Preoperative Lifestyle Intervention in Bariatric Surgery
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Severe Obesity
- Sponsor
- Duquesne University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- surgical complications and outpatient visits
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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.
Investigators
Melissa Kalarchian
Associate Professor
Duquesne University
Eligibility Criteria
Inclusion Criteria
- •Any candidate for weight loss surgery who is at least 18 years old \[At the University of Pittsburgh Medical Center, bariatric surgery is recommended as a treatment for individuals with Class III obesity (BMI \> 40), or Class II obesity (BMI 35- 40) and serious obesity-related health problems\]
Exclusion Criteria
- •Mental retardation or psychosis
- •Previously diagnosed genetic obesity syndrome
- •Participation in a structured weight management program in the 6 months prior to study enrollment
- •Uncontrolled psychiatric symptomatology sufficiently severe to require immediate treatment
- •Pregnant or lactating in the previous 6 months
- •Taking a medication known to affect body weight such as oral steroids in the previous 6 months
- •Any previous surgery for weight loss
- •Deemed high risk surgical candidate.
Outcomes
Primary Outcomes
surgical complications and outpatient visits
Time Frame: 6- and 12-months post surgery
weight and related outcomes (BMI, cardiovascular risk, quality of life)
Time Frame: pre and post intervention
preparation for surgery (eating, activity and knowledge of surgery)
Time Frame: pre and post intervention
compliance and eating problems (vomiting, dumping, plugging etc.)
Time Frame: 6- and 12-months post surgery
Secondary Outcomes
- Weight/BMI trajectory(pre- and post-intervention; 6-, 12 and 24 months postop)