NCT00623792

Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery

Preoperative Lifestyle Intervention in Bariatric Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Duquesne University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to determine whether a preoperative lifestyle intervention (targeting diet, exercise, and preparation for surgery) will favorably impact obesity-related parameters prior to bariatric surgery and improve short-term postoperative outcomes.

Detailed description

This is a randomized, controlled trial to evaluate the impact of a preoperative lifestyle intervention that targets diet, exercise, and preparation for surgery as an adjunct to the surgical treatment of obesity. Patients will be randomized to a 6-month lifestyle intervention (n = 100) or to usual care (n = 100) prior to undergoing bariatric surgery. We aim to evaluate the effect of the intervention on select pre- and postoperative outcomes. We hypothesize that patients who participate in the preoperative intervention will exhibit greater improvements in weight and related outcomes and better preparation for surgery than those who receive usual care. After operation, we hypothesize that patients who participate in the intervention will exhibit better compliance and fewer behavior-related eating problems, as well as a lower rate of complications and fewer outpatient visits with surgery-related conditions than those who received usual preoperative care. Our secondary aim is to determine whether the intervention affects weight/BMI trajectory through 24 months after operation.

Conditions

• Severe Obesity
• Bariatric Surgery

Interventions

Type	Name	Description
BEHAVIORAL	Preoperative lifestyle Intervention	6 month individual intervention consisting of weekly face-to-face and telephone sessions addressing diet, activity and preparation for surgery, followed by 3 "booster" telephone calls after surgery

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2008-02-26
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States