PH iWell Study to Compare an Online Interactive Technology to Self-directed Care in Overweight or Obese Individuals
NCT ID: NCT01325376
Last Updated: 2011-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
500 participants
INTERVENTIONAL
2010-10-31
2012-10-31
Brief Summary
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The primary aim is to test the hypothesis that dynamic online interactive technology intervention is more effective than self-directed program in obtaining and maintaining weight loss and other biometric improvements.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Self directed
Self directed
Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
Technology assisted health behavior
The intervention arm will have access to a dynamic online environment with social networking and device data uploads that include activity data, weight data and laboratory data at frequent intervals to nudge optimal health behavior.
Technology assisted health behavior
Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC. Also serves as a social networking site.
Interventions
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Technology assisted health behavior
Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC. Also serves as a social networking site.
Self directed
Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* overweight or obese men and women with BMI between 24 and 38, inclusive
* concerned about weight/health (and motivated in losing weight)
* stable medications for past 3 months
* willing/able to use Web-based services
* willingness not to use weight loss medications for the duration of the trial
* able and willing to give informed consent and participate in the interventions
* willing to come to three sessions and visits
* willingness to be randomized to intervention or control group
Exclusion Criteria
* Type 1 DM and Type 2 DM with other end organ compromise (renal, retinal or other)
* Recent (within 6 months) cardiovascular event (MI or stroke)
* current symptoms of angina
* heart, renal, or liver disease (excluding kidney stone)
* cancer or active neoplasm (excluding skin cancers)
* hyperthyroidism
* mental conditions that would preclude full participation
* prior weight-loss (bariatric) surgery or plan for these procedures
* liposuction surgery in past 12 months or plan for these procedures
* recent weight loss in the past 3 months (\>20 lbs)
* use of prescription weight loss medication in 3 months prior to screening
* current use of medications for treatment of psychosis or manic-depressive illness
18 Years
70 Years
ALL
No
Sponsors
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PeaceHealth Laboratories
UNKNOWN
SK Telecom Americas, Inc.
INDUSTRY
Responsible Party
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PeaceHealth Laboratories
Principal Investigators
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Brigitte Piniewski, MD
Role: PRINCIPAL_INVESTIGATOR
PeaceHealth Laboratories
David Kil
Role: PRINCIPAL_INVESTIGATOR
SKTelecom Americas
Locations
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PeaceHealth Laboratories
Springfield, Oregon, United States
Countries
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Other Identifiers
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SKTA iWell 21
Identifier Type: -
Identifier Source: org_study_id
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