Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments technology assisted health behavior, self directed
Sponsor SK Telecom Americas, Inc.
Collaborator PeaceHealth Laboratories
Start date October 2010
End date October 2011
Trial size 500 participants
Trial identifier NCT01325376, SKTA iWell 21

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(No Intervention)
self directed Standard care
Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
(Active Comparator)
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 DOIT Dynamic online interactive technology
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.

Primary Outcomes

Measure
Weight loss from baseline
time frame: at 6 months

Secondary Outcomes

Measure
Blood pressure change from baseline
time frame: at 3 months
Triglyceride level change from baseline
time frame: at 3 months
High density lipoprotein level change from baseline
time frame: at 3 months
Physical activity adjustment from baseline
time frame: at 3 months
Blood pressure change from baseline
time frame: at 6 months
Triglyceride level change from baseline
time frame: at 6 months
High density lipoprotein level change from baseline
time frame: at 6 months
Physical activity adjustment from baseline
time frame: at 6months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title SKTA iWell21 Clinical Trial Protocol. This is a Randomized Control Trial of 500 Adult Participants Randomized to Two Arms: Control Arm: Self Directed Program (SDP), Intervention Arm: Dynamic On-line Interactive Technology (DOIT)
Principal investigator Brigitte Piniewski, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by SK Telecom Americas, Inc..