NCT01708135

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

1.9 years

First QC Date

October 8, 2012

Last Update Submit

September 15, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Smart phone app feasibility

    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.

    3 months

Secondary Outcomes (1)

  • Ease of use of app

    3 months

Study Arms (1)

Smartphone Arm

OTHER

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

Interventions

Smartphone Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Manpreet Mundi, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 16, 2012

Study Start

October 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 16, 2014

Record last verified: 2014-09

Locations