Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2015-10-31
2023-04-30
Brief Summary
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Detailed Description
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The aim of the study is to recruit 120 patients undergoing laparoscopic sleeve gastrectomy. These patients will be randomized to either the goal directed program or a standard program. Patient demographics, preoperative weight, and post operative weights at 3, 6, 9, 12, 18 and 24 months post laparoscopic sleeve gastrectomy will be collected. Univariate and multivariate analyses will be performed between each group with excess weight loss being the primary endpoint.
Such a trial would allow evaluation to know if the effort spent in implementing a goal directed weight loss program translates to improved weight loss outcomes in bariatric surgery patients. There are no significant risks involved in implementing such a program for our patients. This is based on a retrospective review of patients who have undergone the goal directed program in NUH. If such a program is shown to improve weight loss outcomes post surgery, it could potentially be adopted by bariatric centers worldwide. If the goal directed program is shown to have no bearing on weight loss outcomes, the extra efforts by the bariatric team into implementing such a program could be better directed to other endeavours.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Conventional Program
The aim of our study is to determine if a goal directed program improves weight loss outcomes after sleeve gastrectomy. In the conventional weight loss program, patients will only be given their ideal weight to strive toward after surgery. Routine dietary and physiotherapy/exercise counseling are provided and patients would be educated on their ideal weights based on a BMI of 23. The target weight loss over a 12 month period would be 100% excess weight loss.
Conventional Program
No scheduled intermediate weight loss goals provided to patient
Goal Directed Program
For the goal directed program, patients would be given an additional sheet to show expected weight loss goals to strive towards at each consultation after surgery (3, 6, 9 and 12 months post operation). Bariatric patients in this modified program will be counselled prior to laparoscopic sleeve gastrectomy (LSG) and EWL (excess weight loss) targets will be set for patients to achieve at fixed intervals post LSG. These targets are charted in a graph, with the patient's actual weight charted on the graph at each clinic consultation, providing a strong visual aid counselling and motivation.
Goal-directed Program
Scheduled program with intermediate weight loss targets reinforced to patients during follow up.
Interventions
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Conventional Program
No scheduled intermediate weight loss goals provided to patient
Goal-directed Program
Scheduled program with intermediate weight loss targets reinforced to patients during follow up.
Eligibility Criteria
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Inclusion Criteria
2. Age \>21 or \<65
3. BMI \>32.5 and \<45
4. Mentally Sound
5. Agreeable to commit to the length of follow up
6. Agreeable for randomization and signed consent form
Exclusion Criteria
2. Age \<21 or \>65
3. BMI \<32.5 or \>45
4. Previous Bariatric surgery
5. Mentally Unsound
6. Unable to commit to follow up schedule
7. Pregnant women or women who are breast-feeding
21 Years
65 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Locations
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National University Hospital
Singapore, , Singapore
Countries
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References
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Locke, E. A. (1996). Motivation through conscious goal setting. Applied and Preventive Psychology, 5(2), 117-124.
Wing, R. R. (2002). Behavioral weight control. Handbook of obesity treatment, 2, 301-317.
Wadden TA, Foster GD. Behavioral treatment of obesity. Med Clin North Am. 2000 Mar;84(2):441-61, vii. doi: 10.1016/s0025-7125(05)70230-3.
Kim G, Tan CS, Ng JY, Cheng AKS, Rao J, Soe KT, Kong LW, Naseer F, Er PSY, Lomanto D, So JBY, Shabbir A. Goal-directed program after sleeve gastrectomy improves weight loss. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):518-521. doi: 10.1016/j.soard.2015.11.014. Epub 2015 Nov 19.
Other Identifiers
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DSRB 2015/00744
Identifier Type: -
Identifier Source: org_study_id
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