NCT01197937

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

1.9 years

First QC Date

September 2, 2010

Last Update Submit

December 10, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

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

    12 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology in Psychiatry and Surgery at The Perelman School of Medicine

Study Record Dates

First Submitted

September 2, 2010

First Posted

September 9, 2010

Study Start

August 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 11, 2013

Record last verified: 2013-12