- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01218412
Web-based Physical Activity Program
April 3, 2015 updated by: Sasha Karnes, Karnes, Sasha
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.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
132
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53212
- Recruiting
- Aurora RiverCenter
-
Contact:
- Tomas Kubrican, M.D.
- Email: tomas.kubrican@aurora.org
-
Principal Investigator:
- Sasha L. Karnes, M.S.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Greater than 10,000 steps per day on average based on baseline pedometer screening over the course of 7 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Web-based, Mi=Based Intervention
4 session web-based, MI-based intervention.
|
Participants will engage in 4 sessions of web-based motivational interviewing over the course of 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity (pedometer recordings)
Time Frame: 1 week post-intervention
|
Physical activity will be assessed using pedometers.
|
1 week post-intervention
|
|
Physical activity (self-report)
Time Frame: 3-months post-intervention
|
Physical activity will be assessed using a self-report inventory.
|
3-months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive Mediators
Time Frame: 3 months post intervention
|
Cognitive mediators of physical activity participation including self-efficacy, readiness to change, motivation, intention, enjoyment, and decisional balance for physical activity will be assessed.
|
3 months post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sasha L. Karnes, M.S., University of Wisconsin, Milwaukee
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2014
Primary Completion (Anticipated)
May 1, 2016
Study Registration Dates
First Submitted
October 4, 2010
First Submitted That Met QC Criteria
October 7, 2010
First Posted (Estimate)
October 11, 2010
Study Record Updates
Last Update Posted (Estimate)
April 6, 2015
Last Update Submitted That Met QC Criteria
April 3, 2015
Last Verified
April 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 10-84E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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