Physical ActivityC2P2NCT00577759
Community and Clinician Partnership for Prevention
A study testing Active Intervention and Passive Intervention in people with Physical Activity and Dietary Habits, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Physical Activity, Dietary Habits, Tobacco Use Cessation
- What is being tested?
- Active Intervention and Passive Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Nov 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Internal medicine and family practices in Durham and Orange counties, North Carolina
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27715
About this study
The purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).
Read the detailed description
Tobacco use, poor diet, and lack of physical activity are associated with the leading causes of significant morbidity and mortality, including coronary heart disease, hypertension, cancer, stroke, diabetes, and respiratory dysfunction. One solution to decreasing unhealthy behaviors would be to better integrate primary care providers with community resources, including community and public health organizations that already have the capacity and expertise to deliver effective interventions. This project is a randomized trial to evaluate different practice-level interventions to link practices to community resources to decrease unhealthy behaviors.
- Conditions
- Physical Activity, Dietary Habits, Tobacco Use Cessation
- Being tested
- Active Intervention, Passive Intervention, No intervention
- Keywords
- Quality assurance, health care, primary health care, community health services, referral and consultation, exercise, diet, tobacco
- Medical subject headings
- Motor Activity, Feeding Behavior, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active InterventionOther
Quality improvement activities, including monthly teleconferences and chart audit with feedback, to help practices refer to community resources
Passive InterventionOther
Provision of tools to help with referrals to community resources
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention | Experimental | Direct referral to community organizations, with support for practices to do so. These include the North Carolina Tobacco Quitline, public health department dietitians, and the YMCA. Receives: Other: Active Intervention |
| Passive Intervention | Experimental | Provision of information about community organizations to patients as above. Receives: Other: Passive Intervention |
| Usual Care | Placebo comparator | Usual care Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of referrals from the practices to the community resources
Measured: 6 months
Secondary outcomes (3)
Number of referrals received by each resource
Measured: 6 months
The proportion of patients with unhealthy behaviors who were referred from the practices to community resources
Measured: 6 months
Practice attitudes and practice regarding referral to community resources
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Alex R Kemper, MD, MPH, MS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577759
- Sponsor's protocol ID
- Pro00004061
- Other IDs
- HHSA290200710014
- Acronym
- C2P2
- Status last verified
- Oct 2012
- First submitted
- 13 Dec 2007
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community and Clinician Partnership for Prevention
- ClinicalTrials.gov ID
- NCT00577759
- Acronym / sponsor ID
- C2P2 / Pro00004061
- Conditions
- Physical Activity, Dietary Habits, Tobacco Use Cessation
- Keywords
- Quality assurance, health care, primary health care, community health services, referral and consultation, exercise, diet, tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 20 Dec 2007 (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 purpose of this study is to evaluate the impact of strategies to develop and foster the relationship between primary care practices and community resources to address specific unhealthy behaviors (tobacco use, poor nutrition, and lack of physical activity).
Detailed description
Tobacco use, poor diet, and lack of physical activity are associated with the leading causes of significant morbidity and mortality, including coronary heart disease, hypertension, cancer, stroke, diabetes, and respiratory dysfunction. One solution to decreasing unhealthy behaviors would be to better integrate primary care providers with community resources, including community and public health organizations that already have the capacity and expertise to deliver effective interventions. This project is a randomized trial to evaluate different practice-level interventions to link practices to community resources to decrease unhealthy behaviors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Intervention | Experimental | Other: Active InterventionDirect referral to community organizations, with support for practices to do so. These include the North Carolina Tobacco Quitline, public health department dietitians, and the YMCA. |
| Passive Intervention | Experimental | Other: Passive InterventionProvision of information about community organizations to patients as above. |
| Usual Care | Placebo comparator | Other: No interventionUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Internal medicine and family practices in Durham and Orange counties, North Carolina
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Active InterventionQuality improvement activities, including monthly teleconferences and chart audit with feedback, to help practices refer to community resources | Other | Active Intervention |
| Passive InterventionProvision of tools to help with referrals to community resources | Other | Passive Intervention |
| No interventionNo intervention | Other | Usual Care |
Primary outcome
The number of referrals from the practices to the community resources
Time frame: 6 months
3 secondary outcomes
Number of referrals received by each resource
Time frame: 6 months
The proportion of patients with unhealthy behaviors who were referred from the practices to community resources
Time frame: 6 months
Practice attitudes and practice regarding referral to community resources
Time frame: 6 months
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 16 Feb 2015.
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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.
Alex R Kemper, MD, MPH, MS principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Intervention and Passive Intervention in people with Physical Activity and Dietary Habits, run by Duke University 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 1 inclusion and 1 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 16 Feb 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. Some participants in this study may receive a placebo. 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?
The number of referrals from the practices to the community resources (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2015.