- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01142804
WalkLink: Internet-based Walking Program (WalkLink)
WalkLink:Internet-based Walking Program for Cardiovascular Disease Risk-Reduction
The investigators propose a randomized controlled trial based on the Social Networks for Activity (SNAP) Model to evaluate: (1) the effectiveness of an internet-based fitness walking program delivered to patients with risk factors for cardiovascular disease and stroke; and (2) the contribution of social support networks to enhancing the effectiveness of the internet-based fitness walking program. The investigators will recruit 308 patients who are sedentary and have risk factors for cardiovascular disease and randomly assign them to one of the following groups: 1. Internet-based fitness walking program (WalkLink); 2. Internet-based fitness walking program plus additional social network intervention (WalkLink+); and 3. Minimal treatment control.
The primary specific aims of this study are to:
- Evaluate the effects of WalkLink and WalkLink+ relative to a minimal treatment control group on change in: physical activity, aerobic fitness, blood pressure, body composition, and body mass index (BMI), from baseline to posttest, and at 6-month follow-up.
- Compare the differential effectiveness of WalkLink+ to WalkLink on change in: physical activity, aerobic fitness, blood pressure, body composition and BMI from baseline to posttest, and at 6-month follow-up.
- Evaluate the mediator and moderator effects of selected individual-level self-management skills (goal setting, planning, self-monitoring), social support variables (number of activity partners, social cues for walking, social praise/reinforcement), and physical-ecological variables (neighborhood walkability, physical cues for walking) on WalkLink and WalkLink+ treatment outcomes.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Sedentary, defined as less than 150 minutes per week of moderate intensity activity
- Between the ages of 35 and 64
- Able to speak English
- Able to provide informed consent
- Able to participate in moderate-intensity physical activity (e.g., moderate pace walking)
Exclusion Criteria:
- No access to home or private work computer with Internet access
- Body mass index (BMI) greater than 39.9
- Systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg
- Bone, joint, or foot problems that interfere with walking
- Diabetes, pulmonary, or cardiovascular disease
- Consume 5 or more drinks of alcohol a day
- Currently pregnant
- Not living within the preselected study neighborhoods or plan to move from the local area during the study period
Study Plan
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: Enhanced Usual Care Group
Participants received weekly emailed tips of the week to provide support for walking.
|
Walking programs with various levels of support will be administered to determine which one is most effective.
Other Names:
|
|
Experimental: WalkLink Group
Participants received weekly emailed tips of the week, plus evidence-based online fitness walking program.
|
Walking programs with various levels of support will be administered to determine which one is most effective.
Other Names:
|
|
Experimental: WalkLink+ Group
Participants received weekly emailed tips, plus evidence-based online fitness walking program, plus online/in-person social network intervention.
|
Walking programs with various levels of support will be administered to determine which one is most effective.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Moderate Vigorous Activity
Time Frame: 9 months
|
Change in Moderate Vigorous Activity will be assessed using Actigraph accelerometers
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Risk Factors
Time Frame: 9 months
|
Aerobic fitness, blood pressure, body mass index, body composition
|
9 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Environmental Factors
Time Frame: 9 months
|
Built and social environment factors
|
9 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Liza Rovniak, PhD, MPH, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Publications and helpful links
General Publications
- Rovniak LS, Kong L, Hovell MF, Ding D, Sallis JF, Ray CA, Kraschnewski JL, Matthews SA, Kiser E, Chinchilli VM, George DR, Sciamanna CN. Engineering Online and In-Person Social Networks for Physical Activity: A Randomized Trial. Ann Behav Med. 2016 Dec;50(6):885-897. doi: 10.1007/s12160-016-9814-8.
- Rovniak LS, Sallis JF, Kraschnewski JL, Sciamanna CN, Kiser EJ, Ray CA, Chinchilli VM, Ding D, Matthews SA, Bopp M, George DR, Hovell MF. Engineering online and in-person social networks to sustain physical activity: application of a conceptual model. BMC Public Health. 2013 Aug 14;13:753. doi: 10.1186/1471-2458-13-753.
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
Other Study ID Numbers
- IRB-31708
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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