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The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team (PAC)

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ClinicalTrials.gov Identifier: NCT00222560
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : April 30, 2007
Sponsor:
Collaborator:
Hopital Montfort
Information provided by:
University of Ottawa

Tracking Information
First Submitted Date  ICMJE September 16, 2005
First Posted Date  ICMJE September 22, 2005
Last Update Posted Date April 30, 2007
Study Start Date  ICMJE May 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
  • Motivation to change physical activity behaviour
  • Confidence to change physical activity behaviour
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2005)
  • Quality of life
  • Percieved competence
  • Processes of change
  • Physical activity (self-report and objective)
  • Fitness and metabolic measures
  • Cost consequences
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team
Official Title  ICMJE The PAC Project: Integrating a Physical Activity Counsellor in the Primary Health Care Team: A Randomized Controlled Trial
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Physical Inactivity
Intervention  ICMJE Behavioral: Intensive physical activity counselling by an integrated physical activity counsellor
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2007)
120
Original Enrollment  ICMJE
 (submitted: September 16, 2005)
150
Actual Study Completion Date  ICMJE June 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00222560
Other Study ID Numbers  ICMJE G03-05441
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of Ottawa
Collaborators  ICMJE Hopital Montfort
Investigators  ICMJE
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
PRS Account University of Ottawa
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP