NCT01607177

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

May 24, 2012

Last Update Submit

November 12, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks post recruitment

Secondary Outcomes (5)

  • Postoperative Physical Activity

    6 weeks postoperatively

  • Functional capacity

    Baseline and 6 weeks post recuitment (preoperatively)

  • Length of Hospital Stay

    As assessed at day of discharge

  • Short term weight loss

    Out to 6 months postoperatively

  • Perioperative complications

    Out to 30 days postoperatively

Study Arms (2)

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.

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.

Interventions

Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.

Text message group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre
  • Operation used primarily for the treatment of morbid obesity

You may not qualify if:

  • Operation not performed at Manukau Surgery Centre
  • Patient does not have a mobile phone which can receive text messages

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manukau Surgery Centre

Auckland, Manukau City, 2241, New Zealand

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew G Hill, MBChB, MD, EdD, FRACS, FACS

    South Auckland Clinical School, University of Auckland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Andrew G. Hill

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

August 1, 2012

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations