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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Melissa Kalarchian, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00623792
First received: February 14, 2008
Last updated: June 12, 2012
Last verified: February 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Lifestyle Intervention in Bariatric Surgery

Resource links provided by NLM:


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
No Intervention: 1
Usual preoperative care
Experimental: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Melissa A Kalarchian, PhD WPIC/UPMC
  More Information

No publications provided

Responsible Party: Melissa Kalarchian, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00623792     History of Changes
Other Study ID Numbers: R01DK077102-01A1, R01DK077102-01A1
Study First Received: February 14, 2008
Last Updated: June 12, 2012
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

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014