ClinicalTrials.gov
ClinicalTrials.gov Menu

Goal Directed Versus Conventional Weight Loss Program (Go-Pro)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02885220
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:
The aim of our study is to determine if the goal directed weight loss program improves weight loss versus the conventional weight loss program after laparoscopic sleeve gastrectomy.

Condition or disease Intervention/treatment Phase
Obesity Other: Conventional Program Other: Goal-directed Program Not Applicable

Detailed Description:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Mean excess weight loss [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quality of life (SF36 questionaire) [ Time Frame: 12 months ]
  2. Complications and adverse events [ Time Frame: 12 months ]
  3. Remission of co-morbidities [ Time Frame: 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients having met the indications for laparoscopic sleevel gastrectomy, determined preoperatively by the attending surgeon
  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:

  1. No signed consent form
  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

Information from the National Library of Medicine

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


Contacts
Contact: Kar Mun Mah, B.Sc +65 8163 5078 kar_mun_mah@nuhs.edu.sg
Contact: Elya Chen, B.Sc +65 8382 2690 surel@nus.edu.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119228
Contact: Asim Shabbir, MBBS    +65 9820 0814    cfsasim@nuhs.edu.sg   
Contact: Guowei Kim, MBBS    +65 9233 0548    guo_wei_kim@nuhs.edu.sg   
Sponsors and Collaborators
National University Hospital, Singapore

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02885220     History of Changes
Other Study ID Numbers: DSRB 2015/00744
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms