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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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?
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Scientific title
Text Messaging to Improve Adherence to Prehabilitation in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
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Secondary ID [1]
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Bariatric Prehabilitation
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Perioperative Care
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Bariatric Surgery
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Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - 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.
BEHAVIORAL: Daily text message reminders
Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of patients partaking in the minimum recommended amount of weekly physical activity
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Assessment method [1]
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\>450 METmins per week of physical activity as measured by the internationally and locally validated IPAQ questionnaire.
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Timepoint [1]
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6 weeks post recruitment
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Secondary outcome [1]
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Postoperative Physical Activity
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Assessment method [1]
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Quantity of physical acitivty will be measured as METmins per week as measured by the IPAQ questionnaire
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Timepoint [1]
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6 weeks postoperatively
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Secondary outcome [2]
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Functional capacity
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Assessment method [2]
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Measured using the 6 minute walk test
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Timepoint [2]
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Baseline and 6 weeks post recuitment (preoperatively)
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Secondary outcome [3]
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Length of Hospital Stay
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Assessment method [3]
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Total number of days spent in hospital following their operation
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Timepoint [3]
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As assessed at day of discharge
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Secondary outcome [4]
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Short term weight loss
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Assessment method [4]
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Postoperative weight loss as measured by percentage of excess weight loss
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Timepoint [4]
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Out to 6 months postoperatively
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Secondary outcome [5]
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Perioperative complications
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Assessment method [5]
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Prospectively recorded postoperative complications graded according the Clavien-Dindo classification system
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Timepoint [5]
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Out to 30 days postoperatively
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Eligibility
Key inclusion criteria
* Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre
* Operation used primarily for the treatment of morbid obesity
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Minimum age
20
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Operation not performed at Manukau Surgery Centre
* Patient does not have a mobile phone which can receive text messages
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
102
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Manukau City
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Health Research Council, New Zealand
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01607177
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Andrew G Hill, MBChB, MD, EdD, FRACS, FACS
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Address
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South Auckland Clinical School, University of Auckland
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01607177
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