HypertensionPhase 1NCT00242658
Computerized Health Education to Promote Physical Activity
A Phase 1 study testing Tailored Physical Activity Intervention in people with Hypertension, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Tailored Physical Activity Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Mar 2008
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- Congestive heart failure
- Peripheral vascular disease
- Cerebrovascular disease
- Chronic obstructive pulmonary disease
- Arrhythmia
- Recurrent seizures
- Dizziness
- Balance problems
- Psychoses
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Jefferson Family Medicine Associates
Philadelphia, Pennsylvania, 19107
Jefferson Medical College, Department of Health Policy
Philadelphia, Pennsylvania, 19107
About this study
Official title: Computerized Physical Activity Promotion in Primary Care
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Tailored Physical Activity Intervention
- Keywords
- Physical Activity, Wellness Programs, Health Promotion, Blood Pressure, High
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Physical Activity InterventionBehavioural
Also called Exercise Intervention
Tailored physical activity computer reports will be provided to patients and physicians.
| Study group | Role | What they receive |
|---|---|---|
| Tailored Physical Activity Intervention Group | Experimental | Four feedback reports aimed to increase physical activity. Receives: Behavioral: Tailored Physical Activity Intervention |
| No Tailored Physical Activity Intervention Group | No intervention | General reports on preventive screening based on responses to preventive screening questions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: Baseline and 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 Oct 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher N. Sciamanna, MD, MPH, Study chair, Jefferson Medical College, Department of Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242658
- Sponsor's protocol ID
- 269
- Other IDs
- 7R01HL067005-03, 02F.214 CHIP
- Status last verified
- Nov 2012
- First submitted
- 19 Oct 2005
- Last updated
- 12 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20621262
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Physical Activity Promotion in Primary Care
- ClinicalTrials.gov ID
- NCT00242658
- Acronym / sponsor ID
- 269
- Conditions
- Hypertension
- Keywords
- Physical Activity, Wellness Programs, Health Promotion, Blood Pressure, High
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Thomas Jefferson University
- Study start
- May 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Oct 2005 (estimated)
- Results
- Posted 6 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored Physical Activity Intervention Group | Experimental | Behavioral: Tailored Physical Activity InterventionFour 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| Tailored Physical Activity InterventionAlso: Exercise InterventionTailored physical activity computer reports will be provided to patients and physicians. | Behavioural | Tailored Physical Activity Intervention Group |
Primary outcome
7-Day Physical Activity Recall (7-Day PAR)
Time frame: 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.
1 secondary outcome
Change in Behavioral Processes of Change Between Baseline and 6 Months
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20621262Carroll 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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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.
Christopher N. Sciamanna, MD, MPH study chair
Jefferson Medical College, Department of Health Policy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tailored Physical Activity Intervention in people with Hypertension, run by Milton S. Hershey Medical Center at 2 sites 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 5 inclusion and 15 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 12 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
7-Day Physical Activity Recall (7-Day PAR) (time frame: 6 months). 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 NCT00242658, which also lists 1 linked publication.
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 12 Nov 2012.