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

March 15, 2016 updated by: Melissa Kalarchian, Duquesne University

Preoperative Lifestyle Intervention in Bariatric Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15282
        • Duquesne University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
weight and related outcomes (BMI, cardiovascular risk, quality of life)
Time Frame: pre and post intervention
pre and post intervention
preparation for surgery (eating, activity and knowledge of surgery)
Time Frame: pre and post intervention
pre and post intervention
compliance and eating problems (vomiting, dumping, plugging etc.)
Time Frame: 6- and 12-months post surgery
6- and 12-months post surgery
surgical complications and outpatient visits
Time Frame: 6- and 12-months post surgery
6- and 12-months post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight/BMI trajectory
Time Frame: pre- and post-intervention; 6-, 12 and 24 months postop
pre- and post-intervention; 6-, 12 and 24 months postop

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duquesne University

Collaborators

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

Investigators

  • Principal Investigator: Melissa A Kalarchian, PhD, Duquesne University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

February 25, 2008

First Posted (Estimate)

February 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK077102-01A1 (U.S. NIH Grant/Contract)
  • R01DK077102 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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