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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bariatric Surgery Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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behavioral intervention

Group Type EXPERIMENTAL

behavioral intervention

Intervention Type BEHAVIORAL

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

no treatment control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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behavioral intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No