Physical Inactivity Clinical Trial
— PACOfficial title:
The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team: A Randomized Controlled Trial
Verified date | April 2007 |
Source | University of Ottawa |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ministry of Health & Long Term Care, Ontario |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 69 Years |
Eligibility |
Inclusion Criteria: 1. aged 18 to 69 years 2. <150 minutes of physical activity/week 3. no uncontrolled medical conditions Exclusion Criteria: 1. pregnancy (funder’s request), 2. planned absence >3 weeks during the first 3 months of the study, 3. living with another patient in the study, 4. uncontrolled medical condition, 5. did not receive a physical activity prescription from their provider during the brief physical activity counselling, 6. received brief counselling more than once during the trial period and 7. uninterested in receiving intensive physical activity counselling |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | Montfort Hospital | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Ottawa | Hopital Montfort |
Canada,
Fortier M, Tulloch H, Hogg W. A good fit: integrating physical activity counselors into family practice. Can Fam Physician. 2006 Aug;52:942-4, 947-9. English, French. — View Citation
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. Epub 2006 Feb 10. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks | ||
Primary | 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 | baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks | ||
Secondary | Physical activity (subjective: in units with the Godin Leisure-Time Exercise Questionnaire) | baseline, 6 weeks, 13 weeks, 19 weeks, 25 weeks | ||
Secondary | physical activity (objective: in activity counts by the Actical accelerometer) | baseline, 13 weeks, 25 weeks | ||
Secondary | Quality of life | baseline, 13 weeks, 25 weeks | ||
Secondary | Physical and metabolic outcomes (33% sample) | baseline, 13 weeks, 25 weeks |
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