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

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Technology assisted health behavior
Self directed
Sponsored by
SK Telecom Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Overweight focused on measuring overweight, obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • PeaceHealth Laboratories

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Self directed

Technology assisted health behavior

Arm Description

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.

Outcomes

Primary Outcome Measures

Weight loss from baseline

Secondary Outcome Measures

Blood pressure change from baseline
Systolic blood pressure and diastolic blood pressure
Triglyceride level change from baseline
Participants will have a venous draw to determine Triglyceride levels
High density lipoprotein level change from baseline
Venous draw to determine high density lipoprotein levels
Physical activity adjustment from baseline
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm
Blood pressure change from baseline
Triglyceride level change from baseline
High density lipoprotein level change from baseline
Physical activity adjustment from baseline
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm

Full Information

First Posted
October 22, 2010
Last Updated
April 17, 2011
Sponsor
SK Telecom Americas, Inc.
Collaborators
PeaceHealth Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT01325376
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
SK Telecom Americas, Inc.
Collaborators
PeaceHealth Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
overweight, obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self directed
Arm Type
No Intervention
Arm Title
Technology assisted health behavior
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Technology assisted health behavior
Other Intervention Name(s)
DOIT Dynamic online interactive technology
Intervention Description
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
Intervention Name(s)
Self directed
Other Intervention Name(s)
Standard care
Intervention Description
Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
Primary Outcome Measure Information:
Title
Weight loss from baseline
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Blood pressure change from baseline
Description
Systolic blood pressure and diastolic blood pressure
Time Frame
at 3 months
Title
Triglyceride level change from baseline
Description
Participants will have a venous draw to determine Triglyceride levels
Time Frame
at 3 months
Title
High density lipoprotein level change from baseline
Description
Venous draw to determine high density lipoprotein levels
Time Frame
at 3 months
Title
Physical activity adjustment from baseline
Description
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm
Time Frame
at 3 months
Title
Blood pressure change from baseline
Time Frame
at 6 months
Title
Triglyceride level change from baseline
Time Frame
at 6 months
Title
High density lipoprotein level change from baseline
Time Frame
at 6 months
Title
Physical activity adjustment from baseline
Description
Standardized activity questionaire and activity monitoring device will be used to determine adjustments in activity for each arm
Time Frame
at 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Piniewski, MD
Organizational Affiliation
PeaceHealth Laboratories
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Kil
Organizational Affiliation
SKTelecom Americas
Official's Role
Principal Investigator
Facility Information:
Facility Name
PeaceHealth Laboratories
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States

12. IPD Sharing Statement

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

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