Unhealthy Diet, Exercise, Smoking, and Alcohol UseNCT00292968
A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
A study testing Computer based care, Telephone counseling and Group visits in people with Unhealthy Diet, Exercise, Smoking, and Alcohol Use, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Using an electronic health record to link the resources of primary care practices and community programs will help patients to improve their diet and exercise, quit smoking, and moderate their drinking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unhealthy Diet, Exercise, Smoking, and Alcohol Use
- What is being tested?
- Computer based care, Telephone counseling and Group visits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,670 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Aug 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All individuals over the age of 8 years presenting for care in 9 primary care practices
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Riverside Physicians Associates
Newport News, Virginia, 23666
About this study
Using an electronic health record to link the resources of primary care practices and community programs will help patients to improve their diet and exercise, quit smoking, and moderate their drinking.
Read the detailed description
We posit that practice systems to promote healthy behaviors must combine five attributes to be effective and sustainable. They must be comprehensive (addressing multiple behaviors and the "5 As"), flexible (offering options), generalizable to ordinary practices, practice-friendly (limiting burden), and apply the Chronic Care Model. We will test the effectiveness and implementation of an innovative "packaged" intervention with these features. Six ACORN-affiliated practices will adopt a brief (3 minute) routine to deliver A1-3 (Ask, Advise, Agree) in the office and to offer patients four options for intensive assistance (Assist [A4], Arrange [A5]) outside the office. Patients can select 9 months of online, telephone, or group counseling; or usual care. An electronic health record (EHR) will expedite the in-office intervention and referrals. Outcome measures will include health behaviors (derived from 7200 surveys administered pre-intervention and 3 and 9 months post-exposure) and implementation (derived from EHR data, "counselee" surveys, and patient/staff interviews). We hypothesize that implementing this novel "package" of interventions will be associated with improved health behaviors (using the Common Measures for physical activity, diet, smoking, and alcohol use). EHR-captured data will measure RE-AIM parameters, including Reach (14 sub-measures), Adoption, and Maintenance. Surveys and qualitative analysis of semi-structured interviews with patients and office staff will explore Implementation issues and suggested improvements. We hope to demonstrate that this innovative intervention not only promotes healthy behaviors but is feasible and sustainable in primary care. Accomplishing these goals requires a delicate balancing act--deploying evidence-based strategies that are effective in lifestyle change but limit demands for new staff, training, or time. We strike this balance by harnessing effective technologies and tools and by leveraging resources outside the practice. If our intervention helps patients change unhealthy behaviors and is appealing to ordinary practices, we envision the potential for widespread adoption and substantial population health benefits.
- Being tested
- Computer based care, Telephone counseling, Group visits, Usual care
- Keywords
- Health Behavior, Prevention, Informatics, Electronic Health Record
- Medical subject headings
- Motor Activity, Smoking, Alcohol Drinking, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer based careBehavioural
Telephone counselingBehavioural
Group visitsBehavioural
Usual careBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Health behaviors (diet, exercise, smoking status, and alcohol use
Measured: 4 and 9 months post intervention
Secondary outcomes (1)
Intervention's Reach, Adoption, Implementation, Maintenance
Measured: At the time of delivery of care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Unhealthy Diet, Exercise, Smoking, and Alcohol UseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Alex Krist, MD, Study director, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292968
- Sponsor's protocol ID
- 6268
- Status last verified
- Jul 2012
- First submitted
- 15 Feb 2006
- Last updated
- 20 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Krist AH, Cifuentes M, Dodoo MS, Green LA. Measuring primary care expenses. J Am Board Fam Med. 2010 May-Jun;23(3):376-83. doi: 10.3122/jabfm.2010.03.090089.
PubMed 20453184Wilson DB, Johnson RE, Jones RM, Krist AH, Woolf SH, Flores SK. Patient weight counseling choices and outcomes following a primary care and community collaborative intervention. Patient Educ Couns. 2010 Jun;79(3):338-43. doi: 10.1016/j.pec.2010.01.025. Epub 2010 Mar 24.
PubMed 20338714Krist AH, Woolf SH, Johnson RE, Rothemich SF, Cunningham TD, Jones RM, Wilson DB, Devers KJ. Patient costs as a barrier to intensive health behavior counseling. Am J Prev Med. 2010 Mar;38(3):344-8. doi: 10.1016/j.amepre.2009.11.010.
PubMed 20171538Dodoo MS, Krist AH, Cifuentes M, Green LA. Start-up and incremental practice expenses for behavior change interventions in primary care. Am J Prev Med. 2008 Nov;35(5 Suppl):S423-30. doi: 10.1016/j.amepre.2008.08.007.
PubMed 18929990Krist AH, Woolf SH, Frazier CO, Johnson RE, Rothemich SF, Wilson DB, Devers KJ, Kerns JW. An electronic linkage system for health behavior counseling effect on delivery of the 5A's. Am J Prev Med. 2008 Nov;35(5 Suppl):S350-8. doi: 10.1016/j.amepre.2008.08.010.
