Cardiovascular DiseasePhase 1/2NCT00200317
Interactive Technologies to Increase Exercise Behavior
A Phase 1/2 study testing Internet and print-based interventions in people with Cardiovascular Disease, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Internet and print-based interventions
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2003to May 2006
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Sedentary, defined as exercising less than 90 minutes per week
- Lack of access to the Internet
- Lack of access to receiving mail
Who cannot join
- Coronary heart disease (history of myocardial infarction or symptoms of angina)
- Diabetes
- Stroke
- Osteoarthritis
- Osteoporosis
- Orthopedic problems which would limit treadmill testing
Show all 14Show fewer
- Other medical or psychological problems that could make adherence with the study protocol difficult or dangerous
- Consumption of three or more alcoholics drinks per day
- Current or planned pregnancy
- Planning to move from the area within the next year
- Current suicidal ideation or psychosis
- Current clinical depression
- Recent hospitalization due to a psychiatric disorder
- Taking medication that may impair physical activity tolerance or performance (e.g., beta blockers).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults.
Read the detailed description
As many as 75% of Americans do not engage in regular physical activity and 25% are completely inactive. The risk of cardiovascular disease is almost doubled among people who are physically inactive, comparable to the risk associated with increased systolic blood pressure, cigarette smoking, and elevated serum cholesterol. To make an impact on physical activity prevalence at the population level, research must focus at the interface between clinical efficacy trials and large-scale dissemination studies. Studies at this interface must compare proven interventions with new innovations that have the potential to reach large numbers of sedentary Americans.
The objective of this study is to determine the differential effect of intervention delivery channel (Tailored Internet versus Tailored Print) on physical activity adoption and maintenance in previously sedentary adults. To our knowledge, no studies have examined the efficacy of a Tailored Internet-based physical activity intervention. Thus, we will conduct a randomized controlled clinical trial comparing three groups, 1) Internet-based motivationally-tailored individualized feedback (Tailored Internet); 2) print-based motivationally-tailored individualized feedback which has previously shown to be efficacious (Tailored Print); and 3) websites currently available to the public (Standard Internet comparison group). Two hundred and forty healthy, sedentary women and men ages 18-65 will be randomly assigned to one of the three groups. The Tailored Internet and Tailored Print arms will be matched on frequency and content of contact. Data will be collected at baseline, 6, and 12 months using well-established physical activity and physical performance measures, as well as a comprehensive set of psychosocial questionnaires. Our primary hypothesis is that individuals randomized to the Tailored Internet arm will exhibit significantly higher levels of physical activity participation at 6 and 12 months than individuals in the Tailored Print arm due to the enhanced capabilities of the Internet (e.g., immediacy of feedback and enhanced graphics). And, in addition, subjects randomized to the Tailored Internet or Tailored Print conditions will exhibit significantly higher levels of physical activity participation at 6 and 12 months than those in the Standard Internet comparison condition. Other questions of interest will include an examination of potential moderators and mediators of the intervention-physical activity relationship. This study will contribute important information regarding the relative efficacy of Internet and print-based interventions, each of which can be utilized for widespread public health dissemination.
- Conditions
- Cardiovascular Disease
- Being tested
- Internet and print-based interventions
- Keywords
- Exercise, Internet, Print, Randomized Controlled Trial, Exercise Intervention
- Medical subject headings
- Cardiovascular Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet and print-based interventionsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
Secondary outcomes (2)
Minutes of physical activity per week based on objective physical activity monitor (ActiGraph);
Minutes of walking on a treadmill; and Estimated Vo2 on treadmill test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startFeb 2003
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Brown University
- Investigators
- Bess H Marcus, Ph.D., Principal investigator, Brown Medical School & The Miriam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00200317
- Sponsor's protocol ID
- R01HL069866
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 1 May 2007
- Results posted
- No
Publications
Marcus BH, Lewis BA, Williams DM, Dunsiger S, Jakicic JM, Whiteley JA, Albrecht AE, Napolitano MA, Bock BC, Tate DF, Sciamanna CN, Parisi AF. A comparison of Internet and print-based physical activity interventions. Arch Intern Med. 2007 May 14;167(9):944-9. doi: 10.1001/archinte.167.9.944.
