Physical ActivityPhase 1NCT01218412
Web-based Physical Activity Program
A Phase 1 study testing Web-based Motivational Interviewing in people with Physical Activity, run by Karnes, Sasha at 1 site in United States.
Trial summary
The specific aims of the proposed study are: 1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an informational web-based comparison group, in enhancing physical activity (PA) participation; and 2. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- Web-based Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2016
- Phase
- Phase 1
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults referred through primary care due to insufficient physical activity standards based on Centers for Disease Control (CDC) guidelines for aerobic activity.
- Must have internet access and e-mail.
- Cleared by physician for physical activity participation.
Who cannot join
- Greater than 10,000 steps per day on average based on baseline pedometer screening over the course of 7 days.
Trial locations and contacts
1 site in 1 country.
Sasha L. Karnes, M.S. contact
United States1 site, 1 recruiting
- Recruiting
Aurora RiverCenter
Milwaukee, Wisconsin, 53212
Tomas Kubrican, M.D., tomas.kubrican@aurora.org
Sasha L. Karnes, M.S.
About this study
Official title: Investigation of Web-based Motivational Interviewing to Increase Physical Activity Participation Among Adults
The specific aims of the proposed study are:
- 1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an informational web-based comparison group, in enhancing physical activity (PA) participation; and
- 2. To assess the mechanisms by which web-based MI enhances PA through changes in targeted cognitive mediators.
Read more
The specific hypotheses of the study include that:
- Hypothesis 1: Web-based MI will increase PA;
- Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased readiness to participate in PA;
- Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;
- Hypothesis 4: Cognitive variables will mediate increases in PA participation.
Read the detailed description
Increasing physical activity (PA) is a public health priority. There is preliminary support for application of Motivational Interviewing (MI) for physical activity (PA), web-applications for PA promotion, web-based MI for behavior change, and finally web-based MI for PA. Based on collective findings in these areas of inquiry, it is necessary to investigate the efficacy of MI as a method that lends readily to practical applications for PA promotion. The current study seeks to investigate whether web-based MI can be applied in an adult population to enhance PA participation using a physician referral scheme. Additionally, mechanisms of behavior change are considered in order to inform future research and intervention.
- Conditions
- Physical Activity
- Being tested
- Web-based Motivational Interviewing
- Keywords
- Physical Activity, Motivational Interviewing, Web-based, Physician Referral
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based Motivational InterviewingBehavioural
Participants will engage in 4 sessions of web-based motivational interviewing over the course of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Web-based, Mi=Based Intervention | Experimental | 4 session web-based, MI-based intervention. Receives: Behavioral: Web-based Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity (pedometer recordings)
Physical activity will be assessed using pedometers.
Measured: 1 week post-intervention
Physical activity (self-report)
Physical activity will be assessed using a self-report inventory.
Measured: 3-months post-intervention
Secondary outcomes (1)
Cognitive Mediators
Cognitive mediators of physical activity participation including self-efficacy, readiness to change, motivation, intention, enjoyment, and decisional balance for physical activity will be assessed.
Measured: 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startOct 2014
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karnes, Sasha
- Collaborators
- University of Wisconsin, Whitewater
- Responsible party
- Principal investigator, Sasha Karnes, Karnes, Sasha
- Investigators
- Sasha L. Karnes, M.S., Principal investigator, University of Wisconsin, Milwaukee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218412
- Sponsor's protocol ID
- 10-84E
- Status last verified
- Apr 2014
- First submitted
- 4 Oct 2010
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Web-based Motivational Interviewing to Increase Physical Activity Participation Among Adults
- ClinicalTrials.gov ID
- NCT01218412
- Acronym / sponsor ID
- 10-84E
- Conditions
- Physical Activity
- Keywords
- Physical Activity, Motivational Interviewing, Web-based, Physician Referral
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Karnes, Sasha
- Collaborators
- University of Wisconsin, Whitewater
- Study start
- Oct 2014
- Primary completion
- May 2016 (estimated)
- First posted
- 11 Oct 2010 (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 specific aims of the proposed study are:
- 1. To determine if web-based Motivational Interviewing (MI) is effective, compared to an informational web-based comparison group, in enhancing physical activity (PA) participation; and
- 2. To assess the mechanisms by which web-based MI enhances PA through changes in targeted cognitive mediators.
The specific hypotheses of the study include that:
- Hypothesis 1: Web-based MI will increase PA;
- Hypothesis 2: Web-based MI will lead to stage progression in the direction of increased readiness to participate in PA;
- Hypothesis 3: Web-based MI will influence theoretically identified cognitive variables;
- Hypothesis 4: Cognitive variables will mediate increases in PA participation.
Detailed description
Increasing physical activity (PA) is a public health priority. There is preliminary support for application of Motivational Interviewing (MI) for physical activity (PA), web-applications for PA promotion, web-based MI for behavior change, and finally web-based MI for PA. Based on collective findings in these areas of inquiry, it is necessary to investigate the efficacy of MI as a method that lends readily to practical applications for PA promotion. The current study seeks to investigate whether web-based MI can be applied in an adult population to enhance PA participation using a physician referral scheme. Additionally, mechanisms of behavior change are considered in order to inform future research and intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Web-based, Mi=Based Intervention | Experimental | Behavioral: Web-based Motivational Interviewing4 session web-based, MI-based intervention. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults referred through primary care due to insufficient physical activity standards based on Centers for Disease Control (CDC) guidelines for aerobic activity.
- Must have internet access and e-mail.
- Cleared by physician for physical activity participation.
Key exclusion criteria (1 listed)
- Greater than 10,000 steps per day on average based on baseline pedometer screening over the course of 7 days.
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 |
|---|---|---|
| Web-based Motivational InterviewingParticipants will engage in 4 sessions of web-based motivational interviewing over the course of 4 weeks. | Behavioural | Web-based, Mi=Based Intervention |
Primary outcome
Physical Activity (pedometer recordings)
Time frame: 1 week post-intervention
Physical activity will be assessed using pedometers.
Physical activity (self-report)
Time frame: 3-months post-intervention
Physical activity will be assessed using a self-report inventory.
1 secondary outcome
Cognitive Mediators
Time frame: 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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.
Sasha L. Karnes, M.S. contact
Sasha L. Karnes, M.S. principal investigator
University of Wisconsin, Milwaukee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Web-based Motivational Interviewing in people with Physical Activity, run by Karnes, Sasha 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 1 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: status not confirmed, as of the sponsor's last update on 6 Apr 2015. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sasha L. Karnes, M.S. (sashaw@uwm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity (pedometer recordings) (time frame: 1 week post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2015.