Physical ActivityAIM-HINCT00534482
Evaluation of the "Americans in Motion - Healthy Interventions" Project
A study testing Enhanced Office, Conventional Office and AIM-HI program with enhanced feedback in people with Physical Activity and Diet, run by American Academy of Family Physicians at 1 site in United States.
Trial summary
This research project brings together the American Academy of Family Physicians (AAFP) National Research Network (AAFP-NRN) and the AAFP's public health initiative, Americans In Motion (AIM). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Diet, Mental Health
- What is being tested?
- Enhanced Office, Conventional Office and AIM-HI program with enhanced feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 950 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Oct 2009
- 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
- Age 18 or above
- BMI greater than or equal to 30
- Able to participate in moderate physical activity including a 3-minute step test without worsening an existing medical condition
- Life expectancy of greater than one year
- Able to read English or Spanish; and
- Able to be contacted via phone for follow-up with project staff
Who cannot join
- Too ill to participate
- A current diagnosis at the index visit of type 2 diabetes, hyperlipidemia, or coronary heart disease
- Doctor's evaluation of patient as not appropriate for physical activity
- Not capable of giving informed consent; and
- Unable to read English or Spanish, including blindness
Trial locations and contacts
1 site in 1 country.
United States1 site
American Academy of Family Physicians National Research Network
Leawood, Kansas, 66211
About this study
Official title: The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health
This research project brings together the American Academy of Family Physicians (AAFP) National Research Network (AAFP-NRN) and the AAFP's public health initiative, Americans In Motion (AIM). This project will develop and evaluate a practice improvement program to improve family physicians' delivery of effective patient-centered behavior change interventions for "fitness" (physical activity, nutrition and emotional well-being). The investigators seek to develop a unique program that positions fitness in a central role as "the treatment of choice" when dealing with issues of prevention and treatment of chronic conditions. In addition, this newly developed program is intended to help shift the paradigm of family physicians' use of common advice-giving methods to more effective patient-centered lifestyle counseling. Ultimately, this program will seek to improve care for all patients through fitness-related physician interventions.
Outcomes: This study design will allow the investigators to evaluate whether (and how) dissemination of educational materials impacts patient intervention by first engaging clinicians and staff in their personal use of these materials. This project will also evaluate the effects of the behavioral change tools, as well as, the added impact of new physiologic feedback measures (HOMA-IR and NMR Lipoprotein profiles) on physical activity and diet in study participants.
Conclusion: Primary care offices can become more effective settings to help patients improve physical activity, diet and emotional well-being. Demonstrating the value and impact of creating "healthy offices" that endorse and support clinicians, office staff and patients in the use of effective educational materials fits well with the new model of care as part of the AAFP's "Future of Family Medicine" initiatives, which emphasize the importance of lifestyle decisions and supporting successful changes in behaviors within primary care. This project will help define how to accomplish this.
Read the detailed description
Study Design: This trial will consist of a two-level randomized controlled trial. The first level of randomization will be performed at the practice level in order to study the impact of involving both clinicians and office staff in making their own personal changes (i.e., creating the "healthy" office)- a central component of AIM - on the translation of the project's educational tools to patients. The second level of randomization will occur at the patient level comparing two practice level interventions designed to improve nutrition, increase physical activity and improve emotional well-being. Furthermore, the effectiveness of the educational tools will be evaluated on self-reported diet, physical activity and emotional well-being and established physiologic measures on behavioral change. Both arms of the study will receive brief office-based counseling using established tools that have been compiled for this project. Practices will be asked to work on incorporating brief nutrition, physical activity and emotional well-being messages into routine care - either motivational in nature for people not willing to work on lifestyle changes, or goal-oriented for those working on changes. Patients in the intervention arm will also receive feedback concerning changes in two novel physiologic measures that correlate with improved nutrition and increased physical activity.
