Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000476932
Ethics application status
Approved
Date submitted
12/03/2020
Date registered
15/04/2020
Date last updated
15/04/2020
Date data sharing statement initially provided
15/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Design of a Theory-based Mobile Health Coaching App for Surgery in Obese Patients: A Study Protocol
Scientific title
User-centred Design of a Theory-based, Ontology-driven Mobile Health Coaching App for Fitness before Surgery in Obese Patients: A Study Protocol
Secondary ID [1] 300785 0
none
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 316647 0
diet and nutrition 316716 0
Condition category
Condition code
Surgery 314891 314891 0 0
Other surgery
Diet and Nutrition 315065 315065 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Material: A mobile app will be developed to provide multi-disciplinary health coaching
Procedure: Patients will log on to the app, complete a questionnaire to describe their current health status. The app will direct them to health resources, send them 4 coaching notifications a week, and will track their progress towards their self-nominated goals. Participants will be able to use the app as often as they wish.
Delivery: automatically via the mobile phone app
Duration: the study will cease at 6 months, or earlier if a person has their scheduled surgery before 6 months
Location: in participants' own time and space
Content: examples of coaching notifications include:
Diet: "Make sure you eat a rainbow of different colours of fruit and vegetables to reach your nutrition needs", "Cutting down your food proportions slowly over time will create long term changes"
Exercise: "Walking for 30 minutes a day improves heart and lung health", "Aim to increase your daily step count by 500 steps this week"
Psychology: "By making repeated small changes in habits, most people can reach their goals. You can too", " All of us can do with a little support from time to time. Do you know that you can talk to your GP about your mental well being?"
Medical: "Need some extra help reaching your goals this week? Contact NSW Get Healthy on xxxxx for free lifestyle coaching'
Intervention code [1] 317107 0
Treatment: Other
Comparator / control treatment
no control group, as this first trial is a pilot study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323213 0
change in weight

All outcomes will be self-reported as entered into the app
Timepoint [1] 323213 0
For each participant, the study will end 6 months after enrolment or at the time of surgery, whichever happens first.
Secondary outcome [1] 381188 0
Change in physical activity using the International Physical Activity Questionnaire
Timepoint [1] 381188 0
For each participant, the study will end 6 months after enrolment or at the time of surgery, whichever happens first.
Secondary outcome [2] 381379 0
Change in nutrition, using the Australian Bureau of Statistics, Australian Health Survey short questions
Timepoint [2] 381379 0
For each participant, the study will end 6 months after enrolment or at the time of surgery, whichever happens first.
Secondary outcome [3] 381380 0
Change in health engagement, using the Patient Activation Measure
Timepoint [3] 381380 0
For each participant, the study will end 6 months after enrolment or at the time of surgery, whichever happens first.

Eligibility
Key inclusion criteria
Age >=18yr, body mass index >= 30 kg/m2, booking for elective surgery with a Category C (up to 12 months) waiting period
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
not having a smartphone, difficulties understanding English

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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
Efficacy
Statistical methods / analysis
This is a pilot study. Our sample size will be based on convenience, with approximately 50-100 patients. Statistics will be mainly descriptive. Changes at the end of the study will be compared to baseline measures from the beginning of the study using t-tests with continuous parametric data, and ordinal measures for non-parametric data.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
1/12/2020
Actual
Date of last data collection
Anticipated
1/05/2021
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16114 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 29632 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 305243 0
University
Name [1] 305243 0
University of Wollongong, Illawarra Health and Medical Research Institute
Country [1] 305243 0
Australia
Primary sponsor type
Individual
Name
Dr Natalie Smith
Address
c/o Wollongong Hospital, Crown St, Wollongong. NSW 2500
Country
Australia
Secondary sponsor category [1] 305599 0
None
Name [1] 305599 0
Address [1] 305599 0
Country [1] 305599 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305586 0
UOW and ISLHD Health and Medical Human Research Comittee
Ethics committee address [1] 305586 0
Ethics committee country [1] 305586 0
Australia
Date submitted for ethics approval [1] 305586 0
Approval date [1] 305586 0
23/07/2019
Ethics approval number [1] 305586 0
2019/ETH03698

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

Contacts
Principal investigator
Name 100866 0
Dr Natalie Smith
Address 100866 0
Dept Anaesthesia, Wollongong Hospital, Crown St, Wollongong, NSW 2500
Country 100866 0
Australia
Phone 100866 0
+61 0439473790
Fax 100866 0
Email 100866 0
[email protected]
Contact person for public queries
Name 100867 0
Natalie Smith
Address 100867 0
Dept Anaesthesia, Wollongong Hospital, Crown St, Wollongong, NSW 2500
Country 100867 0
Australia
Phone 100867 0
+61 0439473790
Fax 100867 0
Email 100867 0
[email protected]
Contact person for scientific queries
Name 100868 0
Natalie Smith
Address 100868 0
Dept Anaesthesia, Wollongong Hospital, Crown St, Wollongong, NSW 2500
Country 100868 0
Australia
Phone 100868 0
+61 0439473790
Fax 100868 0
Email 100868 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
Patient information will be collected individually, but kept anonymous for analysis and study purposes


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7349Study protocol  [email protected] 379452-(Uploaded-12-03-2020-14-43-57)-Study-related document.docx



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.