Goal Directed Versus Conventional Weight Loss Program (Go-Pro)
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|ClinicalTrials.gov Identifier: NCT02885220|
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Other: Conventional Program Other: Goal-directed Program||Not Applicable|
The aim of our study is to determine if a goal directed program improves weight loss outcomes after sleeve gastrectomy. Bariatric patients are managed by a multidisciplinary team comprising of bariatric surgeons, dieticians, physiotherapists, and physicians. In the conventional weight loss program, patients were only given their ideal weight to strive toward after surgery. Previous patients undergoing bariatric surgery in the standard program often enquired about the expected excessive weight loss targets after bariatric surgery. This patient driven need led to the development of the goal directed weight loss program. This modified program involves a component of behavioural intervention. Bariatric patients in this modified program will be counselled prior to LSG and EWL targets will be set for patients to achieve at fixed intervals post LSG. These targets are charted on a graph, with the patient's actual weight charted on the same graph at each clinic consultation, providing a strong visual aid to counseling and motivation.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Controlled Trial Comparing Goal Directed Versus Conventional Weight Loss Program Post Laparoscopic Sleeve Gastrectomy|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Active Comparator: 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.
Other: Conventional Program
No scheduled intermediate weight loss goals provided to patient
Experimental: 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.
Other: Goal-directed Program
Scheduled program with intermediate weight loss targets reinforced to patients during follow up.
- Mean excess weight loss [ Time Frame: 12 months ]
- Quality of life (SF36 questionaire) [ Time Frame: 12 months ]
- Complications and adverse events [ Time Frame: 12 months ]
- Remission of co-morbidities [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885220
|Contact: Kar Mun Mah, B.Sc||+65 8163 email@example.com|
|Contact: Elya Chen, B.Sc||+65 8382 firstname.lastname@example.org|
|National University Hospital||Recruiting|
|Singapore, Singapore, 119228|
|Contact: Asim Shabbir, MBBS +65 9820 0814 email@example.com|
|Contact: Guowei Kim, MBBS +65 9233 0548 firstname.lastname@example.org|