WalkLink: Internet-based Walking Program
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Purpose
The investigators propose a randomized controlled trial based on the Behavioral Ecological 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 310 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 social support network intervention (WalkLink+); and 3. Minimal treatment control group (usual care).
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: aerobic fitness, walking quantity, blood pressure, body composition, body mass index (BMI), and amount and frequency of moderate and vigorous walking and physical activity from baseline to posttest, and at 6-month follow-up.
- Compare the differential effectiveness of WalkLink+ to WalkLink on change in: aerobic fitness, walking quantity, blood pressure, body composition, BMI, and amount and frequency of moderate and vigorous walking and physical activity 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 and networks, social cues for walking, social praise/reinforcement), and physical-ecological variables (neighborhood walkability, physical cues for walking) on WalkLink and WalkLink+ treatment outcomes.
| Condition | Intervention |
|---|---|
|
Physical Activity Behavior Modification |
Other: WalkLink Walking Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | WalkLink: Email-based Walking Program for Cardiovascular Disease Risk-Reduction |
- Estimated Change in VO2max [ Time Frame: 9 months ] [ Designated as safety issue: No ]Change in estimated VO2max will be measured using a submaximal treadmill test.
- Environmental factors [ Time Frame: 9 months ] [ Designated as safety issue: No ]Environmental factors will be assessed through self-report measures.
| Estimated Enrollment: | 310 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: Enhanced Usual Care | |
| Experimental: WalkLink Group |
Other: WalkLink Walking Program
Walking programs with various levels of support will be administered to determine which one is most effective.
|
| Experimental: WalkLink+ Group |
Other: WalkLink Walking Program
Walking programs with various levels of support will be administered to determine which one is most effective.
|
Eligibility| Ages Eligible for Study: | 35 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Sedentary, defined as less than 150 minutes per week of moderate intensity activity, or less than 60 minutes per week of vigorous 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
- Major psychiatric disorders including Bipolar I or Psychotic Disorders
- Currently pregnant
- Not living within the preselected study neighborhoods or plan to move from the local area during the study period
Contacts and Locations| Contact: Liza Rovniak, PhD, MPH | lrovniak@hmc.psu.edu | |
| Contact: Elizabeth Kiser, B.S. | 531-0003 ext 284160 | ekiser@psu.edu |
| United States, Pennsylvania | |
| Penn State College of Medicine, Penn State Milton S. Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Liza Rovniak, Ph.D, MPH lrovniak@hmc.psu.edu | |
| Contact: Elizabeth Kiser, B.S. 717-531-0003 ext 284160 ekiser@psu.edu | |
| Principal Investigator: | Liza Rovniak, PhD, MPH | Penn State College of Medicine, Penn State Milton S. Hershey Medical Center |
More Information
No publications provided
| Responsible Party: | Dr. Liza Rovniak, Assistant Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT01142804 History of Changes |
| Other Study ID Numbers: | IRB-31708 |
| Study First Received: | June 10, 2010 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Milton S. Hershey Medical Center:
|
Walking programs Physical Activity Behavior Modification Social Support |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013