- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01122420
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program
August 21, 2013 updated by: Gretchen Purcell Jackson, Vanderbilt University
The purpose of this study is to determine whether different types of online health tools can aid overweight individuals in reducing their weight and managing their cardiovascular risk factors in the context of an employee wellness program.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt University
-
-
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
Description
Inclusion Criteria:
- Vanderbilt University employee
- Completion of the 2009 Go For the Gold Health Risk Assessment (HRA)
- Obesity defined by BMI > 30
- Identification of an additional risk factor on the HRA by either (a) a personal history of diabetes, high blood pressure, or high cholesterol or (b) a reported cholesterol >= 240 mg/dl, blood glucose >= 126 mg/dl, a systolic blood pressure >= 140 mm Hg, or a diastolic blood pressure >= 90 mm Hg
- Permission to be contacted regarding health on the HRA
Exclusion Criteria:
- Pregnant females and those who become pregnant prior to completion of the study
- Age younger than 18 years or older than 65 years
- Non English speaking individuals
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Goal-Setting Tool
|
Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal
|
Active Comparator: Health Web Sites
|
Access to publicly available health-related web sites
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body mass index
Time Frame: At enrollment and at 6 months
|
At enrollment and at 6 months
|
Change in excess body weight
Time Frame: At enrollment and at 6 months
|
At enrollment and at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gretchen P Jackson, M.D., Ph.D., Vanderbilt University
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
May 1, 2010
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
May 10, 2010
First Submitted That Met QC Criteria
May 10, 2010
First Posted (Estimate)
May 13, 2010
Study Record Updates
Last Update Posted (Estimate)
August 22, 2013
Last Update Submitted That Met QC Criteria
August 21, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 100021
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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