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

SK Telecom Americas

Status: Unknown

Conditions: Overweight; Obesity

Treatments: Behavioral: Technology assisted health behavior; Behavioral: Self directed

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01325376

SKTA iWell 21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Self directed

No Intervention group

Treatment:

Behavioral: Self directed

Technology assisted health behavior

Active Comparator group

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.

Treatment:

Behavioral: Technology assisted health behavior