Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000937516
Ethics application status
Approved
Date submitted
4/08/2015
Date registered
8/09/2015
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Does fortnightly telephone based support improve adherence to home exercise programs in obese clients awaiting bariatric surgery? A randomised controlled trial.
Scientific title
In obese (class II or III) patients awaiting bariatric surgery does fortnightly telephone based support compared with usual care lead to better adherence to a home exercise program?
Secondary ID [1] 287212 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 295807 0
Bariatric Surgery 295871 0
Condition category
Condition code
Diet and Nutrition 296069 296069 0 0
Obesity
Surgery 296122 296122 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention group will have fortnightly telephone based support for 12 weeks, by an Accredited Exercise Physiologist.

Telephone consults will range between 5 and 15 minutes, depending on the level of engagement and will be on a previously agreed upon date between the participant and exercise physiologist. During the telephone calls adherence to their home exercise programs will be discussed.

Home exercise programs will be individualised and tailored to participants' capacity but generally consist of an aerobic (walking) program as well as a progressive strengthening program to target goals set. Baseline steps per day will be used to set target goals for their walking program.

Objective data will be collected from a Fitbit Charge HR(TM) which is worn on the non-dominant wrist for 24 hour periods and measures heart rate, step count and activity level i.e. number of active minutes per week which can be transferred to the particpants' smartphone and stored on their personal profile via an application. Participants will also transfer their data into their activity log book daily, which will help remind them to charge their Fitbits. Staff will have access to their profiles through the Fitbit app and be able to view data prior to the telephone consult. Activity logs will be viewed at the end of the 12 week intervention only and compared to the staff-collected data.

All attempted phone calls will be logged in paper progress notes and duration of successful calls noted.
Intervention code [1] 292496 0
Lifestyle
Intervention code [2] 292497 0
Treatment: Other
Intervention code [3] 292550 0
Behaviour
Comparator / control treatment
Standard treatment will serve as the control.

Participants randomised to this group will receive a two week follow up phone call from an Exercise Physiologist post baseline testing and delivery of the home exercise program.

Telephone consults will range between 5 and 15 minutes, depending on the level of engagement and will be on a previously agreed upon date between the participant and exercise physiologist. During the telephone calls adherence to their home exercise programs will be discussed.

Home exercise programs will be individually tailored to participants' capacity but generally consist of an aerobic (walking) program as well as a progressive strengthening program to target goals set. Baseline steps per day will be used to set target goals for their walking program.

Objective data will be collected from a Fitbit Charge HR (TM) which is worn on the non-dominant wrist for 24 hour periods and measures heart rate, step count and activity level i.e. number of active minutes per week which can be transferred to the participants' smartphone and stored on their personal profile via an application. Participants will also transfer their data into their activity log book daily, which will help remind them to charge their Fitbits. Staff will have access to their profiles through the Fitbit app and be able to view data prior to the telephone consult. Activity logs will be viewed at the end of the 12 week intervention only and compared to the staff-collected data.

All attempted phone calls will be logged in paper progress notes and duration of successful calls noted.
Control group
Active

Outcomes
Primary outcome [1] 295743 0
adherence to home exercise program as assessed by number of active minutes per week (recorded by Fitbit).
Timepoint [1] 295743 0
at 12 weeks post randomisation.
Primary outcome [2] 295744 0
adherence to home exercise program as assessed by distance walked in 6 minute walking test.
Timepoint [2] 295744 0
baseline and at 12 weeks post randomisation
Secondary outcome [1] 316390 0
Body mass via digital scales.
Timepoint [1] 316390 0
Baseline and then 12 weeks later at the end of the intervention period.
Secondary outcome [2] 316391 0
Body Mass Index calculated using digital scales, stadiometer and a BMI calculator tool.
Timepoint [2] 316391 0
Baseline and then 12 weeks later at the end of the intervention period.
Secondary outcome [3] 316392 0
Lower limb strength as measured by 30 second chair stand test
Timepoint [3] 316392 0
Baseline and then 12 weeks later at the end of the intervention period.
Secondary outcome [4] 316393 0
Quality of Life as meaured by the Obesity and Weight Loss Quality of Life Instrument (OWLQOL) and Weight-related Symptom Measure (WRSM).
Timepoint [4] 316393 0
Baseline and then 12 weeks later at the end of the intervention period.
Secondary outcome [5] 316394 0
Step Count as measured by Fitbit Charge HR monitors and as assessed through self-reported activity logs.
Timepoint [5] 316394 0
Baseline and then 12 weeks later at the end of the intervention period.

