Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

This study has been completed.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
David Sarwer, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01197937
First received: September 2, 2010
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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
Bariatric Surgery
Obesity
Weight Loss

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Assess changes in body weight in frequent v. infrequent RMS users [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 25000
Study Start Date: August 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: September 2, 2010
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on April 17, 2014