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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623792
First Posted: February 26, 2008
Last Update Posted: March 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Melissa Kalarchian, Duquesne University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Lifestyle Intervention in Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Melissa Kalarchian, Duquesne University:

Primary Outcome Measures:
  • 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 ]
  • surgical complications and outpatient visits [ Time Frame: 6- and 12-months post surgery ]

Secondary Outcome Measures:
  • Weight/BMI trajectory [ Time Frame: pre- and post-intervention; 6-, 12 and 24 months postop ]

Enrollment: 300
Study Start Date: March 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623792


Locations
United States, Pennsylvania
Duquesne University
Pittsburgh, Pennsylvania, United States, 15282
Sponsors and Collaborators
Duquesne University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Melissa A Kalarchian, PhD Duquesne University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Melissa Kalarchian, Associate Professor, Duquesne University
ClinicalTrials.gov Identifier: NCT00623792     History of Changes
Other Study ID Numbers: R01DK077102-01A1 ( U.S. NIH Grant/Contract )
R01DK077102 ( U.S. NIH Grant/Contract )
First Submitted: February 14, 2008
First Posted: February 26, 2008
Last Update Posted: March 17, 2016
Last Verified: March 2016

Keywords provided by Melissa Kalarchian, Duquesne University:
Morbid obesity
Diet therapy
Bariatric Surgery
Gastric bypass
Behavior therapy
Randomized controlled trial
Weight loss

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