed in FoodWorks (version 10). This data will be used to compare dietary quality of both groups at baseline and post intervention as measured by dietary intake changes from baseline in serves per day of (i) core food groups (fruit, vegetables, meats and alternatives, dairy and alternatives, and grains and cereals); (ii) fibre; and (iii) discretionary food
Timepoint [4] 389098 0
Week 0 and Week 26
Secondary outcome [5] 389099 0
Quality of Life will be measured using the EQ-5D-5L Quality of life questionnaire
Timepoint [5] 389099 0
Week 0 and Week 26
Secondary outcome [6] 389100 0
Confidence: Likert scales of patient’s perception of confidence in managing their diet and exercise will be measured.
Timepoint [6] 389100 0
Week 0 and Week 26
Secondary outcome [7] 389101 0
Physical Activity and Physical Function: The International Physical Activity Questionnaire (IPAQ) long form survey will be used to measure habitual physical activity and sedentary behaviour. Weekly time spent in moderate and vigorous physical activity will be measured by a wearable activity monitor. Physical function will be determined by functional tests: sit-to-stand, grip strength and 6-min walk tests, measured by a trained health practitioner.
Timepoint [7] 389101 0
Week 0 and Week 26
Secondary outcome [8] 389102 0
Fatigue will be measured using the FACIT fatigue scale version 4
Timepoint [8] 389102 0
Week 0 and Week 26
Secondary outcome [9] 389103 0
Sleep quality and quantity will be measured using the Pittsburgh sleep quality index (PSQI) survey and collection of sleep data from the wearable activity monitor (total minutes awake, minutes of REM sleep, minutes of light sleep, minutes of deep sleep and an overall sleep quality score rated out of 100)
Timepoint [9] 389103 0
Week 0 and Week 26

Eligibility
Key inclusion criteria
Participants will be considered eligible when they meet the following inclusion criteria:
a) Aged greater than or equal to 18 years
b) Under the care of at least one of the following Princess Alexandra hospital specialist clinics (liver, renal) or under the care of the Ipswich hospital chronic kidney disease clinic;
c) Have at least one of the following features of MetS: hypertension, obesity (by BMI >30kg/m2 or central obesity), dyslipidemia (raised fasting triglyceride or low HDL cholesterol), raised fasting glucose or type 2 diabetes;
d) Screened as safe to exercise unsupervised;
e) Deemed medically suitable to participate by their treating specialist;
f) Have current access to a phone/mobile device or computer hardware with internet access and capabilities for webcam attachment; and
g) Provide written informed consent.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
This study will exclude participants that do not satisfy the above inclusion criteria, or:
a) Deemed unsafe to participate by their treating specialist;
b) Non-English speaking; and/or unable to read and write in English.
c) No access to phone/mobile device
d) Malnourished (defined by subjective global assessment)
e) Pregnancy
f) Have a physical disability that whereby an increase in physical activity would be deemed inappropriate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomised 1:1 to either a Technology-assisted lifestyle intervention group (n=84) for 26 weeks or usual care for 26 weeks (n=84).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation and stratification sequence generation will be performed by an independent statistician.
Randomisation will be implemented by the trial coordinator using the REDCap research management system which will implement the statisticians schedule. Randomisation will be stratified across x3 strata based on disease condition (liver disease, renal disease, post-transplant). The investigator will use sealed envelopes to distribute group allocation and inform the consenting participant of their assigned intervention at their baseline appointment, after the baseline assessments have been provided.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Investigators performing outcome measures will be blinded to group allocation.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a feasibility pilot study that will be used to inform the design of a larger effectiveness trial. The statistical analysis of the feasibility variables will be largely descriptive. Some of the clinical variables will use pre-post analysis such as ANCOVA.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Covid-impacts on recruitment and mass disruption to hospital outpatient service provision meant slower than expected recruitment and therefore exhaustion of funding prior to recruitment target being met. Adequate recruitment for primary outcome measure had been met and so it was decided to cease further recruitment.
Date of first participant enrolment
Anticipated
11/12/2020
Actual
11/12/2020
Date of last participant enrolment
Anticipated
1/12/2021
Actual
5/11/2021
Date of last data collection
Anticipated
1/07/2022
Actual
3/06/2022
Sample size
Target
168
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14829 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28081 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303767 0
Government body
Name [1] 303767 0
Queensland Health Health Practitioner Research Scheme
Country [1] 303767 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Rd
Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 303887 0
None
Name [1] 303887 0
Address [1] 303887 0
Country [1] 303887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304288 0
MetroSouth Health and Hospital Services Human Research Ethics Committee
Ethics committee address [1] 304288 0
Ethics committee country [1] 304288 0
Australia
Date submitted for ethics approval [1] 304288 0
01/11/2019
Approval date [1] 304288 0
25/09/2020
Ethics approval number [1] 304288 0
HREC/2019/QMS/58285
Ethics committee name [2] 307133 0
University of Queensland Human Research Ethics Committee
Ethics committee address [2] 307133 0
Ethics committee country [2] 307133 0
Australia
Date submitted for ethics approval [2] 307133 0
25/09/2020
Approval date [2] 307133 0
08/10/2020
Ethics approval number [2] 307133 0
2020000127

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96406 0
Dr Ingrid Hickman
Address 96406 0
Dept Nutrition and Dietetics Ground Floor, Building 15 Princess Alexandra Hospital Ipswich Rd Woolloongabba Qld 4102
Country 96406 0
Australia
Phone 96406 0
+61 7 3176 5588
Fax 96406 0
+61 7 3176 5619
Email 96406 0
[email protected]
Contact person for public queries
Name 96407 0
Ingrid Hickman
Address 96407 0
Dept Nutrition and Dietetics Ground Floor, Building 15 Princess Alexandra Hospital Ipswich Rd Woolloongabba Qld 4102
Country 96407 0
Australia
Phone 96407 0
+61 7 3176 5588
Fax 96407 0
+61 7 3176 5619
Email 96407 0
[email protected]
Contact person for scientific queries
Name 96408 0
Ingrid Hickman
Address 96408 0
Dept Nutrition and Dietetics Ground Floor, Building 15 Princess Alexandra Hospital Ipswich Rd Woolloongabba Qld 4102
Country 96408 0
Australia
Phone 96408 0
+61 7 3176 5588
Fax 96408 0
+61 7 3176 5619
Email 96408 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.