Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

Obesity Clinical Trial

Official title:

Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197937
• Other study ID #: 29372
• Status: Completed
• Phase: N/A
• First received: September 2, 2010
• Last updated: December 10, 2013
• Start date: August 2010
• Est. completion date: July 2012

Study information

• Verified date: December 2013
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a website that allows patients and providers to maintain contact via the website. We will compare RMS users on a number of different variables with the goal of identifying which variables are associated with optimal outcomes (larger weight losses) at one year (and potentially beyond). The study has two primary objectives. The first is to assess changes in body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that frequent users will achieve significantly greater reductions in weight at 6 and 12 months (and beyond) than infrequent users. The second objective is to assess changes in body weight at postoperative year 1 in persons who use different features of the RMS site. We hypothesize that persons who, on a regular basis, record their food intake, track their physical activity and make specific behavioral goals will experience significantly greater reductions in weight beginning 6 months after surgery as compared to those who do not use these features of the RMS site.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25000
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18-65 years old

• BMI between 40-70 kg/m2 (or 35-70 kg/m2 in the presence of co-morbidities)

• Have registered in the Realize Mysuccess Systema and have logged into the system at least once postoperatively.

Exclusion Criteria:

• We will be receiving/analyzing a data set based on the inclusion criteria, therefore there is no set exclusion criteria for our research.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity
• Weight Loss

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Ethicon Endo-Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess changes in body weight in frequent v. infrequent RMS users		12 months	No