Clinical trial NCT01325376: PH iWell Study to Compare an Online Interactive Technology to Self-directed Care in Overweight or Obese Individuals
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Keywords: overweight
obesity
Lead sponsor: SK Telecom Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PeaceHealth Laboratories
First posted: 2011-03-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight loss from baseline
timeFrame: at 6 months
Secondary outcomes:
measure: Blood pressure change from baseline
timeFrame: at 3 months
measure: Triglyceride level change from baseline
timeFrame: at 3 months
measure: High density lipoprotein level change from baseline
timeFrame: at 3 months
measure: Physical activity adjustment from baseline
timeFrame: at 3 months
measure: Blood pressure change from baseline
timeFrame: at 6 months
measure: Triglyceride level change from baseline
timeFrame: at 6 months
measure: High density lipoprotein level change from baseline
timeFrame: at 6 months
measure: Physical activity adjustment from baseline
timeFrame: at 6months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: PeaceHealth Laboratories
state: Oregon
Study officials:
affiliation: PeaceHealth Laboratories
name: Brigitte Piniewski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SKTelecom Americas
name: David Kil
role: PRINCIPAL_INVESTIGATOR
References: