- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00729040
Enhancing Adherence by Building Online Communities
Enhancing Adherence to an Internet-Mediated Walking Program by Building Online Communities
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stepping Up to Health with eCommunities is a study that takes what we already know about motivating sedentary, chronically ill people to walk, and begins to explore what it takes to keep people motivated to exercise over time: the ability to self-monitor behavior with accurate ecological momentary assessments.
We have theorized that peer support, monitoring and competition are ways in which people can stay motivated to meet their walking goals; thus, we have built into this intervention online forums for participants to communicate with each other and garner support, as well as a pilot one-to-many competitive game based on the percent of an individual's goal met.
Our research question is whether online community participation can increase adherence to an Internet-mediated walking program, which consists of an uploading pedometer, and going to a website to receive graphical and textual feedback as to whether participants are meeting gradually increasing walking goals. Three hundred participants will spend four months in this randomized, controlled trial to compare the intervention alone to the intervention plus online community support.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must have one or more of the following: Coronary artery disease (CAD); BMI 25 or higher; Type 2 diabetes
- Must be sedentary, defined by less than 150 minutes of self-reported activity per week
- Must be 18 or older
- Must have access to a computer with an Internet connection, a USB port, and Windows 2000 (latest service pack), XP or Vista
- Must be a regular email user (checking weekly)
- Must be able to communicate in English
Exclusion Criteria:
- Pregnant
- Cannot walk a block (self-report)
- Not competent to sign consent
- Unable to obtain medical clearance from a treating physician (primary care, cardiologist, endocrinologist)
- Type 1 diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 1
Stepping Up to Health only
|
Internet-mediated walking program with pedometers, goal-setting and tailored messaging
|
|
Experimental: 2
Stepping up to Health PLUS online message boards to talk with other participants
|
Internet-mediated walking program with pedometers, goal-setting and tailored messaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total steps
Time Frame: last 30 days of intervention
|
last 30 days of intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
dropout rate
Time Frame: Four months
|
Four months
|
|
days and hours pedometer worn
Time Frame: four months
|
four months
|
|
login frequency
Time Frame: four months
|
four months
|
|
upload frequency
Time Frame: four months
|
four months
|
|
content of posts (qualitative)
Time Frame: four months
|
four months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Caroline R Richardson, MD, University of Michigan Health System Dept. of Family Medicine
Publications and helpful links
General Publications
- Richardson CR, Buis LR, Janney AW, Goodrich DE, Sen A, Hess ML, Mehari KS, Fortlage LA, Resnick PJ, Zikmund-Fisher BJ, Strecher VJ, Piette JD. An online community improves adherence in an internet-mediated walking program. Part 1: results of a randomized controlled trial. J Med Internet Res. 2010 Dec 17;12(4):e71. doi: 10.2196/jmir.1338.
- Buis LR, Janney AW, Hess ML, Culver SA, Richardson CR. Barriers encountered during enrollment in an internet-mediated randomized controlled trial. Trials. 2009 Aug 23;10:76. doi: 10.1186/1745-6215-10-76.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 57408
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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