HealthyNCT00924924
Act Healthy! A Controlled Trial of Worksite Health Promotion
A study testing Act Healthy! in people with Healthy, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The purpose of this project is to determine if a worksite wellness intervention using a theoretically-based self-management model increases confidence for carrying out healthy behaviors and improves health practices of participating employees. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Act Healthy!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- full-time employee of the University of Missouri
Who cannot join
- inability to read and speak in English
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this project is to determine if a worksite wellness intervention using a theoretically-based self-management model increases confidence for carrying out healthy behaviors and improves health practices of participating employees. The research questions are: 1) does the intervention produce between group differences in behavior self-efficacy and actual health behaviors, 2) are self-efficacy and performance of health behaviors related, and 3) do changes in self-efficacy result in changes in behavior.
Read the detailed description
The purpose of this project is to see if a six-week education program called Act Healthy! led by trained volunteers from the UM T.E. Atkins Wellness Program is able to help people who take the classes improve their confidence in their ability to choose good health behaviors and carry out new behaviors. The project will use the Stanford University Self-management education model and train volunteers to be teachers. People who work on the MU campus will be recruited to take a 50-minute class once a week for six weeks. Class members will complete questionnaires before and after the class and again three months later that ask about their health behaviors and confidence to perform health behaviors. This information will be analyzed to determine if the classes were effective in helping people act in healthier ways.
- Conditions
- Healthy
- Being tested
- Act Healthy!, Delayed treatment control
- Keywords
- health promotion, prevention, worksite wellness, behavior change, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Act Healthy!Behavioural
Also called self-management, health promotion, worksite wellness, behavior change
Six-week class of 50 minute sessions of self-management training for health behaviors
Delayed treatment controlBehavioural
Delayed self-management training group - begins following completion of the experimental group training
| Study group | Role | What they receive |
|---|---|---|
| Act Healthy! | Experimental | Immediate treatment group of six-weeks of classes in self-management training for healthy behaviors Receives: Behavioral: Act Healthy! |
| Delayed treatment control | Active comparator | Delayed self-management training group - begins following completion of the experimental group training Receives: Behavioral: Act Healthy!; Behavioral: Delayed treatment control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report of health behaviors
Measured: pre-, post intervention; 3-month follow up
Secondary outcomes (2)
self-efficacy for health behaviors
Measured: pre- and post-intervention; 3-month follow up
Stages of change scale
Measured: pre- and post-intervention; 3-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marian A Minor, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924924
- Sponsor's protocol ID
- 1141037
- Status last verified
- Oct 2016
- First submitted
- 18 Jun 2009
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Act Healthy! A Controlled Trial of Worksite Health Promotion
- ClinicalTrials.gov ID
- NCT00924924
- Acronym / sponsor ID
- 1141037
- Conditions
- Healthy
- Keywords
- health promotion, prevention, worksite wellness, behavior change, healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 19 Jun 2009 (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 project is to determine if a worksite wellness intervention using a theoretically-based self-management model increases confidence for carrying out healthy behaviors and improves health practices of participating employees. The research questions are: 1) does the intervention produce between group differences in behavior self-efficacy and actual health behaviors, 2) are self-efficacy and performance of health behaviors related, and 3) do changes in self-efficacy result in changes in behavior.
Detailed description
The purpose of this project is to see if a six-week education program called Act Healthy! led by trained volunteers from the UM T.E. Atkins Wellness Program is able to help people who take the classes improve their confidence in their ability to choose good health behaviors and carry out new behaviors. The project will use the Stanford University Self-management education model and train volunteers to be teachers. People who work on the MU campus will be recruited to take a 50-minute class once a week for six weeks. Class members will complete questionnaires before and after the class and again three months later that ask about their health behaviors and confidence to perform health behaviors. This information will be analyzed to determine if the classes were effective in helping people act in healthier ways.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Act Healthy! | Experimental | Behavioral: Act Healthy!Immediate treatment group of six-weeks of classes in self-management training for healthy behaviors |
| Delayed treatment control | Active comparator | Behavioral: Act Healthy!, Behavioral: Delayed treatment controlDelayed self-management training group - begins following completion of the experimental group training |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- full-time employee of the University of Missouri
Key exclusion criteria (1 listed)
- inability to read and speak in English
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 |
|---|---|---|
| Act Healthy!Also: self-management, health promotion, worksite wellness, behavior changeSix-week class of 50 minute sessions of self-management training for health behaviors | Behavioural | Act Healthy!, Delayed treatment control |
| Delayed treatment controlDelayed self-management training group - begins following completion of the experimental group training | Behavioural | Delayed treatment control |
Primary outcome
Self-report of health behaviors
Time frame: pre-, post intervention; 3-month follow up
2 secondary outcomes
self-efficacy for health behaviors
Time frame: pre- and post-intervention; 3-month follow up
Stages of change scale
Time frame: pre- and post-intervention; 3-month follow up
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 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Marian A Minor, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Act Healthy! in people with Healthy, run by University of Missouri-Columbia 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 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 5 Oct 2016. 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?
Self-report of health behaviors (time frame: pre-, post intervention; 3-month follow up). 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 5 Oct 2016.