Study on Impact of Lifestyle Change and Weight Loss Before Bariatric Surgery - Full Text View

Sponsors and Collaborators:	University of Pittsburgh National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00623792

Purpose

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.

Condition	Intervention
Severe Obesity Bariatric Surgery	Behavioral: Preoperative lifestyle Intervention

MedlinePlus related topics: Obesity Weight Control Weight Loss Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Preoperative Lifestyle Intervention in Bariatric Surgery

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

weight and related outcomes (BMI, cardiovascular risk, quality of life) [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]
preparation for surgery (eating, activity and knowledge of surgery) [ Time Frame: pre and post intervention ] [ Designated as safety issue: No ]
compliance and eating problems (vomiting, dumping, plugging etc.) [ Time Frame: 6- and 12-months post surgery ] [ Designated as safety issue: No ]
surgical complications and outpatient visits [ Time Frame: 6- and 12-months post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Weight/BMI trajectory [ Time Frame: pre- and post-intervention; 6-, 12 and 24 months postop ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention Usual preoperative care
2: Experimental Preoperative Lifestyle 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623792

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States

Sponsors and Collaborators

University of Pittsburgh

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Melissa A Kalarchian, PhD

WPIC/UPMC

More Information

Responsible Party:	WPIC, University of Pittsburgh Medical Center ( Melissa A. Kalarchian, PhD )
Study ID Numbers:	R01DK077102-01A1, R01DK077102-01A1
Study First Received:	February 14, 2008
Last Updated:	February 25, 2008
ClinicalTrials.gov Identifier:	NCT00623792
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Morbid obesity
Diet therapy
Bariatric Surgery
Gastric bypass

Behavior therapy
Randomized controlled trial
Weight loss

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 16, 2009