ObesityNCT02341001
Does Text Message Support After Discharge Improve Outcomes Following Bariatric Surgery? A Randomised Trial.
A study testing Daily text message of support in people with Obesity and Bariatric Surgery Candidate, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Bariatric Surgery Candidate
- What is being tested?
- Daily text message of support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients who have had a sleeve gastrectomy 18 months ago and are attending the discharge follow-up appointment
Who cannot join
- Patients who do not have the ability to receive text messages
- Patients who do not understand written English
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery.
- Conditions
- Obesity, Bariatric Surgery Candidate
- Being tested
- Daily text message of support
- Keywords
- Bariatric surgery, Sleeve gastrectomy, Text messaging, Weight loss, BAROS, Follow-up care
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily text message of supportOther
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patients are discharged from the bariatric service at 18 months after surgery. |
| Standard care with text message support | Experimental | Patients are discharged from the bariatric service at 18 months after surgery but receive a daily text message for one year. Receives: Other: Daily text message of support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of excess weight lost
Measured: Twelve months
Secondary outcomes (1)
Bariatric Analysis and Reporting Outcome System (BAROS)
Measured: Twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Collaborators
- Health Research Council, New Zealand
- Responsible party
- Principal investigator, Andrew MacCormick, University of Auckland, New Zealand
- Investigators
- Andrew D MacCormick, MBChB, PhD, Principal investigator, University of Auckland, New ZealandMelanie Lauti, MBChB, Principal investigator, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341001
- Sponsor's protocol ID
- BOBSRCT01
- Status last verified
- Oct 2017
- First submitted
- 24 Nov 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 29500678
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT02341001
- Acronym / sponsor ID
- BOBSRCT01
- Conditions
- Obesity, Bariatric Surgery Candidate
- Keywords
- Bariatric surgery, Sleeve gastrectomy, Text messaging, Weight loss, BAROS, Follow-up care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Health Research Council, New Zealand
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patients are discharged from the bariatric service at 18 months after surgery. |
| Standard care with text message support | Experimental | Other: Daily text message of supportPatients are discharged from the bariatric service at 18 months after surgery but receive a daily text message for one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who have had a sleeve gastrectomy 18 months ago and are attending the discharge follow-up appointment
Key exclusion criteria (2 listed)
- Patients who do not have the ability to receive text messages
- Patients who do not understand written English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily text message of support | Other | Standard care with text message support |
Primary outcome
Percent of excess weight lost
Time frame: Twelve months
1 secondary outcome
Bariatric Analysis and Reporting Outcome System (BAROS)
Time frame: Twelve months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
- Derived from this study: PubMed 29500678Lauti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D MacCormick, MBChB, PhD principal investigator
University of Auckland, New Zealand
Melanie Lauti, MBChB principal investigator
University of Auckland, New Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily text message of support in people with Obesity and Bariatric Surgery Candidate, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of excess weight lost (time frame: Twelve months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341001, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2017.