- Conditions
- Physical Activity, Diet, Mental Health
- Being tested
- Enhanced Office, Conventional Office, AIM-HI program with enhanced feedback, AIM-HI program and regular feedback
- Keywords
- fitness
- Medical subject headings
- Motor Activity, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced OfficeBehavioural
Clinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients
Conventional OfficeBehavioural
Conventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients.
AIM-HI program with enhanced feedbackBehavioural
Patient receives feedback on two novel indicators of their individual cardiovascular risk that: 1)appear to relate to obesity and lack of physical activity, and 2) may show relatively rapid change with improvements in these areas. These are the Homeostatic Assay - Insulin Resistance or HOMA-IR and Nuclear Molecular Resonance (NMR) lipoprotein profiles (NMRLP). These patients and their physicians also will receive periodic feedback on other outcome measures, including BMI, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
AIM-HI program and regular feedbackBehavioural
Patients will not receive feedback on two specific cardiovascular risk indicators (ie, Homeostatic Assay - Insulin Resistance, Nuclear Molecular Resonance lipoprotein profiles). However, patients will receive feedback on Body Mass Index, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment.
| Study group | Role | What they receive |
|---|---|---|
| A, 1, I | Experimental | Practice-level treatment group Receives: Behavioral: Enhanced Office |
| A, 1, II | Active comparator | Practice-level comparison group Receives: Behavioral: Conventional Office |
| B, 1, I | Experimental | Patient-level treatment group Receives: Behavioral: AIM-HI program with enhanced feedback |
| B, 1, II | Active comparator | Patient-level comparison group Receives: Behavioral: AIM-HI program and regular feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggregate patient assessment of practice involvement in patient health behaviors
Measured: 12 months
Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
Measured: 12 months
Spread of billing codes for physician fitness counseling
Measured: 12 months
Body Mass Index
Measured: baseline, 6, 9, and 12 months
Homeostatic Assay- Insulin Resistance
Measured: baseline, 3, 6, 9, and 12 months
Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
Measured: baseline, 3, 6, 9, and 12 months
3-Minute Step Test
Measured: baseline, 3, 6, 9, and 12 months
Blood Pressure
Measured: baseline, 3, 6, 9, and 12 months
Secondary outcomes (9)
Functional health status
Measured: baseline, 3, 6, 9, and 12 months
Quality of life and well-being
Measured: baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to diet
Measured: baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to physical activity
Measured: baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining healthy eating
Measured: baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining physical activity
Measured: baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining emotional health
Measured: baseline, 3, 6, 9, and 12 months
Diet and nutrition related items
Measured: baseline, 3, 6, 9, and 12 months
Physical activity related items
Measured: baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Academy of Family Physicians
- Sponsor type
- University, hospital or other
- Collaborators
- The PepsiCo Foundation
- Investigators
- Wilson D Pace, MD, FAAFP, Principal investigator, American Academy of Family Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534482
- Sponsor's protocol ID
- 07-034
- Acronym
- AIM-HI
- Status last verified
- May 2011
- First submitted
- 24 Sep 2007
- Last updated
- 10 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Stern SE, Williams K, Ferrannini E, DeFronzo RA, Bogardus C, Stern MP. Identification of individuals with insulin resistance using routine clinical measurements. Diabetes. 2005 Feb;54(2):333-9. doi: 10.2337/diabetes.54.2.333.
PubMed 15677489Shadid S, LaForge R, Otvos JD, Jensen MD. Treatment of obesity with diet/exercise versus pioglitazone has distinct effects on lipoprotein particle size. Atherosclerosis. 2006 Oct;188(2):370-6. doi: 10.1016/j.atherosclerosis.2005.10.038. Epub 2005 Nov 28.
PubMed 16313908McClernon FJ, Yancy WS Jr, Eberstein JA, Atkins RC, Westman EC. The effects of a low-carbohydrate ketogenic diet and a low-fat diet on mood, hunger, and other self-reported symptoms. Obesity (Silver Spring). 2007 Jan;15(1):182-7. doi: 10.1038/oby.2007.516.
