NCT01860053

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
5

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

May 6, 2013

Last Update Submit

May 19, 2013

Conditions

Bariatric Surgery Complications

Outcome Measures

Primary Outcomes (1)

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

    baseline to week 6

Secondary Outcomes (1)

  • 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

Study Arms (2)

behavioral intervention

EXPERIMENTAL
Behavioral: behavioral intervention

no treatment control

NO INTERVENTION

Interventions

behavioral interventionBEHAVIORAL

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

behavioral intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years.
  • Received LAGB surgery with either a standard Lap-Band or a standard Realize Band.
  • Report vomiting at least 3x/week.
  • Agree to allow researchers to communicate with their surgeon regarding their care.
  • Fulfilled all hospital surgery criteria.

You may not qualify if:

  • 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).
  • Report planning to become pregnant during the time frame of the investigation.
  • Report a history of upper gastrointestinal dismotility.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Interventions

Behavior Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

May 6, 2013

First Posted

May 22, 2013

Study Start

May 1, 2009

Primary Completion

February 1, 2011

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

US(1)