No Specific Conditions Are Being ExaminedPhase 1NCT00204399
Examining Physician Counseling to Promote Adoption of Physical Activity: A Controlled Trial
A Phase 1 study testing Telephone counseling support in people with No Specific Conditions Are Being Examined, run by University of Saskatchewan.
Trial summary
The purpose of this study is to systematically test the efficacy of two physician-based interventions in changing physical activity patterns of adults over a 20-month period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- No Specific Conditions Are Being Examined
- What is being tested?
- Telephone counseling support
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Dec 2004
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ambulatory adults
Who cannot join
- cardiovascular disease
- respiratory disease
About this study
The purpose of this study is to systematically test the efficacy of two physician-based interventions in changing physical activity patterns of adults over a 20-month period.
Read the detailed description
Although physicians typically counsel for other risk factors of CVD, they are less likely to counsel for increasing levels of physical activity. This is surprising for two reasons: First, physical activity has been identified as an independent modifiable risk factor for CVD. Second, there is a high prevalence of physical inactivity among Canadians. The purpose of the current study is to examine interventions that are designed to promote adoption and maintenance of physical activity through physician recommendations and counseling. The primary outcome measures include possible differences in levels of self-reported physical activity. In addition, several behavioral predictors typically associated with physical activity will be assessed (e.g., self-efficacy, social support, anticipated benefits \& enjoyment, and barriers). There are several unique aspects to this research including: 1) the fact that it compares two types of delivery systems 2) the examination of physical activity patterns over an extended period of time has not been done previously with this type of intervention, and as such, also forms another unique feature of this proposal 3) physician intervention for physical activity has not been done in Canada previously. If the intervention is found effective, the program will add significant value to health services in Saskatchewan and Canada. For instance, the program will enhance the role of physicians in promoting physical activity without increasing the cost of health-care delivery, and with a minimal investment of time required by the physician and his/her staff.
Comparison: To assess the efficacy of the interventions, a quasi experimental design will compare an intervention with a standard control condition. All physicians will be trained to use a standardized protocol to deliver PACE exercise counseling to sedentary patients during one office visit. In the intervention condition, patients will be randomly assigned to receive reminder calls from a research assistant who will provide suggestions as to possible physical activity resources in the community that could be used.
- Being tested
- Telephone counseling support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone counseling supportBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures include possible differences in levels of self-reported physical activity.
Secondary outcomes (1)
In addition, several behavioral predictors typically associated with physical activity will be assessed (e.g., self-efficacy, social support, anticipated benefits & enjoyment, and barriers).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJul 2001
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Specific Conditions Are Being ExaminedStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Kevin S Spink, Ph.D., Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204399
- Sponsor's protocol ID
- HSF2001
- Status last verified
- May 2000
- First submitted
- 12 Sep 2005
- Last updated
- 20 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Physician Counseling to Promote Adoption of Physical Activity: A Controlled Trial
- ClinicalTrials.gov ID
- NCT00204399
- Acronym / sponsor ID
- HSF2001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Jul 2001
- Study completion
- Dec 2004
- First posted
- 20 Sep 2005 (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 systematically test the efficacy of two physician-based interventions in changing physical activity patterns of adults over a 20-month period.
Detailed description
Although physicians typically counsel for other risk factors of CVD, they are less likely to counsel for increasing levels of physical activity. This is surprising for two reasons: First, physical activity has been identified as an independent modifiable risk factor for CVD. Second, there is a high prevalence of physical inactivity among Canadians. The purpose of the current study is to examine interventions that are designed to promote adoption and maintenance of physical activity through physician recommendations and counseling. The primary outcome measures include possible differences in levels of self-reported physical activity. In addition, several behavioral predictors typically associated with physical activity will be assessed (e.g., self-efficacy, social support, anticipated benefits \& enjoyment, and barriers). There are several unique aspects to this research including: 1) the fact that it compares two types of delivery systems 2) the examination of physical activity patterns over an extended period of time has not been done previously with this type of intervention, and as such, also forms another unique feature of this proposal 3) physician intervention for physical activity has not been done in Canada previously. If the intervention is found effective, the program will add significant value to health services in Saskatchewan and Canada. For instance, the program will enhance the role of physicians in promoting physical activity without increasing the cost of health-care delivery, and with a minimal investment of time required by the physician and his/her staff.
Comparison: To assess the efficacy of the interventions, a quasi experimental design will compare an intervention with a standard control condition. All physicians will be trained to use a standardized protocol to deliver PACE exercise counseling to sedentary patients during one office visit. In the intervention condition, patients will be randomly assigned to receive reminder calls from a research assistant who will provide suggestions as to possible physical activity resources in the community that could be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ambulatory adults
Key exclusion criteria (2 listed)
- cardiovascular disease
- respiratory disease
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 |
|---|---|---|
| Telephone counseling support | Behavioural | – |
Primary outcome
The primary outcome measures include possible differences in levels of self-reported physical activity.
1 secondary outcome
In addition, several behavioral predictors typically associated with physical activity will be assessed (e.g., self-efficacy, social support, anticipated benefits & enjoyment, and barriers).
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 20 Sep 2005.
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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.
Kevin S Spink, Ph.D. principal investigator
University of Saskatchewan
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telephone counseling support in people with No Specific Conditions Are Being Examined, run by University of Saskatchewan.
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 2 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 20 Sep 2005. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome measures include possible differences in levels of self-reported physical activity.. 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 20 Sep 2005.