- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00222560
The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team (PAC)
April 27, 2007 updated by: University of Ottawa
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1K 0T1
- Montfort Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged 18 to 69 years
- <150 minutes of physical activity/week
- no uncontrolled medical conditions
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
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
|
baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Physical activity (subjective: in units with the Godin Leisure-Time Exercise Questionnaire)
Time Frame: baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks
|
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
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baseline, 13 weeks, 25 weeks
|
|
Quality of life
Time Frame: baseline, 13 weeks, 25 weeks
|
baseline, 13 weeks, 25 weeks
|
|
Physical and metabolic outcomes (33% sample)
Time Frame: baseline, 13 weeks, 25 weeks
|
baseline, 13 weeks, 25 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Fortier, PhD, University of Ottawa, Faculty of Health Sciences
- Principal Investigator: William Hogg, MD, Department of Family Medicine, University of Ottawa and the C.T. Lamont Primary Health Care Research Centre, Élisabeth Bruyère Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tulloch 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
September 16, 2005
First Submitted That Met QC Criteria
September 16, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
April 30, 2007
Last Update Submitted That Met QC Criteria
April 27, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- G03-05441
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.