NCT02885220

Goal Directed Versus Conventional Weight Loss Program

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	Conventional Program	No scheduled intermediate weight loss goals provided to patient
OTHER	Goal-directed Program	Scheduled program with intermediate weight loss targets reinforced to patients during follow up.

Timeline

• Start date: 2015-10-01
• Primary completion: 2022-09-01
• Completion: 2023-04-01
• First posted: 2016-08-31
• Last updated: 2022-04-14

Locations

1 site across 1 country: Singapore