Hypertension
Conditions
Keywords
Physical Activity, Wellness Programs, Health Promotion, Blood Pressure, High
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTailored Physical Activity Intervention
Tailored physical activity computer reports will be provided to patients and physicians.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Thomas Jefferson University
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Ability to speak and read English * Current patient of a physician participating in this study (if selecting a new physician, may deliberately select one that is involved in the study, in order to participate) * Ability to complete all written surveys * Accessible for follow-up telephone surveys * Ability to undergo exercise testing
Exclusion criteria
* Currently participating in another research study * Planning to move out of the Philadelphia area * Unable to walk without pain * Pregnant or planning to become pregnant in the year following study entry * Excessive drinking * Coronary heart disease * Congestive heart failure * Peripheral vascular disease * Cerebrovascular disease * Chronic obstructive pulmonary disease * Arrhythmia * Recurrent seizures * Dizziness * Balance problems * Psychoses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-Day Physical Activity Recall (7-Day PAR) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral Processes of Change Between Baseline and 6 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 187 |
| 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. | 207 |
| Total | 394 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 22 | 19 |
Baseline characteristics
| Characteristic | No Tailored Physical Activity Intervention Group | Tailored Physical Activity Intervention Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 207 Participants | 187 Participants | 394 Participants |
| Age Continuous | 48.4 years STANDARD_DEVIATION 11.1 | 44.1 years STANDARD_DEVIATION 11.2 | 46.4 years STANDARD_DEVIATION 11.4 |
| Region of Enrollment United States | 207 participants | 187 participants | 394 participants |
| Sex: Female, Male Female | 165 Participants | 167 Participants | 332 Participants |
| Sex: Female, Male Male | 42 Participants | 20 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 187 | 0 / 207 |
| serious Total, serious adverse events | 0 / 187 | 0 / 207 |
Outcome results
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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Tailored Physical Activity Intervention Group | 7-Day Physical Activity Recall (7-Day PAR) | 54.85 minutes |
| No Tailored Physical Activity Intervention Group | 7-Day Physical Activity Recall (7-Day PAR) | 44.89 minutes |
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tailored Physical Activity Intervention Group | Change in Behavioral Processes of Change Between Baseline and 6 Months | 0.52 Scores on a Scale | 95% Confidence Interval 0 |
| No Tailored Physical Activity Intervention Group | Change in Behavioral Processes of Change Between Baseline and 6 Months | 0.18 Scores on a Scale | 95% Confidence Interval 0 |