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/study/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
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.
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
Sex
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
Other
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
NA
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
1/01/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2017
Sample size
Target
Accrual to date
Final
110
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/study/NCT02341001
Trial related presentations / publications
Lauti M, Kularatna M, Pillai A, Hill AG, MacCormick AD. A Randomised Trial of Text Message Support for Reducing Weight Regain Following Sleeve Gastrectomy. Obes Surg. 2018 Aug;28(8):2178-2186. doi: 10.1007/s11695-018-3176-1.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02341001