Communication Intervention Physical Activity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01419093
Recruitment Status : Completed
First Posted : August 17, 2011
Last Update Posted : September 18, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Rochester

Brief Summary:
The project is a two-arm randomized clinical trial to pilot the feasibility of a communication training intervention for primary care clinicians, linked to a community program referral, on use of the 5As to promote physical activity in underserved patients.

Condition or disease Intervention/treatment Phase
Physical Activity Other: 5 A communication intervention Not Applicable

Detailed Description:
This study will focus on training clinicians to communicate effectively using the 5As and patient-centered communication skills (Aim 1). When implemented fully, the intervention will also include referral to a community fitness program. Clinicians will be randomly assigned to two groups (1 and 2). Group 1 will participate in the training intervention first; group 2 will act as a wait-list control for Group 1. The primary outcome, the effectiveness of the intervention on clinician use of the 5As during routine office visits, will be measured by examining 371 audio-recorded patient visits prior to, immediately, after, and 6 months after the clinician is trained. Secondary outcomes include whether the communication training intervention improved patients' perceived competence to adopt physical activity (Aim 2)and whether clinicians believe that the communication intervention addressed pertinent barriers to promoting exercise (Aim 3). Exploratory outcomes (Aim 4) will [assess potential mediators of the intervention's effect, examine the effect of the intervention on actual physical activity levels in a subset of participants, and create a taxonomy of communication markers for each of the 5As.]

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Communication Intervention for Physical Activity in Underserved Communities
Study Start Date : September 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: 5A Communication
Behavioral: 5 A intervention for physical activity
Other: 5 A communication intervention
This study will examine the effect of primary care clinicians' communication intervention linked to a community-based exercise program. We will use the 5As in discussion of physical activity in 371 office visits in an ethnically diverse, primarily low income patient population. Secondary and exploratory aims are to provide pilot information on [feasibility and sustainability of the intervention from the patients' and clinicians' perspective and derive effect sizes on the intervention's effect on objective changes in physical activity in a subset of participants.
Other Name: ethnically diverse physical activity clinician communication

Primary Outcome Measures :
  1. Number of A's used per visit per discussion of physical activity [ Time Frame: 5 years ]
    The mean 5A Score of patients from clinicians who complete the communicatin interventon will be higher thant the mean 5A Score of patients from physicisns that have not been trained. Analytic plan: Unadjusted analysis will use two-sample t-tests to compare means. Adjusted analyses will use linear mixed effects models as described in the Statistical Analysis section.

Secondary Outcome Measures :
  1. Patient-centered Communication Constructs [ Time Frame: 5 years ]
    Patient survey; fifteen items.Assesses patient perceptions of providers' being autonomy supportive versus controlling. Measures participants' feelings of competence at carrying out a treament regimen. Scored by trained coder listening to audiorecorded visits. Clinicians survey; 20 items such as whether the clinician would recmmend the intervention to other clinicians.

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Current patients at Westside Health Services
  • Be scheduled for a routine, follow-up or health maintenance office visit
  • Be practicing clinicians (physicians, physician asst. or nurse practitioner

Exclusion Criteria:

  • Have life-threatening acute medical problem which precludes participation
  • Unable to read and understand English
  • Already achieving recommended level of physical activity
  • Planning to move or relocate (clinicians) to another practice in the study period
  • Serving as study investigators, consultants, or advisors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01419093

United States, New York
Westside Health Services
Rochester, New York, United States, 14608
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
Principal Investigator: Jennifer Carroll, MD, MPH University of Rochester