PubMed 18929981
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Practice-Friendly Model for Promoting Healthy Behaviors
- ClinicalTrials.gov ID
- NCT00292968
- Acronym / sponsor ID
- 6268
- Keywords
- Health Behavior, Prevention, Informatics, Electronic Health Record
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,670 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jun 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 16 Feb 2006 (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.
Using an electronic health record to link the resources of primary care practices and community programs will help patients to improve their diet and exercise, quit smoking, and moderate their drinking.
Detailed description
We posit that practice systems to promote healthy behaviors must combine five attributes to be effective and sustainable. They must be comprehensive (addressing multiple behaviors and the "5 As"), flexible (offering options), generalizable to ordinary practices, practice-friendly (limiting burden), and apply the Chronic Care Model. We will test the effectiveness and implementation of an innovative "packaged" intervention with these features. Six ACORN-affiliated practices will adopt a brief (3 minute) routine to deliver A1-3 (Ask, Advise, Agree) in the office and to offer patients four options for intensive assistance (Assist [A4], Arrange [A5]) outside the office. Patients can select 9 months of online, telephone, or group counseling; or usual care. An electronic health record (EHR) will expedite the in-office intervention and referrals. Outcome measures will include health behaviors (derived from 7200 surveys administered pre-intervention and 3 and 9 months post-exposure) and implementation (derived from EHR data, "counselee" surveys, and patient/staff interviews). We hypothesize that implementing this novel "package" of interventions will be associated with improved health behaviors (using the Common Measures for physical activity, diet, smoking, and alcohol use). EHR-captured data will measure RE-AIM parameters, including Reach (14 sub-measures), Adoption, and Maintenance. Surveys and qualitative analysis of semi-structured interviews with patients and office staff will explore Implementation issues and suggested improvements. We hope to demonstrate that this innovative intervention not only promotes healthy behaviors but is feasible and sustainable in primary care. Accomplishing these goals requires a delicate balancing act--deploying evidence-based strategies that are effective in lifestyle change but limit demands for new staff, training, or time. We strike this balance by harnessing effective technologies and tools and by leveraging resources outside the practice. If our intervention helps patients change unhealthy behaviors and is appealing to ordinary practices, we envision the potential for widespread adoption and substantial population health benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals over the age of 8 years presenting for care in 9 primary care practices
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 |
|---|---|---|
| Computer based care | Behavioural | – |
| Telephone counseling | Behavioural | – |
| Group visits | Behavioural | – |
| Usual care | Behavioural | – |
Primary outcome
Health behaviors (diet, exercise, smoking status, and alcohol use
Time frame: 4 and 9 months post intervention
1 secondary outcome
Intervention's Reach, Adoption, Implementation, Maintenance
Time frame: At the time of delivery of care
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 20 Jul 2012.
- Background: PubMed 20453184Krist AH, Cifuentes M, Dodoo MS, Green LA. Measuring primary care expenses. J Am Board Fam Med. 2010 May-Jun;23(3):376-83. doi: 10.3122/jabfm.2010.03.090089.
- Results publication: PubMed 20338714Wilson DB, Johnson RE, Jones RM, Krist AH, Woolf SH, Flores SK. Patient weight counseling choices and outcomes following a primary care and community collaborative intervention. Patient Educ Couns. 2010 Jun;79(3):338-43. doi: 10.1016/j.pec.2010.01.025. Epub 2010 Mar 24.
- Results publication: PubMed 20171538Krist AH, Woolf SH, Johnson RE, Rothemich SF, Cunningham TD, Jones RM, Wilson DB, Devers KJ. Patient costs as a barrier to intensive health behavior counseling. Am J Prev Med. 2010 Mar;38(3):344-8. doi: 10.1016/j.amepre.2009.11.010.
- Results publication: PubMed 18929990Dodoo MS, Krist AH, Cifuentes M, Green LA. Start-up and incremental practice expenses for behavior change interventions in primary care. Am J Prev Med. 2008 Nov;35(5 Suppl):S423-30. doi: 10.1016/j.amepre.2008.08.007.
- Results publication: PubMed 18929981Krist AH, Woolf SH, Frazier CO, Johnson RE, Rothemich SF, Wilson DB, Devers KJ, Kerns JW. An electronic linkage system for health behavior counseling effect on delivery of the 5A's. Am J Prev Med. 2008 Nov;35(5 Suppl):S350-8. doi: 10.1016/j.amepre.2008.08.010.
- Source of funding - Prescription for Health InnitiativeLink provided by the sponsor.
- Practice base research network study conducting the study - ACORNLink provided by the sponsor.
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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 Krist, MD study director
Virginia Commonwealth 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 Computer based care, Telephone counseling and Group visits in people with Unhealthy Diet, Exercise, Smoking, and Alcohol Use, run by Virginia Commonwealth 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 20 Jul 2012. 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?
Health behaviors (diet, exercise, smoking status, and alcohol use (time frame: 4 and 9 months post intervention). 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 NCT00292968, which also lists 5 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 20 Jul 2012; AzTrials last refreshed its copy on 26 Oct 2026.