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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01708135
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• 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: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

1. Smart phone app feasibility [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Manpreet Mundi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Manpreet S. Mundi, Assistant Professor, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT01708135
• Other Study ID Numbers: 12-005535
• First Posted: Oct 16, 2012
• Last Update Posted: Sep 16, 2014
• Last Verified: Sep 1, 2014

Study Results

No Results Posted as of Sep 16, 2014