Physical ActivityWalkLinkNCT01142804
WalkLink: Internet-based Walking Program
A study testing Group in people with Physical Activity, run by Milton S. Hershey Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 35 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
- Conditions
- Physical Activity
- Being tested
- Group
- Keywords
- Walking programs, Physical Activity, Behavior Modification, Social Support
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GroupBehavioural
Also called Enhanced Usual Care, WalkLink, WalkLink+
Walking programs with various levels of support will be administered to determine which one is most effective.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care Group | Experimental | Participants received weekly emailed tips of the week to provide support for walking. Receives: Behavioral: Group |
| WalkLink Group | Experimental | Participants received weekly emailed tips of the week, plus evidence-based online fitness walking program. Receives: Behavioral: Group |
| WalkLink+ Group | Experimental | Participants received weekly emailed tips, plus evidence-based online fitness walking program, plus online/in-person social network intervention. Receives: Behavioral: Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Moderate Vigorous Activity
Change in Moderate Vigorous Activity will be assessed using Actigraph accelerometers
Measured: 9 months
Secondary outcomes (1)
Health Risk Factors
Aerobic fitness, blood pressure, body mass index, body composition
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liza Rovniak, Milton S. Hershey Medical Center
- Investigators
- Liza Rovniak, PhD, MPH, Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142804
- Sponsor's protocol ID
- IRB-31708
- Acronym
- WalkLink
- Status last verified
- Aug 2015
- First submitted
- 10 Jun 2010
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 27405724Rovniak 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.
PubMed 23945138
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WalkLink:Internet-based Walking Program for Cardiovascular Disease Risk-Reduction
- ClinicalTrials.gov ID
- NCT01142804
- Acronym / sponsor ID
- WalkLink / IRB-31708
- Conditions
- Physical Activity
- Keywords
- Walking programs, Physical Activity, Behavior Modification, Social Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care Group | Experimental | Behavioral: GroupParticipants received weekly emailed tips of the week to provide support for walking. |
| WalkLink Group | Experimental | Behavioral: GroupParticipants received weekly emailed tips of the week, plus evidence-based online fitness walking program. |
| WalkLink+ Group | Experimental | Behavioral: GroupParticipants received weekly emailed tips, plus evidence-based online fitness walking program, plus online/in-person social network intervention. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GroupAlso: Enhanced Usual Care, WalkLink, WalkLink+Walking programs with various levels of support will be administered to determine which one is most effective. | Behavioural | Enhanced Usual Care Group, WalkLink Group, WalkLink+ Group |
Primary outcome
Moderate Vigorous Activity
Time frame: 9 months
Change in Moderate Vigorous Activity will be assessed using Actigraph accelerometers
1 secondary outcome
Health Risk Factors
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
- Derived from this study: PubMed 27405724Rovniak 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.
- Derived from this study: PubMed 23945138Rovniak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liza Rovniak, PhD, MPH principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group in people with Physical Activity, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate Vigorous Activity (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01142804, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2015.