- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00815412
ACTIVATE: Standard Worksite Health Program vs. Activated Consumer (ACTIVATE)
November 25, 2015 updated by: HealthPartners Institute
A 3-year, randomized, controlled trial comparing a traditional worksite health promotion program and an activated consumer program on health practices, health status and patient activation measures.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The design is a cluster, randomized controlled trial of two companies with three arms in each company.
The arms include two control groups (one from each company), two intervention groups using a standard health promotion intervention, and two intervention groups that constitute using an activated consumer intervention.
The standard intervention includes educational offerings to address health behaviors.
The activated consumer intervention offers shorter education sessions and includes decision tools and skills development for working with heath care providers to better manage health and clinical conditions.
Variables include health risk assessments, clinical measures such as lipids, blood pressure, body mass index, and tobacco use, perception of health care consumer practices, claims costs, and absenteeism analysis.
Study Type
Interventional
Enrollment (Actual)
631
Phase
- Not Applicable
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 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Airline and health care employees
Exclusion Criteria:
- Minors
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Counseling in use of health care
|
|
|
Active Comparator: Counseling in diet, exercise
|
|
|
Placebo Comparator: Contol group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Develop and evaluate a worksite-based, activated consumer intervention
Time Frame: March 2005; March 2007
|
March 2005; March 2007
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
September 1, 2004
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
December 29, 2008
First Submitted That Met QC Criteria
December 29, 2008
First Posted (Estimate)
December 30, 2008
Study Record Updates
Last Update Posted (Estimate)
November 26, 2015
Last Update Submitted That Met QC Criteria
November 25, 2015
Last Verified
December 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- R01DP000104-03 (U.S. NIH Grant/Contract)
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.