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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Telephone counseling support
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.

  1. The primary outcome measures include possible differences in levels of self-reported physical activity.

Secondary outcomes (1)
  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.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJul 2001
  3. Study completionDec 2004

Resources

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
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

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.

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