Goal Directed Versus Conventional Weight Loss Program

Not Applicable

• Conditions: Obesity
• Interventions: Other: Conventional Program; Other: Goal-directed Program

• Registration Number: NCT02885220
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-31
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-14
• Primary Completion: 2022-09
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Program	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.
Goal Directed Program	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.

Primary Outcome Measures

Name	Time	Method
Mean excess weight loss	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of life (SF36 questionaire)	12 months
Complications and adverse events	12 months
Remission of co-morbidities	12 months

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore