Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001084673
Ethics application status
Approved
Date submitted
20/09/2023
Date registered
16/10/2023
Date last updated
16/10/2023
Date data sharing statement initially provided
16/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Technology Assisted Dietary Assessment and Advice
(TADAA) Feasibility Study
Scientific title
A non-randomised, single-arm, feasibility trial of a tailored digital approach targeting diet quality in cardiac surgery patients
Secondary ID [1] 310655 0
Nil known
Universal Trial Number (UTN)
Trial acronym
TADAA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 331552 0
Condition category
Condition code
Cardiovascular 328281 328281 0 0
Coronary heart disease
Diet and Nutrition 328282 328282 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be a non-randomised, single-arm, open-label feasibility trial to test the feasibility of technology-assisted dietary assessment and advice to improve overall diet quality in cardiac surgery patients.

Participants will be required to record all food and beverage intake over four consecutive days (including one weekend day) at baseline (T0 pre-surgery) and at 4 weeks after baseline (T4 pre-surgery) both before surgery, and at 6 weeks after surgery (T6 post-surgery) using a mobile food record (mFR trademark) app. Participants will also be asked to record all food and beverage intake over a 24-hour period using the mFR trademark app at 2 weeks after baseline (T2 pre-surgery) and every 4 weeks after T4 prior to until surgery. Participants will be on varying wait periods for surgery and therefore the intervention will be standardised for the first four weeks.

Participants will be asked to label vegetables on their images to be aware and conscious of increasing intake as a strategy to improve overall diet quality. Within 7 days of recording food and beverage intake, participants will receive tailored dietary advice based on their dietary assessment with the aim of increasing vegetables and improving overall diet quality consistent with the National Heart Foundation Dietary Position Statement on Heart Healthy Eating Patterns.

A research dietitian with tertiary dietetic qualifications will deliver the intervention. Additional training will be completed for the analysis of image-based food records and behaviour change interview techniques for improving diet quality.

Dietary advice will be provided via a one-hour dietetic telehealth consultation at baseline and 15 min dietetic check-in appointments at 2 and 4 weeks after baseline (before surgery) and at 6 weeks after surgery. A dietary summary designed by the dietitian will be emailed to participants after the initial consultation and supportive SMS messages will be provided after each dietetic check-in appointment (e.g., look for pre-made salads or veggie bowls at your grocery store or local deli).

A purposefully sampled group of participants (approx. 10-15) will be invited to take part in a semi-structured in-depth online or telephone interview, to further explore acceptability of the image-assisted mFR trademark method and features (e.g., labelling).

Participants will be deemed adherent if they have completed at least 75% of the prescribed food and beverage recording days (i.e., four days) using the mFR trademark app at baseline and 4 weeks after baseline (before surgery) and at 6 weeks after surgery. Complete recording days will be defined as at least one meal recorded in a day.


Intervention code [1] 327062 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336143 0
Our primary outcome will be feasibility, determined by achieving all three of the following:
(1) 30 participants recruited
(2) >=80% of participants receiving the intervention for at least 4 weeks
(3) >=80% of participants achieving intervention adherence
Timepoint [1] 336143 0
At the conclusion of the study.
Secondary outcome [1] 427057 0
Change in vegetable intake
Timepoint [1] 427057 0
Baseline, Week 4 (pre-surgery) and Week 6 (post-surgery)
Secondary outcome [2] 427435 0
Change in overall diet quality
Timepoint [2] 427435 0
Baseline, Week 4 (pre-surgery) and Week 6 (post-surgery)

Eligibility
Key inclusion criteria
Participants will be included if they are adults scheduled for elective cardiac surgery with a wait time greater than 4 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants excluded if they do not own a smartphone with internet and data packages, are pregnant, surgery is scheduled after the 9-month recruitment window, currently participating in an existing nutrition intervention study or those unable/unwilling to understand and/or follow the study protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample size calculation
The sample size calculation is based on intervention adherence. It is estimated that at least 80% of patients will be adherent based on our previous studies. With n=30 patients, the 95% confidence interval (CI) around a compliance point estimate of 0.80 is 0.66-0.94. RCTs have demonstrated meaningful changes with dietary interventions with compliance levels below the lower 95% CI margin of 0.66.

Quantitative analysis
The analysis of primary feasibility outcomes will be assessed using a 95%CI for a proportion. Secondary outcomes will be analysed using linear mixed models to provide increased power compared to a paired t-test and address missing data. We will obtain post-estimation marginal means for baseline and post-intervention and the difference in marginal means with 95% confidence interval and p-values. A 2-sided Type 1 error rate of alpha=0.05 will be used for testing statistical significance. However, the focus of the secondary outcomes will be to collect estimates regarding the magnitude of dietary change to inform our future large-scale RCT.

Qualitative analysis
Interview content will be transcribed verbatim and NVivo software will be used to thematically analyse data. The collection and reporting of qualitative data will adhere to the consolidated criteria for reporting qualitative research (COREQ).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2023
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 314872 0
University
Name [1] 314872 0
Edith Cowan University
Country [1] 314872 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 316870 0
University
Name [1] 316870 0
Curtin University
Address [1] 316870 0
GPO Box U 1987 Perth, Western Australia 6845
Country [1] 316870 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313869 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 313869 0
Ethics committee country [1] 313869 0
Australia
Date submitted for ethics approval [1] 313869 0
26/07/2022
Approval date [1] 313869 0
13/09/2022
Ethics approval number [1] 313869 0
RGS0000005461
Ethics committee name [2] 313870 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [2] 313870 0
Ethics committee country [2] 313870 0
Australia
Date submitted for ethics approval [2] 313870 0
01/08/2022
Approval date [2] 313870 0
10/08/2022
Ethics approval number [2] 313870 0
1979
Ethics committee name [3] 313871 0
Curtin University Human Research Ethics Committee
Ethics committee address [3] 313871 0
Ethics committee country [3] 313871 0
Australia
Date submitted for ethics approval [3] 313871 0
09/12/2022
Approval date [3] 313871 0
16/12/2022
Ethics approval number [3] 313871 0
HRE2022-0670
Ethics committee name [4] 313872 0
Edith Cowan University Human Research Ethics Commmittee
Ethics committee address [4] 313872 0
Ethics committee country [4] 313872 0
Australia
Date submitted for ethics approval [4] 313872 0
08/12/2022
Approval date [4] 313872 0
21/12/2022
Ethics approval number [4] 313872 0
2022-03996-BLEKKENHORST

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

Contacts
Principal investigator
Name 129618 0
Dr Lauren Blekkenhorst
Address 129618 0
Edith Cowan University, 270 Joondalup Drive Joondalup WA 6027
Country 129618 0
Australia
Phone 129618 0
+61 8 63044604
Fax 129618 0
Email 129618 0
[email protected]
Contact person for public queries
Name 129619 0
Lauren Blekkenhorst
Address 129619 0
Edith Cowan University, 270 Joondalup Drive Joondalup WA 6027
Country 129619 0
Australia
Phone 129619 0
+61 8 63044604
Fax 129619 0
Email 129619 0
[email protected]
Contact person for scientific queries
Name 129620 0
Lauren Blekkenhorst
Address 129620 0
Edith Cowan University, 270 Joondalup Drive Joondalup WA 6027
Country 129620 0
Australia
Phone 129620 0
+61 8 63044604
Fax 129620 0
Email 129620 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.