NCT01122420

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started May 2010

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

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

May 1, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

3.3 years

First QC Date

May 10, 2010

Last Update Submit

August 21, 2013

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (2)

  • Change in body mass index

    At enrollment and at 6 months

  • Change in excess body weight

    At enrollment and at 6 months

Study Arms (2)

Goal-Setting Tool

EXPERIMENTAL
Other: Goal-Setting Tool

Health Web Sites

ACTIVE COMPARATOR
Other: Health Web Sites

Interventions

Goal-Setting ToolOTHER

Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal

Goal-Setting Tool
Health Web SitesOTHER

Access to publicly available health-related web sites

Health Web Sites

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gretchen P Jackson, M.D., Ph.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 10, 2010

First Posted

May 13, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

US(1)