Evidence of Improved Health StatusACTIVATENCT00815412
ACTIVATE: Standard Worksite Health Program vs. Activated Consumer
A study testing Counseling in use of health care and Counseling in diet, exercise in people with Evidence of Improved Health Status, run by HealthPartners Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Evidence of Improved Health Status
- What is being tested?
- Counseling in use of health care and Counseling in diet, exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 631 participants
- Where
- No sites listed yet
- Study dates
- Sep 2004to Sep 2008
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Airline and health care employees
Who cannot join
- Minors
About this study
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.
Read the 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.
- Conditions
- Evidence of Improved Health Status
- Being tested
- Counseling in use of health care, Counseling in diet, exercise, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling in use of health careBehavioural
Counseling in diet, exerciseBehavioural
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Counseling in use of health care | Active comparator | Not described Receives: Behavioral: Counseling in use of health care |
| Counseling in diet, exercise | Active comparator | Not described Receives: Behavioral: Counseling in diet, exercise |
| Contol group | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop and evaluate a worksite-based, activated consumer intervention
Measured: March 2005; March 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startSep 2004
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Improved Health StatusStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815412
- Sponsor's protocol ID
- R01DP000104-03
- Acronym
- ACTIVATE
- Status last verified
- Dec 2008
- First submitted
- 29 Dec 2008
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTIVATE: Standard Worksite Health Program vs. Activated Consumer
- ClinicalTrials.gov ID
- NCT00815412
- Acronym / sponsor ID
- ACTIVATE / R01DP000104-03
- Conditions
- Evidence of Improved Health Status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Sep 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 30 Dec 2008 (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.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counseling in use of health care | Active comparator | Behavioral: Counseling in use of health care |
| Counseling in diet, exercise | Active comparator | Behavioral: Counseling in diet, exercise |
| Contol group | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Airline and health care employees
Key exclusion criteria (1 listed)
- Minors
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 |
|---|---|---|
| Counseling in use of health care | Behavioural | Counseling in use of health care |
| Counseling in diet, exercise | Behavioural | Counseling in diet, exercise |
| Control | Other | Contol group |
Primary outcome
Develop and evaluate a worksite-based, activated consumer intervention
Time frame: March 2005; March 2007
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 26 Nov 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in use of health care and Counseling in diet, exercise in people with Evidence of Improved Health Status, run by HealthPartners Institute.
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 1 inclusion and 1 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 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Develop and evaluate a worksite-based, activated consumer intervention (time frame: March 2005; March 2007). 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 26 Nov 2015.