WalkLink: Internet-based Walking Program

Physical Activity Clinical Trial

— WalkLink  

Official title:

WalkLink:Internet-based Walking Program for Cardiovascular Disease Risk-Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01142804
• Other study ID #: IRB-31708
• Status: Completed
• Phase: N/A
• First received: June 10, 2010
• Last updated: August 12, 2015
• Start date: August 2010
• Est. completion date: August 2012

Study information

• Verified date: August 2015
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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:

1. 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.

2. 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.

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, social cues for walking, social praise/reinforcement), and physical-ecological variables (neighborhood walkability, physical cues for walking) on WalkLink and WalkLink+ treatment outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Group
Walking programs with various levels of support will be administered to determine which one is most effective.

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Environmental Factors	Built and social environment factors	9 months	No
Primary	Moderate Vigorous Activity	Change in Moderate Vigorous Activity will be assessed using Actigraph accelerometers	9 months	No
Secondary	Health Risk Factors	Aerobic fitness, blood pressure, body mass index, body composition	9 months	No