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- Klinische proef NCT01142804
WalkLink: Internet-based Walking Program (WalkLink)
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.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Pennsylvania
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Hershey, Pennsylvania, Verenigde Staten, 17033
- Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Enhanced Usual Care Group
Participants received weekly emailed tips of the week to provide support for walking.
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Walking programs with various levels of support will be administered to determine which one is most effective.
Andere namen:
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Experimenteel: WalkLink Group
Participants received weekly emailed tips of the week, plus evidence-based online fitness walking program.
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Walking programs with various levels of support will be administered to determine which one is most effective.
Andere namen:
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Experimenteel: WalkLink+ Group
Participants received weekly emailed tips, plus evidence-based online fitness walking program, plus online/in-person social network intervention.
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Walking programs with various levels of support will be administered to determine which one is most effective.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Moderate Vigorous Activity
Tijdsspanne: 9 months
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Change in Moderate Vigorous Activity will be assessed using Actigraph accelerometers
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9 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Health Risk Factors
Tijdsspanne: 9 months
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Aerobic fitness, blood pressure, body mass index, body composition
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9 months
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Environmental Factors
Tijdsspanne: 9 months
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Built and social environment factors
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9 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Liza Rovniak, PhD, MPH, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- IRB-31708
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