Online Resources to Manage Obesity and Health Risks in an... | NCT01122420

Studies
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program

NCT01122420

Sponsor

Vanderbilt University

Status

Completed

Last Update Posted

Aug 22, 2013Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

Goal-Setting Tool
Health Web Sites

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Aug 2013Actual

Completion Date

Aug 2013Actual

First Submitted Date

May 10, 2010

First Submission Date that Met QC Criteria

May 10, 2010

First Posted Date

May 13, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2013

Last Update Posted Date

Aug 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Goal-Setting Tool	Experimental		Other: Goal-Setting Tool
Health Web Sites	Active Comparator		Other: Health Web Sites

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Goal-Setting Tool	Other	Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal	Goal-Setting Tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in body mass index		At enrollment and at 6 months
Change in excess body weight		At enrollment and at 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gretchen P Jackson, M.D., Ph.D.	Vanderbilt University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanderbilt University		Nashville	Tennessee	37232	United States

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided