Feasibility of Use of BariCare App in Pre-bariatric Surgery.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01708135
Recruitment Status : Completed
First Posted : October 16, 2012
Last Update Posted : September 16, 2014
Information provided by (Responsible Party):
Manpreet S. Mundi, Mayo Clinic

Brief Summary:
This current study aims to evaluate the efficacy of engagement modules in preparing patients for bariatric surgery. With the help of the Center for Innovation (CFI), a smartphone app (Android and Apple compatible) has been created that will assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged during the lengthy pre-bariatric surgery process.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Use of smartphone app Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility and Efficacy of Engagement Modules for Pre-Bariatric Surgery Patients.
Study Start Date : October 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Smartphone Arm
This is a feasibility trial and thus all participants in the study will be provided a smartphone app to assist them in preparing for bariatric surgery.
Behavioral: Use of smartphone app

Primary Outcome Measures :
  1. Smart phone app feasibility [ Time Frame: 3 months ]
    All subjects will complete a Bariatric Surgery Questionnaire consisting of 30 questions that assess their knowldege in areas of nutrition, physical activity, and bariatric surgery. They will also be given a questionnaire on physical activity (International physical activity questionnaire or IPAQ). The primary objective is to assess improvement on both of these questionnaires with use of app.

Secondary Outcome Measures :
  1. Ease of use of app [ Time Frame: 3 months ]
    Through a questionnaire provided at the end of study, we will be gathering input from participants regarding ease of use of app, things they would like added or removed, as well as if they found modules helpful.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Patients, who upon completion of an evaluation by Endocrinology, are considered appropriate to pursue a primary, laparoscopic bariatric surgery.
  2. Patients who are 18 years of age or greater.
  3. Patients who own a smartphone.

Exclusion Criteria:

  1. Patients with a history of a prior bariatric surgery.
  2. Patients with active psychiatric disorder(s).
  3. Patients with active tobacco use.
  4. Patients with active substance use (alcohol, illicit drugs, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01708135

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Manpreet Mundi, MD Mayo Clinic

Responsible Party: Manpreet S. Mundi, Assistant Professor, Mayo Clinic Identifier: NCT01708135     History of Changes
Other Study ID Numbers: 12-005535
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: September 16, 2014
Last Verified: September 2014