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

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-10-31

Brief Summary

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This is a six month lifestyle management study to compare the effects of iWell; a dynamic online interactive technology to a self-directed program in overweight or obese individuals.

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.

Detailed Description

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Optimal health behavior is difficult to sustain over extended periods. This study seeks to demonstrate that technology can be a low cost scaleable solution that will provide the user with sufficient customization and personalization through social networking approaches such that sustainability of optimal health behavior is realized.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Self directed

Group Type NO_INTERVENTION

Self directed

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Technology assisted health behavior

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Self directed

Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.

Intervention Type BEHAVIORAL

Other Intervention Names

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DOIT Dynamic online interactive technology Standard care

Eligibility Criteria

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Inclusion Criteria

* age 18-70 years old
* 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

* contraindication to weight loss (e.g., malignancy or other serious illness)
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PeaceHealth Laboratories

UNKNOWN

Sponsor Role collaborator

SK Telecom Americas, Inc.

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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United States

Other Identifiers

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SKTA iWell 21

Identifier Type: -

Identifier Source: org_study_id

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