PubMed 17228046
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Brief Primary Care Counseling and Novel Physiological Measures on Patient Physical and Emotional Health
- ClinicalTrials.gov ID
- NCT00534482
- Acronym / sponsor ID
- AIM-HI / 07-034
- Conditions
- Physical Activity, Diet, Mental Health
- Keywords
- fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- American Academy of Family PhysiciansUniversity, hospital or other
- Collaborators
- The PepsiCo Foundation
- Study start
- Jul 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 26 Sep 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.
This research project brings together the American Academy of Family Physicians (AAFP) National Research Network (AAFP-NRN) and the AAFP's public health initiative, Americans In Motion (AIM). This project will develop and evaluate a practice improvement program to improve family physicians' delivery of effective patient-centered behavior change interventions for "fitness" (physical activity, nutrition and emotional well-being). The investigators seek to develop a unique program that positions fitness in a central role as "the treatment of choice" when dealing with issues of prevention and treatment of chronic conditions. In addition, this newly developed program is intended to help shift the paradigm of family physicians' use of common advice-giving methods to more effective patient-centered lifestyle counseling. Ultimately, this program will seek to improve care for all patients through fitness-related physician interventions.
Outcomes: This study design will allow the investigators to evaluate whether (and how) dissemination of educational materials impacts patient intervention by first engaging clinicians and staff in their personal use of these materials. This project will also evaluate the effects of the behavioral change tools, as well as, the added impact of new physiologic feedback measures (HOMA-IR and NMR Lipoprotein profiles) on physical activity and diet in study participants.
Conclusion: Primary care offices can become more effective settings to help patients improve physical activity, diet and emotional well-being. Demonstrating the value and impact of creating "healthy offices" that endorse and support clinicians, office staff and patients in the use of effective educational materials fits well with the new model of care as part of the AAFP's "Future of Family Medicine" initiatives, which emphasize the importance of lifestyle decisions and supporting successful changes in behaviors within primary care. This project will help define how to accomplish this.
Detailed description
Study Design: This trial will consist of a two-level randomized controlled trial. The first level of randomization will be performed at the practice level in order to study the impact of involving both clinicians and office staff in making their own personal changes (i.e., creating the "healthy" office)- a central component of AIM - on the translation of the project's educational tools to patients. The second level of randomization will occur at the patient level comparing two practice level interventions designed to improve nutrition, increase physical activity and improve emotional well-being. Furthermore, the effectiveness of the educational tools will be evaluated on self-reported diet, physical activity and emotional well-being and established physiologic measures on behavioral change. Both arms of the study will receive brief office-based counseling using established tools that have been compiled for this project. Practices will be asked to work on incorporating brief nutrition, physical activity and emotional well-being messages into routine care - either motivational in nature for people not willing to work on lifestyle changes, or goal-oriented for those working on changes. Patients in the intervention arm will also receive feedback concerning changes in two novel physiologic measures that correlate with improved nutrition and increased physical activity.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A, 1, I | Experimental | Behavioral: Enhanced OfficePractice-level treatment group |
| A, 1, II | Active comparator | Behavioral: Conventional OfficePractice-level comparison group |
| B, 1, I | Experimental | Behavioral: AIM-HI program with enhanced feedbackPatient-level treatment group |
| B, 1, II | Active comparator | Behavioral: AIM-HI program and regular feedbackPatient-level comparison group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or above
- BMI greater than or equal to 30
- Able to participate in moderate physical activity including a 3-minute step test without worsening an existing medical condition
- Life expectancy of greater than one year
- Able to read English or Spanish; and
Key exclusion criteria (5 listed)
- Too ill to participate
