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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Behavioral: Technology assisted health behavior
* Behavioral: Self directed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Self directed<br> | Behavioral: Self directed<br>* Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.<br>* Other names: Standard care;|
| Active Comparator: Technology assisted health behavior<br>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<br>* 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.<br>* Other names: DOIT Dynamic online interactive technology;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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overweight, obesity