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

Bariatric Surgery Clinical Trial

— PREP  

Official title:

Preoperative Lifestyle Intervention in Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623792
• Other study ID #: R01DK077102-01A1
• Secondary ID: R01DK077102
• Status: Completed
• Phase: N/A
• First received: February 14, 2008
• Last updated: March 15, 2016
• Start date: March 2008
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity, Morbid
• Severe Obesity

Intervention

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

Locations

Country	Name	City	State
United States	Duquesne University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duquesne University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight and related outcomes (BMI, cardiovascular risk, quality of life)		pre and post intervention	No
Primary	preparation for surgery (eating, activity and knowledge of surgery)		pre and post intervention	No
Primary	compliance and eating problems (vomiting, dumping, plugging etc.)		6- and 12-months post surgery	No
Primary	surgical complications and outpatient visits		6- and 12-months post surgery	No
Secondary	Weight/BMI trajectory		pre- and post-intervention; 6-, 12 and 24 months postop	No