- A current diagnosis at the index visit of type 2 diabetes, hyperlipidemia, or coronary heart disease
- Doctor's evaluation of patient as not appropriate for physical activity
- Not capable of giving informed consent; and
- Unable to read English or Spanish, including blindness
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 |
|---|---|---|
| Enhanced OfficeClinicians and office staff personally engage in AIM-HI fitness program, and promote program to patients | Behavioural | A, 1, I |
| Conventional OfficeConventional office: Clinicians and office staff are not personally engaged in the AIM-HI fitness program, but promote program to patients. | Behavioural | A, 1, II |
| AIM-HI program with enhanced feedbackPatient receives feedback on two novel indicators of their individual cardiovascular risk that: 1)appear to relate to obesity and lack of physical activity, and 2) may show relatively rapid change with improvements in these areas. These are the Homeostatic Assay - Insulin Resistance or HOMA-IR and Nuclear Molecular Resonance (NMR) lipoprotein profiles (NMRLP). These patients and their physicians also will receive periodic feedback on other outcome measures, including BMI, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment. | Behavioural | B, 1, I |
| AIM-HI program and regular feedbackPatients will not receive feedback on two specific cardiovascular risk indicators (ie, Homeostatic Assay - Insulin Resistance, Nuclear Molecular Resonance lipoprotein profiles). However, patients will receive feedback on Body Mass Index, blood pressure, a 3-minute step test, eating assessment, physical activity assessment, and emotional well-being assessment. | Behavioural | B, 1, II |
Primary outcome
Aggregate patient assessment of practice involvement in patient health behaviors
Time frame: 12 months
Aggregate clinician and practice staff assessment of practice involvement in patient healthy behaviors
Time frame: 12 months
Spread of billing codes for physician fitness counseling
Time frame: 12 months
Body Mass Index
Time frame: baseline, 6, 9, and 12 months
Homeostatic Assay- Insulin Resistance
Time frame: baseline, 3, 6, 9, and 12 months
Nuclear Molecular Resonance (NMR) Lipoprotein Profiles
Time frame: baseline, 3, 6, 9, and 12 months
3-Minute Step Test
Time frame: baseline, 3, 6, 9, and 12 months
Blood Pressure
Time frame: baseline, 3, 6, 9, and 12 months
9 secondary outcomes
Functional health status
Time frame: baseline, 3, 6, 9, and 12 months
Quality of life and well-being
Time frame: baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to diet
Time frame: baseline, 3, 6, 9, and 12 months
Treatment self-regulation items related to physical activity
Time frame: baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining healthy eating
Time frame: baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining physical activity
Time frame: baseline, 3, 6, 9, and 12 months
Perceived competence for maintaining emotional health
Time frame: baseline, 3, 6, 9, and 12 months
Diet and nutrition related items
Time frame: baseline, 3, 6, 9, and 12 months
Physical activity related items
Time frame: baseline, 3, 6, 9, and 12 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 10 May 2011.
- Background: PubMed 15677489Stern SE, Williams K, Ferrannini E, DeFronzo RA, Bogardus C, Stern MP. Identification of individuals with insulin resistance using routine clinical measurements. Diabetes. 2005 Feb;54(2):333-9. doi: 10.2337/diabetes.54.2.333.
- Background: PubMed 16313908Shadid S, LaForge R, Otvos JD, Jensen MD. Treatment of obesity with diet/exercise versus pioglitazone has distinct effects on lipoprotein particle size. Atherosclerosis. 2006 Oct;188(2):370-6. doi: 10.1016/j.atherosclerosis.2005.10.038. Epub 2005 Nov 28.
- Background: PubMed 17228046McClernon FJ, Yancy WS Jr, Eberstein JA, Atkins RC, Westman EC. The effects of a low-carbohydrate ketogenic diet and a low-fat diet on mood, hunger, and other self-reported symptoms. Obesity (Silver Spring). 2007 Jan;15(1):182-7. doi: 10.1038/oby.2007.516.
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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.
Wilson D Pace, MD, FAAFP principal investigator
American Academy of Family Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Office, Conventional Office and AIM-HI program with enhanced feedback in people with Physical Activity and Diet, run by American Academy of Family Physicians 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 6 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 10 May 2011. 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?
Aggregate patient assessment of practice involvement in patient health behaviors (time frame: 12 months). The study lists 8 primary outcomes in all. 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 NCT00534482, which also lists 3 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 10 May 2011.