- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02341001
Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial.
October 26, 2017 updated by: Andrew MacCormick, University of Auckland, New Zealand
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)
The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
110
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Auckland, New Zealand
- Counties Manukau District Health Board
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All patients who have had a sleeve gastrectomy 18 months ago and are attending the discharge follow-up appointment
Exclusion Criteria:
- Patients who do not have the ability to receive text messages
- Patients who do not understand written English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Standard care
Patients are discharged from the bariatric service at 18 months after surgery.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Percent of excess weight lost
Time Frame: Twelve months
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Twelve months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Bariatric Analysis and Reporting Outcome System (BAROS)
Time Frame: Twelve months
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Twelve months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of re-referrals to the bariatric clinic
Time Frame: Twelve months
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Twelve months
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Cost comparison
Time Frame: Twelve months
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Very basic cost comparison will be performed by calculating the cost of each intervention and comparing them.
Items included in the cost analysis will be the cost of text messaging and the costs incurred if patients in the study were reviewed by the bariatric team after re-referral.
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Twelve months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew D MacCormick, MBChB, PhD, University of Auckland, New Zealand
- Principal Investigator: Melanie Lauti, MBChB, University of Auckland, New Zealand
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2015
Primary Completion (Actual)
January 1, 2017
Study Completion (Actual)
January 1, 2017
Study Registration Dates
First Submitted
November 24, 2014
First Submitted That Met QC Criteria
January 13, 2015
First Posted (Estimate)
January 19, 2015
Study Record Updates
Last Update Posted (Actual)
October 27, 2017
Last Update Submitted That Met QC Criteria
October 26, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- BOBSRCT01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.