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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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.
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)
Secondary ID [1] 0 0
BOBSRCT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Bariatric Surgery Candidate 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent of excess weight lost
Timepoint [1] 0 0
Twelve months
Secondary outcome [1] 0 0
Bariatric Analysis and Reporting Outcome System (BAROS)
Timepoint [1] 0 0
Twelve months

Eligibility
Key inclusion criteria
- All patients who have had a sleeve gastrectomy 18 months ago and are attending the
discharge follow-up appointment
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients who do not have the ability to receive text messages

- Patients who do not understand written English

Study design
Purpose of the study
Supportive Care
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
Not Applicable
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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
The purpose of this study is to determine whether text message support after discharge from a
bariatric service improves outcomes following bariatric surgery.
Trial website
https://clinicaltrials.gov/show/NCT02341001
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew D MacCormick, MBChB, PhD
Address 0 0
University of Auckland, New Zealand
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
Other publications