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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: Self directed; Behavioral: Technology assisted health behavior

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.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Springfield, Oregon, United States, 97477
      • PeaceHealth Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Self directed	Behavioral: Self directed; Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.; Other Names: Standard care
Active Comparator: 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.	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.; Other Names: DOIT Dynamic online interactive technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight loss from baseline	at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure change from baseline	Systolic blood pressure and diastolic blood pressure	at 3 months
Triglyceride level change from baseline	Participants will have a venous draw to determine Triglyceride levels	at 3 months
High density lipoprotein level change from baseline	Venous draw to determine high density lipoprotein levels	at 3 months
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
Blood pressure change from baseline		at 6 months
Triglyceride level change from baseline		at 6 months
High density lipoprotein level change from baseline		at 6 months
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

Collaborators and Investigators

• Sponsor: SK Telecom Americas, Inc.
• Collaborators: PeaceHealth Laboratories
• Investigators: Principal Investigator: Brigitte Piniewski, MD, PeaceHealth Laboratories; Principal Investigator: David Kil, SKTelecom Americas

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Estimate): April 19, 2011
• Last Update Submitted That Met QC Criteria: April 17, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: obesity; overweight
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: SKTA iWell 21