NCT01142804

Brief 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

June 10, 2010

Last Update Submit

August 12, 2015

Conditions

Keywords

Walking programsPhysical ActivityBehavior ModificationSocial Support

Outcome Measures

Primary Outcomes (1)

  • Moderate Vigorous Activity

    Change in Moderate Vigorous Activity will be assessed using Actigraph accelerometers

    9 months

Secondary Outcomes (1)

  • Health Risk Factors

    9 months

Other Outcomes (1)

  • Environmental Factors

    9 months

Study Arms (3)

Enhanced Usual Care Group

EXPERIMENTAL

Participants received weekly emailed tips of the week to provide support for walking.

Behavioral: Group

WalkLink Group

EXPERIMENTAL

Participants received weekly emailed tips of the week, plus evidence-based online fitness walking program.

Behavioral: Group

WalkLink+ Group

EXPERIMENTAL

Participants received weekly emailed tips, plus evidence-based online fitness walking program, plus online/in-person social network intervention.

Behavioral: Group

Interventions

GroupBEHAVIORAL

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

Also known as: Enhanced Usual Care, WalkLink, WalkLink+
Enhanced Usual Care GroupWalkLink GroupWalkLink+ Group

Eligibility Criteria

Age35 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Liza Rovniak, PhD, MPH

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine and Public Health Sciences

Study Record Dates

First Submitted

June 10, 2010

First Posted

June 11, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations