Duquesne University
Pittsburgh, Pennsylvania, 15282, United States
NCT Number: NCT00623792
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Pittsburgh, Pennsylvania, 15282, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: pre and post intervention
Time frame: pre and post intervention
Time frame: 6- and 12-months post surgery
Time frame: 6- and 12-months post surgery
Time frame: pre- and post-intervention; 6-, 12 and 24 months postop
Duquesne University
Other
Preoperative Lifestyle Intervention in Bariatric Surgery
Acronym: PREP
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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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