WalkLink: Internet-based Walking Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Milton S. Hershey Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dr. Liza Rovniak, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01142804
First received: June 10, 2010
Last updated: October 7, 2011
Last verified: October 2011
  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:

  1. 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.
  2. 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.
  3. 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

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142804

Contacts
Contact: Liza Rovniak, PhD, MPH lrovniak@hmc.psu.edu
Contact: Elizabeth Kiser, B.S. 531-0003 ext 284160 ekiser@psu.edu

Locations
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   
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Liza Rovniak, PhD, MPH Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

No publications provided by Milton S. Hershey Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014