Eligibility
Key inclusion criteria
i. Currently on the waiting list for bariatric surgery at The Queen Elizabeth Hospital, South Australia.
ii. Have a BMI>35 with comorbidities or >40 with/without comorbidities
iii. Have no medical conditions or physical or cognitive limitations that would prohibit the following of instructions and particpating safely in the exercise program and collection of outcome measures.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Inability to wear a Fitbit around the wrist
ii. No access to a computer and internet
iii. Patients not living within the Adelaide Metropolitan area
iv. People currently meeting the NHMRC phyical activity guidelines for weight loss.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients wanting to enrol in the study will be given the information sheet and have an appointment with an exercise physiologist who will complete a familiarisation session with the participants.
The following week, once baseline testing has been completed particpants will be randomised. Group allocation will be concealed in a sealed opaque envelope and completed over the telephone by an external contact.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be performed using a randomization table created by a computer software program i.e. computer sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A minimum of 23 participants are needed per group (46 in total) in order to detect 95% confidence interval, determined from a sample size calculator tool, based on expected outcomes using 6MWT distance as the primary outcome from a population of obese participants with knee osteoarthritis (on the assumption that these are similar). To allow for drop out and attrition we are looking to recruit 80 participants in total.

For each outcome measure collected, brief descriptive statistics, including means and standard deviations, both overall by age and gender will be calculated.
Pre and post functional testing results will be analysed through T-test statistics and differences in mean test scores by age group by ANOVA.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
12/10/2015
Actual
9/05/2016
Date of last participant enrolment
Anticipated
12/09/2017
Actual
6/03/2017
Date of last data collection
Anticipated
12/12/2017
Actual
6/06/2017
Sample size
Target
80
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4132 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 10063 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 291786 0
Hospital
Name [1] 291786 0
The Royal Adelaide Hospital Allied Health Research Grant 2015-2016.
Country [1] 291786 0
Australia
Primary sponsor type
Individual
Name
Joanna Ratcliffe
Address
The Centre for Physical Activity in Ageing
Hampstead Rehabilitation Centre
207-235 Hampstead Road
Lightsview
SA 5085
Country
Australia
Secondary sponsor category [1] 290450 0
Government body
Name [1] 290450 0
The Centre for Physical Activity in Ageing
Address [1] 290450 0
The Centre for Physical Activity in Ageing
Hampstead Rehabilitation Centre
207-235 Hampstead Road
Lightsview
SA 5085
Country [1] 290450 0
Australia
Other collaborator category [1] 278573 0
Hospital
Name [1] 278573 0
The Queen Elizabeth Hospital
Address [1] 278573 0
The Queen Elizabeth Hospital
28 Woodville Road
Woodville South
SA 5011
Country [1] 278573 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293305 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [1] 293305 0
Ethics committee country [1] 293305 0
Australia
Date submitted for ethics approval [1] 293305 0
06/08/2015
Approval date [1] 293305 0
13/08/2015
Ethics approval number [1] 293305 0
HREC/15/RAH/342

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 537 537 0 0
/AnzctrAttachments/369063-Participant information sheet.doc
Attachments [2] 547 547 0 0
/AnzctrAttachments/369063-150806 Ratcliffe - approval letter - HREC15RAH342 -signed.pdf

Contacts
Principal investigator
Name 59310 0
Miss Joanna Ratcliffe
Address 59310 0
Centre for Physical Activity in Ageing Hampstead Rehabilitation Centre 207-235 Hampstead Road Lightsview SA 5085
Country 59310 0
Australia
Phone 59310 0
+61 8 8222 1782
Fax 59310 0
+61 8 8222 1828
Email 59310 0
[email protected]
Contact person for public queries
Name 59311 0
Joanna Ratcliffe
Address 59311 0
Centre for Physical Activity in Ageing Hampstead Rehabilitation Centre 207-235 Hampstead Road Lightsview SA 5085
Country 59311 0
Australia
Phone 59311 0
+61 8 8222 1782
Fax 59311 0
+61 8 8222 1828
Email 59311 0
[email protected]
Contact person for scientific queries
Name 59312 0
Joanna Ratcliffe
Address 59312 0
Centre for Physical Activity in Ageing Hampstead Rehabilitation Centre 207-235 Hampstead Road Lightsview SA 5085
Country 59312 0
Australia
Phone 59312 0
+61 8 8222 1782
Fax 59312 0
+61 8 8222 1828
Email 59312 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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.