Perioperative CarePhase 3NCT01607177
Do Text Message Reminders Increase Preoperative Exercise in Obesity Surgery Candidates?
A Phase 3 study testing Daily text message reminders in people with Perioperative Care and Bariatric Surgery, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
Preoperative exercise has been shown to improve physiological and functional capacity in patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients undergoing bariatric surgery are advised to partake in regular preoperative exercise. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Perioperative Care, Bariatric Surgery, Obesity
- What is being tested?
- Daily text message reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 2012to Sep 2013
- Phase
- Phase 3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre
- Operation used primarily for the treatment of morbid obesity
Who cannot join
- Operation not performed at Manukau Surgery Centre
- Patient does not have a mobile phone which can receive text messages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Text Messaging to Improve Adherence to Prehabilitation in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
Preoperative exercise has been shown to improve physiological and functional capacity in patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is also thought to increase the likelihood that they will exercise postoperatively. However, compliance to this advice is extremely low. Text-message interventions have been shown to improve compliance to other lifestyle interventions. The investigators will compare the rate of compliance to preoperative exercise prior to bariatric surgery in patients who receive a daily text message to those who do not. The investigators will also compare weight loss.
- Conditions
- Perioperative Care, Bariatric Surgery, Obesity
- Being tested
- Daily text message reminders
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily text message remindersBehavioural
Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.
| Study group | Role | What they receive |
|---|---|---|
| Text message group | Experimental | Patients randomised to this group will receive daily text message reminders used to motivate them to exercise in the preoperative period. They will also receive an exercise information sheet to complement the text messages. Receives: Behavioral: Daily text message reminders |
| No text message group | No intervention | Patients randomised to this group will receive standardised exercise advice but will not receive the text message reminders or the exercise information sheet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients partaking in the minimum recommended amount of weekly physical activity
>450 METmins per week of physical activity as measured by the internationally and locally validated IPAQ questionnaire.
Measured: 6 weeks post recruitment
Secondary outcomes (5)
Postoperative Physical Activity
Quantity of physical acitivty will be measured as METmins per week as measured by the IPAQ questionnaire
Measured: 6 weeks postoperatively
Functional capacity
Measured using the 6 minute walk test
Measured: Baseline and 6 weeks post recuitment (preoperatively)
Length of Hospital Stay
Total number of days spent in hospital following their operation
Measured: As assessed at day of discharge
Short term weight loss
Postoperative weight loss as measured by percentage of excess weight loss
Measured: Out to 6 months postoperatively
Perioperative complications
Prospectively recorded postoperative complications graded according the Clavien-Dindo classification system
Measured: Out to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative CareStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 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, SACS, University of Auckland, New Zealand
- Investigators
- Andrew G Hill, MBChB, MD, EdD, FRACS, FACS, Principal investigator, South Auckland Clinical School, University of Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607177
- Sponsor's protocol ID
- Bariatric Prehabilitation
- Status last verified
- Nov 2013
- First submitted
- 24 May 2012
- Last updated
- 14 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Improve Adherence to Prehabilitation in Patients Undergoing Bariatric Surgery: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01607177
- Acronym / sponsor ID
- Bariatric Prehabilitation
- Conditions
- Perioperative Care, Bariatric Surgery, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Collaborators
- Health Research Council, New Zealand
- Study start
- Aug 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 28 May 2012 (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.
Preoperative exercise has been shown to improve physiological and functional capacity in patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is also thought to increase the likelihood that they will exercise postoperatively. However, compliance to this advice is extremely low. Text-message interventions have been shown to improve compliance to other lifestyle interventions. The investigators will compare the rate of compliance to preoperative exercise prior to bariatric surgery in patients who receive a daily text message to those who do not. The investigators will also compare weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text message group | Experimental | Behavioral: Daily text message remindersPatients randomised to this group will receive daily text message reminders used to motivate them to exercise in the preoperative period. They will also receive an exercise information sheet to complement the text messages. |
| No text message group | No intervention | –Patients randomised to this group will receive standardised exercise advice but will not receive the text message reminders or the exercise information sheet. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre
- Operation used primarily for the treatment of morbid obesity
Key exclusion criteria (2 listed)
- Operation not performed at Manukau Surgery Centre
- Patient does not have a mobile phone which can receive text messages
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 remindersDaily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet. | Behavioural | Text message group |
Primary outcome
Proportion of patients partaking in the minimum recommended amount of weekly physical activity
Time frame: 6 weeks post recruitment
>450 METmins per week of physical activity as measured by the internationally and locally validated IPAQ questionnaire.
5 secondary outcomes
Postoperative Physical Activity
Time frame: 6 weeks postoperatively
Functional capacity
Time frame: Baseline and 6 weeks post recuitment (preoperatively)
Length of Hospital Stay
Time frame: As assessed at day of discharge
Short term weight loss
Time frame: Out to 6 months postoperatively
Perioperative complications
Time frame: Out to 30 days postoperatively
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 14 Nov 2013.
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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 G Hill, MBChB, MD, EdD, FRACS, FACS principal investigator
South Auckland Clinical School, University of Auckland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Daily text message reminders in people with Perioperative Care and Bariatric Surgery, 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 2 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 14 Nov 2013. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Proportion of patients partaking in the minimum recommended amount of weekly physical activity (time frame: 6 weeks post recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2013.