Physical InactivityPhase 2PACNCT00222560
The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team
A Phase 2 study testing Intensive physical activity counselling by an integrated physical activity counsellor in people with Physical Inactivity, run by University of Ottawa at 1 site in Canada.
Trial summary
The Physical Activity Counselling (PAC) randomized controlled trial had as overall goal the establishment of a collaborative interdisciplinary primary care team to encourage physical activity. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Physical Inactivity
- What is being tested?
- Intensive physical activity counselling by an integrated physical activity counsellor
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Jun 2006
- Phase
- Phase 2
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 to 69 years
- <150 minutes of physical activity/week
- no uncontrolled medical conditions
Who cannot join
- pregnancy (funder's request),
- planned absence >3 weeks during the first 3 months of the study,
- living with another patient in the study,
- uncontrolled medical condition,
- did not receive a physical activity prescription from their provider during the brief physical activity counselling,
- received brief counselling more than once during the trial period and
- uninterested in receiving intensive physical activity counselling
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team: A Randomized Controlled Trial
The Physical Activity Counselling (PAC) randomized controlled trial had as overall goal the establishment of a collaborative interdisciplinary primary care team to encourage physical activity. The main intervention was to integrate a physical activity counsellor to the primary care team so that the most appropriate care was given by the most appropriate provider. Much research has shown and many experts agree that patients need significant help to make and especially maintain physical activity behavior changes. Maintenance of these changes is essential for optimal health benefits. It was predicted that patients receiving both brief (2-4 minute) physical activity counselling from their family physician and intensive (3 month) physical activity counselling from an integrated physical activity counsellor (intensive counselling group) would report greater improvements in task motivation and task self-efficacy to engage in physical activity at the end of the intervention than those receiving only brief counselling (brief counselling group). The same was expected for both self-reported and objective physical activity. This RCT involved testing a theory-based counselling intervention, determining why the intervention was effective or ineffective by measuring key psychological mediating variables, using an objective measure to track changes in physical activity, and assessing physical and metabolic outcomes. This project represents an innovative theoretically based multi-level multi-intervention approach to promoting physical activity in primary care and is of great public health importance.
Read the detailed description
Family doctors and nurses (health care providers - HCP) recommend that their patients are physically active because this is one of the most important things that patients can do to benefit their health. The Physical Activity Counselling (PAC) randomized controlled trial examined what happens when a physical activity counsellor is added to the family health care team. For the project, HCPs did a brief, 2-4 minute counselling session with their patients who reported doing less than 150 minutes of physical activity a week. Half (59) of the patients in the PAC Project only received this brief counselling from their HCP (brief counselling group) while the other half (61) also received six sessions with the physical activity counsellor over a three month period (intensive counselling group). The purpose of the project was to compare these 2 groups. The HCPs and the PAC used the 7 As shared-care model for physical activity counselling in primary care (Fortier et al., 2006). The HCPs and the PAC tried to help the patients want to (be motivated to) and to feel able to (be confident that they can) increase their level of physical activity. A number of validated questionnaires as well as some interviews were used to look at the effects of the counselling on motivation, confidence and physical activity. As well patients wore wear a small gadget known as an accelerometer to measure their actual physical activity. Quality of life was measured in all patients. Some patients (one third) had physical and metabolic testing three times during the trial. The cost of adding a PAC to a family health care team was also assessed.
- Conditions
- Physical Inactivity
- Being tested
- Intensive physical activity counselling by an integrated physical activity counsellor
- Keywords
- physical activity counselling, physical activity behavior change intervention, prevention, collaborative health care, physical inactivity, motivation, fitness, randomized controlled trial
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive physical activity counselling by an integrated physical activity counsellorBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
task motivation to engage in physical activity (0-100% motivated to engage in physical activity from 1-7 days a week in the next 6 weeks)
Measured: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
task self-efficacy to engage in physical activity (0-100% confident to engage in physical activity from 1-7 days a week in the next 6 weeks), measured every 6 weeks up to 25 weeks for maintenance
Measured: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
Secondary outcomes (4)
Physical activity (subjective: in units with the Godin Leisure-Time Exercise Questionnaire)
Measured: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
physical activity (objective: in activity counts by the Actical accelerometer)
Measured: baseline, 13 weeks, 25 weeks
Quality of life
Measured: baseline, 13 weeks, 25 weeks
Physical and metabolic outcomes (33% sample)
Measured: baseline, 13 weeks, 25 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical InactivityStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ottawa
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Montfort
- Investigators
- Michelle Fortier, PhD, Principal investigator, University of Ottawa, Faculty of Health SciencesWilliam Hogg, MD, Principal investigator, Department of Family Medicine, University of Ottawa and the C.T. Lamont Primary Health Care Research Centre, Élisabeth Bruyère Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222560
- Sponsor's protocol ID
- G03-05441
- Acronym
- PAC
- Status last verified
- Apr 2007
- First submitted
- 16 Sep 2005
- Last updated
- 30 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Fortier M, Tulloch H, Hogg W. A good fit: integrating physical activity counselors into family practice. Can Fam Physician. 2006 Aug;52(8):942-4, 947-9. No abstract available.
PubMed 17273491Tulloch H, Fortier M, Hogg W. Physical activity counseling in primary care: who has and who should be counseling? Patient Educ Couns. 2006 Dec;64(1-3):6-20. doi: 10.1016/j.pec.2005.10.010. Epub 2006 Feb 10.
