- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01607177
Do Text Message Reminders Increase Preoperative Exercise in Obesity Surgery Candidates?
November 12, 2013 updated by: SACS, University of Auckland, New Zealand
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
102
Phase
- Phase 3
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
-
-
Manukau City
-
Auckland, Manukau City, New Zealand, 2241
- Manukau Surgery Centre
-
-
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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre
- Operation used primarily for the treatment of morbid obesity
Exclusion Criteria:
- Operation not performed at Manukau Surgery Centre
- Patient does not have a mobile phone which can receive text messages
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Text message group
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.
|
Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.
|
|
No Intervention: No text message group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks post recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Physical Activity
Time Frame: 6 weeks postoperatively
|
Quantity of physical acitivty will be measured as METmins per week as measured by the IPAQ questionnaire
|
6 weeks postoperatively
|
|
Functional capacity
Time Frame: Baseline and 6 weeks post recuitment (preoperatively)
|
Measured using the 6 minute walk test
|
Baseline and 6 weeks post recuitment (preoperatively)
|
|
Length of Hospital Stay
Time Frame: As assessed at day of discharge
|
Total number of days spent in hospital following their operation
|
As assessed at day of discharge
|
|
Short term weight loss
Time Frame: Out to 6 months postoperatively
|
Postoperative weight loss as measured by percentage of excess weight loss
|
Out to 6 months postoperatively
|
|
Perioperative complications
Time Frame: Out to 30 days postoperatively
|
Prospectively recorded postoperative complications graded according the Clavien-Dindo classification system
|
Out to 30 days postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrew G Hill, MBChB, MD, EdD, FRACS, FACS, South Auckland Clinical School, University of Auckland
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
August 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
May 24, 2012
First Submitted That Met QC Criteria
May 25, 2012
First Posted (Estimate)
May 28, 2012
Study Record Updates
Last Update Posted (Estimate)
November 14, 2013
Last Update Submitted That Met QC Criteria
November 12, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bariatric Prehabilitation
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.
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