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Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01197937
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : December 11, 2013
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Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Bariatric Surgery Obesity Weight Loss

Study Design

Study Type : Observational
Actual Enrollment : 25000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery
Study Start Date : August 2010
Primary Completion Date : July 2012
Study Completion Date : July 2012

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U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Assess changes in body weight in frequent v. infrequent RMS users [ Time Frame: 12 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be men and women, 18-65 years old, with a BMI of 40-70 kg/m2 (or 35-70 kg/m2 in the presence of co-morbidities) who have registered in the RMS system and have log into the system at least once postoperatively.
Criteria

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.
More Information

Responsible Party: David Sarwer, Professor of Psychology in Psychiatry and Surgery at The Perelman School of Medicine, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01197937     History of Changes
Other Study ID Numbers: 29372
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms