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

May 19, 2013 updated by: Tricia M. Leahey, Ph.D., The Miriam Hospital
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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 3

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
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Weight Control and Diabetes Research Center

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 to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: behavioral intervention
Behavioral: behavioral intervention
This intervention targets eating behavior to reduce vomiting and associated complications in post-operative LAGB patients.
No Intervention: no treatment control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview
Time Frame: baseline to week 6
baseline to week 6

Secondary Outcome Measures

Outcome Measure
Time Frame
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
baseline to week 6

Collaborators and Investigators

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

Sponsor

The Miriam Hospital

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

May 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 19, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Estimate)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 19, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2030-09

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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