ObesityNCT01122420
Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program
A study testing Goal-Setting Tool and Health Web Sites in people with Obesity, run by Vanderbilt University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Goal-Setting Tool and Health Web Sites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity
- Being tested
- Goal-Setting Tool, Health Web Sites
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Setting ToolOther
Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal
Health Web SitesOther
Access to publicly available health-related web sites
| Study group | Role | What they receive |
|---|---|---|
| Goal-Setting Tool | Experimental | Not described Receives: Other: Goal-Setting Tool |
| Health Web Sites | Active comparator | Not described Receives: Other: Health Web Sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index
Measured: At enrollment and at 6 months
Change in excess body weight
Measured: At enrollment and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startMay 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gretchen Purcell Jackson, Vanderbilt University
- Investigators
- Gretchen P Jackson, M.D., Ph.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122420
- Sponsor's protocol ID
- 100021
- Status last verified
- Aug 2013
- First submitted
- 10 May 2010
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Resources to Manage Obesity and Health Risks in an Employee Wellness Program
- ClinicalTrials.gov ID
- NCT01122420
- Acronym / sponsor ID
- 100021
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-Setting Tool | Experimental | Other: Goal-Setting Tool |
| Health Web Sites | Active comparator | Other: Health Web Sites |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-Setting ToolAccess to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal | Other | Goal-Setting Tool |
| Health Web SitesAccess to publicly available health-related web sites | Other | Health Web Sites |
Primary outcome
Change in body mass index
Time frame: At enrollment and at 6 months
Change in excess body weight
Time frame: At enrollment and at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gretchen P Jackson, M.D., Ph.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Setting Tool and Health Web Sites in people with Obesity, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body mass index (time frame: At enrollment and at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2013.