PH iWell Study to Compare an Online Interactive Technology to Self-directed Care in Overweight or Obese Individuals

Obesity Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01325376
• Other study ID #: SKTA iWell 21
• Status: Active, not recruiting
• Phase: N/A
• First received: October 22, 2010
• Last updated: April 17, 2011
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: April 2011
• Source: SK Telecom Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	PeaceHealth Laboratories	Springfield	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
SK Telecom Americas, Inc.	PeaceHealth Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss from baseline		at 6 months	No
Secondary	Blood pressure change from baseline	Systolic blood pressure and diastolic blood pressure	at 3 months	No
Secondary	Triglyceride level change from baseline	Participants will have a venous draw to determine Triglyceride levels	at 3 months	No
Secondary	High density lipoprotein level change from baseline	Venous draw to determine high density lipoprotein levels	at 3 months	No
Secondary	Physical activity adjustment from baseline	Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm	at 3 months	No
Secondary	Blood pressure change from baseline		at 6 months	No
Secondary	Triglyceride level change from baseline		at 6 months	No
Secondary	High density lipoprotein level change from baseline		at 6 months	No
Secondary	Physical activity adjustment from baseline	Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm	at 6months	No