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

Primary Purpose

Obesity

Status
Active
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Conventional Program
Goal-directed Program
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Program

Goal Directed Program

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean excess weight loss

Secondary Outcome Measures

Quality of life (SF36 questionaire)
Complications and adverse events
Remission of co-morbidities

Full Information

First Posted
June 21, 2016
Last Updated
April 7, 2022
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT02885220
Brief Title
Goal Directed Versus Conventional Weight Loss Program
Acronym
Go-Pro
Official Title
A Randomized Controlled Trial Comparing Goal Directed Versus Conventional Weight Loss Program Post Laparoscopic Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Goal Directed Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Program
Intervention Description
No scheduled intermediate weight loss goals provided to patient
Intervention Type
Other
Intervention Name(s)
Goal-directed Program
Intervention Description
Scheduled program with intermediate weight loss targets reinforced to patients during follow up.
Primary Outcome Measure Information:
Title
Mean excess weight loss
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life (SF36 questionaire)
Time Frame
12 months
Title
Complications and adverse events
Time Frame
12 months
Title
Remission of co-morbidities
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients having met the indications for laparoscopic sleevel gastrectomy, determined preoperatively by the attending surgeon Age >21 or <65 BMI >32.5 and <45 Mentally Sound Agreeable to commit to the length of follow up Agreeable for randomization and signed consent form Exclusion Criteria: No signed consent form Age <21 or >65 BMI <32.5 or >45 Previous Bariatric surgery Mentally Unsound Unable to commit to follow up schedule Pregnant women or women who are breast-feeding
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Locke, E. A. (1996). Motivation through conscious goal setting. Applied and Preventive Psychology, 5(2), 117-124.
Results Reference
background
Citation
Wing, R. R. (2002). Behavioral weight control. Handbook of obesity treatment, 2, 301-317.
Results Reference
background
PubMed Identifier
10793651
Citation
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.
Results Reference
background
PubMed Identifier
26944549
Citation
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.
Results Reference
background

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Goal Directed Versus Conventional Weight Loss Program

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