PubMed 16472959
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00222560
- Acronym / sponsor ID
- PAC / G03-05441
- Conditions
- Physical Inactivity
- Keywords
- physical activity counselling, physical activity behavior change intervention, prevention, collaborative health care, physical inactivity, motivation, fitness, randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of OttawaUniversity, hospital or other
- Collaborators
- Hopital Montfort
- Study start
- May 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 22 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 Physical Activity Counselling (PAC) randomized controlled trial had as overall goal the establishment of a collaborative interdisciplinary primary care team to encourage physical activity. The main intervention was to integrate a physical activity counsellor to the primary care team so that the most appropriate care was given by the most appropriate provider. Much research has shown and many experts agree that patients need significant help to make and especially maintain physical activity behavior changes. Maintenance of these changes is essential for optimal health benefits. It was predicted that patients receiving both brief (2-4 minute) physical activity counselling from their family physician and intensive (3 month) physical activity counselling from an integrated physical activity counsellor (intensive counselling group) would report greater improvements in task motivation and task self-efficacy to engage in physical activity at the end of the intervention than those receiving only brief counselling (brief counselling group). The same was expected for both self-reported and objective physical activity. This RCT involved testing a theory-based counselling intervention, determining why the intervention was effective or ineffective by measuring key psychological mediating variables, using an objective measure to track changes in physical activity, and assessing physical and metabolic outcomes. This project represents an innovative theoretically based multi-level multi-intervention approach to promoting physical activity in primary care and is of great public health importance.
Detailed description
Family doctors and nurses (health care providers - HCP) recommend that their patients are physically active because this is one of the most important things that patients can do to benefit their health. The Physical Activity Counselling (PAC) randomized controlled trial examined what happens when a physical activity counsellor is added to the family health care team. For the project, HCPs did a brief, 2-4 minute counselling session with their patients who reported doing less than 150 minutes of physical activity a week. Half (59) of the patients in the PAC Project only received this brief counselling from their HCP (brief counselling group) while the other half (61) also received six sessions with the physical activity counsellor over a three month period (intensive counselling group). The purpose of the project was to compare these 2 groups. The HCPs and the PAC used the 7 As shared-care model for physical activity counselling in primary care (Fortier et al., 2006). The HCPs and the PAC tried to help the patients want to (be motivated to) and to feel able to (be confident that they can) increase their level of physical activity. A number of validated questionnaires as well as some interviews were used to look at the effects of the counselling on motivation, confidence and physical activity. As well patients wore wear a small gadget known as an accelerometer to measure their actual physical activity. Quality of life was measured in all patients. Some patients (one third) had physical and metabolic testing three times during the trial. The cost of adding a PAC to a family health care team was also assessed.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 to 69 years
- <150 minutes of physical activity/week
- no uncontrolled medical conditions
Key exclusion criteria (7 listed)
- pregnancy (funder's request),
- planned absence >3 weeks during the first 3 months of the study,
- living with another patient in the study,
- uncontrolled medical condition,
- did not receive a physical activity prescription from their provider during the brief physical activity counselling,
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 |
|---|---|---|
| Intensive physical activity counselling by an integrated physical activity counsellor | Behavioural | – |
Primary outcome
task motivation to engage in physical activity (0-100% motivated to engage in physical activity from 1-7 days a week in the next 6 weeks)
Time frame: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
task self-efficacy to engage in physical activity (0-100% confident to engage in physical activity from 1-7 days a week in the next 6 weeks), measured every 6 weeks up to 25 weeks for maintenance
Time frame: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
4 secondary outcomes
Physical activity (subjective: in units with the Godin Leisure-Time Exercise Questionnaire)
Time frame: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
physical activity (objective: in activity counts by the Actical accelerometer)
Time frame: baseline, 13 weeks, 25 weeks
Quality of life
Time frame: baseline, 13 weeks, 25 weeks
Physical and metabolic outcomes (33% sample)
Time frame: baseline, 13 weeks, 25 weeks
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 30 Apr 2007.
- Background: PubMed 17273491Fortier M, Tulloch H, Hogg W. A good fit: integrating physical activity counselors into family practice. Can Fam Physician. 2006 Aug;52(8):942-4, 947-9. No abstract available.
- Background: PubMed 16472959Tulloch H, Fortier M, Hogg W. Physical activity counseling in primary care: who has and who should be counseling? Patient Educ Couns. 2006 Dec;64(1-3):6-20. doi: 10.1016/j.pec.2005.10.010. Epub 2006 Feb 10.
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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.
Michelle Fortier, PhD principal investigator
University of Ottawa, Faculty of Health Sciences
William Hogg, MD principal investigator
Department of Family Medicine, University of Ottawa and the C.T. Lamont Primary Health Care Research Centre, Élisabeth Bruyère Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intensive physical activity counselling by an integrated physical activity counsellor in people with Physical Inactivity, run by University of Ottawa at 1 site in Canada.
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 3 inclusion and 7 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 30 Apr 2007. 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 Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
task motivation to engage in physical activity (0-100% motivated to engage in physical activity from 1-7 days a week in the next 6 weeks) (time frame: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00222560, which also lists 2 linked publications.
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 30 Apr 2007.