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Clinical Trials/NCT01197937
NCT01197937CompletedNot Applicable

Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

University of Pennsylvania0 sites25,000 target enrollmentStarted: August 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25,000
Primary Endpoint
Assess changes in body weight in frequent v. infrequent RMS users

Study Overview

Brief 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Assess changes in body weight in frequent v. infrequent RMS users

Time Frame: 12 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Sarwer

Professor of Psychology in Psychiatry and Surgery at The Perelman School of Medicine

University of Pennsylvania

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