PubMed 17502536
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Technologies to Increase Exercise Behavior
- ClinicalTrials.gov ID
- NCT00200317
- Acronym / sponsor ID
- R01HL069866
- Conditions
- Cardiovascular Disease
- Keywords
- Exercise, Internet, Print, Randomized Controlled Trial, Exercise Intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Brown University
- Study start
- Feb 2003
- Study completion
- May 2006 (actual)
- First posted
- 20 Sep 2005 (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.
The purpose of this study is to examine if an individually tailored Internet intervention is more efficacious than an individually tailored print-based intervention and standard Internet intervention for physical activity adoption and maintenance among sedentary adults.
Detailed description
As many as 75% of Americans do not engage in regular physical activity and 25% are completely inactive. The risk of cardiovascular disease is almost doubled among people who are physically inactive, comparable to the risk associated with increased systolic blood pressure, cigarette smoking, and elevated serum cholesterol. To make an impact on physical activity prevalence at the population level, research must focus at the interface between clinical efficacy trials and large-scale dissemination studies. Studies at this interface must compare proven interventions with new innovations that have the potential to reach large numbers of sedentary Americans.
The objective of this study is to determine the differential effect of intervention delivery channel (Tailored Internet versus Tailored Print) on physical activity adoption and maintenance in previously sedentary adults. To our knowledge, no studies have examined the efficacy of a Tailored Internet-based physical activity intervention. Thus, we will conduct a randomized controlled clinical trial comparing three groups, 1) Internet-based motivationally-tailored individualized feedback (Tailored Internet); 2) print-based motivationally-tailored individualized feedback which has previously shown to be efficacious (Tailored Print); and 3) websites currently available to the public (Standard Internet comparison group). Two hundred and forty healthy, sedentary women and men ages 18-65 will be randomly assigned to one of the three groups. The Tailored Internet and Tailored Print arms will be matched on frequency and content of contact. Data will be collected at baseline, 6, and 12 months using well-established physical activity and physical performance measures, as well as a comprehensive set of psychosocial questionnaires. Our primary hypothesis is that individuals randomized to the Tailored Internet arm will exhibit significantly higher levels of physical activity participation at 6 and 12 months than individuals in the Tailored Print arm due to the enhanced capabilities of the Internet (e.g., immediacy of feedback and enhanced graphics). And, in addition, subjects randomized to the Tailored Internet or Tailored Print conditions will exhibit significantly higher levels of physical activity participation at 6 and 12 months than those in the Standard Internet comparison condition. Other questions of interest will include an examination of potential moderators and mediators of the intervention-physical activity relationship. This study will contribute important information regarding the relative efficacy of Internet and print-based interventions, each of which can be utilized for widespread public health dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sedentary, defined as exercising less than 90 minutes per week
- Lack of access to the Internet
- Lack of access to receiving mail
Key exclusion criteria (14 listed)
- Coronary heart disease (history of myocardial infarction or symptoms of angina)
- Diabetes
- Stroke
- Osteoarthritis
- Osteoporosis
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 |
|---|---|---|
| Internet and print-based interventions | Behavioural | – |
Primary outcome
Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.
2 secondary outcomes
Minutes of physical activity per week based on objective physical activity monitor (ActiGraph);
Minutes of walking on a treadmill; and Estimated Vo2 on treadmill test.
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 1 May 2007.
- Derived from this study: PubMed 17502536Marcus BH, Lewis BA, Williams DM, Dunsiger S, Jakicic JM, Whiteley JA, Albrecht AE, Napolitano MA, Bock BC, Tate DF, Sciamanna CN, Parisi AF. A comparison of Internet and print-based physical activity interventions. Arch Intern Med. 2007 May 14;167(9):944-9. doi: 10.1001/archinte.167.9.944.
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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.
Bess H Marcus, Ph.D. principal investigator
Brown Medical School & The Miriam Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Internet and print-based interventions in people with Cardiovascular Disease, run by The Miriam Hospital 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 3 inclusion and 14 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 1 May 2007. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Minutes of physical activity per week based on 7-Day Physical Activity Recall Interview.. 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 NCT00200317, 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 1 May 2007.