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

Duquesne University300 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Severe Obesity Bariatric Surgery

Interventions

Preoperative lifestyle InterventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duquesne University

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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 Outcomes

Weight/BMI trajectory

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

Data from ClinicalTrials.gov

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