Physical ActivityNCT01419093
Communication Intervention Physical Activity
A study testing 5 A communication intervention in people with Physical Activity, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- 5 A communication intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2013
- Phase
- Interventional
- 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 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Communication Intervention for Physical Activity in Underserved Communities
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.
Read the 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.]
- Conditions
- Physical Activity
- Being tested
- 5 A communication intervention
- Keywords
- Physical Activity, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 A communication interventionOther
Also called ethnically diverse physical activity clinician communication
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.
| Study group | Role | What they receive |
|---|---|---|
| 5A Communication | No intervention | Behavioral: 5 A intervention for physical activity Receives: Other: 5 A communication intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of A's used per visit per discussion of physical activity
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.
Measured: 5 years
Secondary outcomes (1)
Patient-centered Communication Constructs
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startSep 2008
- Primary completionDec 2013
- Study completionDec 2013
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 ActivityStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer Carroll, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419093
- Sponsor's protocol ID
- 5K07CA126985
- Other IDs
- 5K07CA126985
- Status last verified
- Sep 2015
- First submitted
- 10 Aug 2011
- Last updated
- 18 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Carroll JK, Winters PC, Sanders MR, Decker F, Ngo T, Sciamanna CN. Clinician-targeted intervention and patient-reported counseling on physical activity. Prev Chronic Dis. 2014 May 29;11:E89. doi: 10.5888/pcd11.130302.
PubMed 24874781Carroll JK, Fiscella K, Epstein RM, Sanders MR, Winters PC, Moorhead SA, van Osch L, Williams GC. Physical activity counseling intervention at a federally qualified health center: improves autonomy-supportiveness, but not patients' perceived competence. Patient Educ Couns. 2013 Sep;92(3):432-6. doi: 10.1016/j.pec.2013.06.031. Epub 2013 Aug 7.
PubMed 23932756
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Communication Intervention for Physical Activity in Underserved Communities
- ClinicalTrials.gov ID
- NCT01419093
- Acronym / sponsor ID
- 5K07CA126985
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Aug 2011 (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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5A Communication | No intervention | Other: 5 A communication interventionBehavioral: 5 A intervention for physical activity |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| 5 A communication interventionAlso: ethnically diverse physical activity clinician communicationThis 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 | 5A Communication |
Primary outcome
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.
1 secondary outcome
Patient-centered Communication Constructs
Time frame: 5 years
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 18 Sep 2015.
- Derived from this study: PubMed 24874781Carroll JK, Winters PC, Sanders MR, Decker F, Ngo T, Sciamanna CN. Clinician-targeted intervention and patient-reported counseling on physical activity. Prev Chronic Dis. 2014 May 29;11:E89. doi: 10.5888/pcd11.130302.
- Derived from this study: PubMed 23932756Carroll JK, Fiscella K, Epstein RM, Sanders MR, Winters PC, Moorhead SA, van Osch L, Williams GC. Physical activity counseling intervention at a federally qualified health center: improves autonomy-supportiveness, but not patients' perceived competence. Patient Educ Couns. 2013 Sep;92(3):432-6. doi: 10.1016/j.pec.2013.06.031. Epub 2013 Aug 7.
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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.
Jennifer Carroll, MD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 A communication intervention in people with Physical Activity, run by University of Rochester at 1 site in United States.
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 5 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 18 Sep 2015. 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 United States. 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.
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?
Number of A's used per visit per discussion of physical activity (time frame: 5 years). 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 NCT01419093, 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 18 Sep 2015.