Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery

December 10, 2013 updated by: David Sarwer, University of Pennsylvania
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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess changes in body weight in frequent v. infrequent RMS users
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Ethicon Endo-Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 8, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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