Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01607177




Registration number
NCT01607177
Ethics application status
Date submitted
24/05/2012
Date registered
28/05/2012
Date last updated
14/11/2013

Titles & IDs
Public title
Do Text Message Reminders Increase Preoperative Exercise in Obesity Surgery Candidates?
Scientific title
Text Messaging to Improve Adherence to Prehabilitation in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
Secondary ID [1] 0 0
Bariatric Prehabilitation
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perioperative Care 0 0
Bariatric Surgery 0 0
Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Daily text message reminders

Experimental: Text message group - Patients randomised to this group will receive daily text message reminders used to motivate them to exercise in the preoperative period. They will also receive an exercise information sheet to complement the text messages.

No Intervention: No text message group - Patients randomised to this group will receive standardised exercise advice but will not receive the text message reminders or the exercise information sheet.


Behaviour: Daily text message reminders
Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of patients partaking in the minimum recommended amount of weekly physical activity
Timepoint [1] 0 0
6 weeks post recruitment
Secondary outcome [1] 0 0
Postoperative Physical Activity
Timepoint [1] 0 0
6 weeks postoperatively
Secondary outcome [2] 0 0
Functional capacity
Timepoint [2] 0 0
Baseline and 6 weeks post recuitment (preoperatively)
Secondary outcome [3] 0 0
Length of Hospital Stay
Timepoint [3] 0 0
As assessed at day of discharge
Secondary outcome [4] 0 0
Short term weight loss
Timepoint [4] 0 0
Out to 6 months postoperatively
Secondary outcome [5] 0 0
Perioperative complications
Timepoint [5] 0 0
Out to 30 days postoperatively

Eligibility
Key inclusion criteria
- Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre

- Operation used primarily for the treatment of morbid obesity
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Operation not performed at Manukau Surgery Centre

- Patient does not have a mobile phone which can receive text messages

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)
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Manukau City

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Health Research Council, New Zealand
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Preoperative exercise has been shown to improve physiological and functional capacity in
patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients
undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the
setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is
also thought to increase the likelihood that they will exercise postoperatively. However,
compliance to this advice is extremely low. Text-message interventions have been shown to
improve compliance to other lifestyle interventions. The investigators will compare the rate
of compliance to preoperative exercise prior to bariatric surgery in patients who receive a
daily text message to those who do not. The investigators will also compare weight loss.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01607177
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew G Hill, MBChB, MD, EdD, FRACS, FACS
Address 0 0
South Auckland Clinical School, University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01607177