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Completed

NCT Number: NCT00623792

Study on Impact of Lifestyle Change and Weight Loss Before 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preoperative lifestyle Intervention

Behavioral

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

Primary outcomes

  1. weight and related outcomes (BMI, cardiovascular risk, quality of life)

    Time frame: pre and post intervention

  2. preparation for surgery (eating, activity and knowledge of surgery)

    Time frame: pre and post intervention

  3. compliance and eating problems (vomiting, dumping, plugging etc.)

    Time frame: 6- and 12-months post surgery

  4. surgical complications and outpatient visits

    Time frame: 6- and 12-months post surgery

Secondary outcomes

  1. Weight/BMI trajectory

    Time frame: pre- and post-intervention; 6-, 12 and 24 months postop

Sponsors and collaborators

Lead sponsor

Duquesne University

Other

Collaborators

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

Registry information

Official study title

Preoperative Lifestyle Intervention in Bariatric Surgery

Acronym: PREP

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2008
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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