Goal Directed Versus Conventional Weight Loss Program

Obesity Clinical Trial

— Go-Pro  

Official title:

A Randomized Controlled Trial Comparing Goal Directed Versus Conventional Weight Loss Program Post Laparoscopic Sleeve Gastrectomy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02885220
• Other study ID #: DSRB 2015/00744
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: April 2023

Study information

• Verified date: April 2022
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (4)

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. — View Citation

Locke, E. A. (1996). Motivation through conscious goal setting. Applied and Preventive Psychology, 5(2), 117-124.

Wadden TA, Foster GD. Behavioral treatment of obesity. Med Clin North Am. 2000 Mar;84(2):441-61, vii. Review. — View Citation

Wing, R. R. (2002). Behavioral weight control. Handbook of obesity treatment, 2, 301-317.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean excess weight loss		12 months
Secondary	Quality of life (SF36 questionaire)		12 months
Secondary	Complications and adverse events		12 months
Secondary	Remission of co-morbidities		12 months