| ID | Type | Description | Link |
|---|---|---|---|
| 7R01HL067005-03 | U.S. NIH Grant/Contract | View source | |
| 02F.214 CHIP |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Thomas Jefferson University | OTHER |
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This study will test the efficacy of providing primary care physicians and their patients with computer-tailored information, based on patients' responses to survey questions. The health education messages are designed to encourage patients to become physically active and to encourage physicians to counsel their patients about exercise.
The main objective of this study is to determine, via a 6-month randomized controlled study, the efficacy of providing tailored physical activity computer reports to patients and physicians. The primary outcome is minutes of physical activity measured by the 7-Day Physical Activity Recall interview at 6 months. The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Physical Activity Intervention Group | Experimental | Four feedback reports aimed to increase physical activity. |
|
| No Tailored Physical Activity Intervention Group | No Intervention | General reports on preventive screening based on responses to preventive screening questions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Physical Activity Intervention | Behavioral | Tailored physical activity computer reports will be provided to patients and physicians. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 7-Day Physical Activity Recall (7-Day PAR) | Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Behavioral Processes of Change Between Baseline and 6 Months | Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, "I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher N. Sciamanna, MD, MPH | Jefferson Medical College, Department of Health Policy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Family Medicine Associates | Philadelphia | Pennsylvania | 19107 | United States | ||
| Jefferson Medical College, Department of Health Policy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20621262 | Derived | Carroll JK, Lewis BA, Marcus BH, Lehman EB, Shaffer ML, Sciamanna CN. Computerized tailored physical activity reports. A randomized controlled trial. Am J Prev Med. 2010 Aug;39(2):148-56. doi: 10.1016/j.amepre.2010.04.005. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Physical Activity Intervention Group | The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. |
| FG001 | No Tailored Physical Activity Intervention Group | The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tailored Physical Activity Intervention Group | The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 7-Day Physical Activity Recall (7-Day PAR) | Minutes of physical activity measured by the 7-Day Physical Activity Recall (7-Day PAR), which is an interviewer-administered self-report physical activity measure of minutes spent in moderate and vigorous intensity leisure and non-leisure activities over the preceding 7 days. It was administered to study participants at baseline and 6 months. | Posted | Jun 2010 | Mean | 95% Confidence Interval | minutes | 6 months |
|
6 months
Adverse events were collected by participants contacting the research team. Serious and/or other non-serious adverse events were not collected/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored Physical Activity Intervention Group | The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants' needs; they also included an activity prescription. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chris Sciamanna, MD, MPH | Penn State Milton S. Hershey Medical Center | 717-531-8161 | cns10@psu.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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|
| Baseline and 6 months |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| BG001 | No Tailored Physical Activity Intervention Group | The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| No Tailored Physical Activity Intervention Group |
The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions. |
|
|
| Secondary | Change in Behavioral Processes of Change Between Baseline and 6 Months | Behavioral processes were assessed by asking participants to rate their responses to 24 statements on a Likert scale (1 = never to 5 = repeatedly) to statements such as, "I tell myself I am able to be physically active if I want to. To create the overall measure, individual items are averaged. Higher numbers represent greater use of behavioral processes of change, so that the overall scale retains a maximum of 5.0 and minimum value of 1.0. The scale values are not numerical, they represent scores on the scale, where 5=repeatedly and 1=never. | Posted | Jun 2010 | Mean | 95% Confidence Interval | Scores on a Scale | Baseline and 6 months |
|
|
|
| 0 |
| 187 |
| 0 |
| 187 |
| EG001 | No Tailored Physical Activity Intervention Group | The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions. | 0 | 207 | 0 | 207 |
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