A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients

The Miriam Hospital5 enrolled

Overview

The purpose of this study is to reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bariatric Surgery Complications

Interventions

behavioral interventionBEHAVIORAL

This intervention targets eating behavior to reduce vomiting and associated complications in post-operative LAGB patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age between 18 and 70 years. 2. Received LAGB surgery with either a standard Lap-Band or a standard Realize Band. 3. Report vomiting at least 3x/week. 4. Agree to allow researchers to communicate with their surgeon regarding their care. 5. Fulfilled all hospital surgery criteria. Exclusion Criteria: 1. Report a condition that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol (e.g., major illness, plans to move out of the area, substance abuse or other significant psychiatric problems, organic brain disease). 2. Report planning to become pregnant during the time frame of the investigation. 3. Report a history of upper gastrointestinal dismotility.

Locations (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview

Time frame: baseline to week 6

Secondary Outcomes

change in gastrointestinal symptom severity - questionnaire measures severity of various GI symptoms over the previous week and items are summed yielding an overall GI severity index

Time frame: baseline to week 6

Data from ClinicalTrials.gov

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