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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Manpreet S. Mundi, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01708135
First received: October 8, 2012
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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 Intervention
Obesity
Behavioral: Use of smartphone app

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Feasibility and Efficacy of Engagement Modules for Pre-Bariatric Surgery Patients.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Smart phone app feasibility [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Ease of use of app [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: October 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708135

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

No publications provided

Responsible Party: Manpreet S. Mundi, Assistant Professor, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01708135     History of Changes
Other Study ID Numbers: 12-005535
Study First Received: October 8, 2012
Last Updated: September 15, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014