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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/NCT02341001
Registration number
NCT02341001
Ethics application status
Date submitted
24/11/2014
Date registered
19/01/2015
Date last updated
27/10/2017
Titles & IDs
Public title
Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial.
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Scientific title
Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial and Sub-study of the BOBS Study (Better Outcomes Following Bariatric Surgery)
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Secondary ID [1]
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BOBSRCT01
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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:
Obesity
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Bariatric Surgery Candidate
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Daily text message of support
No Intervention: Standard care - Patients are discharged from the bariatric service at 18 months after surgery.
Experimental: Standard care with text message support - Patients are discharged from the bariatric service at 18 months after surgery but receive a daily text message for one year.
Other interventions: Daily text message of support
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Intervention code [1]
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Other interventions
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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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Percent of excess weight lost
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Assessment method [1]
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Timepoint [1]
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Twelve months
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Secondary outcome [1]
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Bariatric Analysis and Reporting Outcome System (BAROS)
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Assessment method [1]
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Timepoint [1]
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Twelve months
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Eligibility
Key inclusion criteria
- All patients who have had a sleeve gastrectomy 18 months ago and are attending the
discharge follow-up appointment
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Patients who do not have the ability to receive text messages
- Patients who do not understand written English
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Study design
Purpose of the study
Supportive Care
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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
Not Applicable
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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
1/01/2015
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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
1/01/2017
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Sample size
Target
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Accrual to date
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Final
110
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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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Auckland
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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
The purpose of this study is to determine whether text message support after discharge from a
bariatric service improves outcomes following bariatric surgery.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02341001
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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 D MacCormick, MBChB, PhD
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Address
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University of Auckland, New Zealand
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02341001
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