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

Phase 2

Suspended

• Conditions: Bariatric Surgery Complications
• Interventions: Behavioral: behavioral intervention

• Registration Number: NCT01860053
• Lead Sponsor: The Miriam Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2011-02
• Status Verified: 2013-05
• Study First Submitted: 2013-05-06
• Study First Submitted QC: 2013-05-19
• Last Update Submitted: 2013-05-19
• Study First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
behavioral intervention	behavioral intervention	-

Primary Outcome Measures

Name	Time	Method
change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview	baseline to week 6

Secondary Outcome Measures

Name	Time	Method
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	baseline to week 6

Trial Locations

Locations (1)

Weight Control and Diabetes Research Center; 🇺🇸 Providence, Rhode Island, United States