OverweightNCT01325376
PH iWell Study to Compare an Online Interactive Technology to Self-directed Care in Overweight or Obese Individuals
A study testing Technology assisted health behavior and Self directed in people with Overweight and Obesity, run by SK Telecom Americas, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Technology assisted health behavior and Self directed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- Technology assisted health behavior, Self directed
- Keywords
- overweight, obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technology assisted health behaviorBehavioural
Also called DOIT Dynamic online interactive technology
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 directedBehavioural
Also called Standard care
Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Self directed | No intervention | Not described Receives: Behavioral: Self directed |
| Technology assisted health behavior | Active comparator | 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. Receives: Behavioral: Technology assisted health behavior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss from baseline
Measured: at 6 months
Secondary outcomes (8)
Blood pressure change from baseline
Systolic blood pressure and diastolic blood pressure
Measured: at 3 months
Triglyceride level change from baseline
Participants will have a venous draw to determine Triglyceride levels
Measured: at 3 months
High density lipoprotein level change from baseline
Venous draw to determine high density lipoprotein levels
Measured: 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
Measured: at 3 months
Blood pressure change from baseline
Measured: at 6 months
Triglyceride level change from baseline
Measured: at 6 months
High density lipoprotein level change from baseline
Measured: 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
Measured: at 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionOct 2011 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SK Telecom Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PeaceHealth Laboratories
- Investigators
- Brigitte Piniewski, MD, Principal investigator, PeaceHealth LaboratoriesDavid Kil, Principal investigator, SKTelecom Americas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325376
- Sponsor's protocol ID
- SKTA iWell 21
- Status last verified
- Apr 2011
- First submitted
- 22 Oct 2010
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01325376
- Acronym / sponsor ID
- SKTA iWell 21
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- SK Telecom Americas, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PeaceHealth Laboratories
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 29 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self directed | No intervention | Behavioral: Self directed |
| Technology assisted health behavior | Active comparator | Behavioral: Technology assisted health behaviorThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Technology assisted health behaviorAlso: DOIT Dynamic online interactive technologyWeb-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. | Behavioural | Technology assisted health behavior |
| Self directedAlso: Standard careReceives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations. | Behavioural | Self directed |
Primary outcome
Weight loss from baseline
Time frame: at 6 months
8 secondary outcomes
Blood pressure change from baseline
Time frame: at 3 months
Triglyceride level change from baseline
Time frame: at 3 months
High density lipoprotein level change from baseline
Time frame: at 3 months
Physical activity adjustment from baseline
Time frame: at 3 months
Blood pressure change from baseline
Time frame: at 6 months
Triglyceride level change from baseline
Time frame: at 6 months
High density lipoprotein level change from baseline
Time frame: at 6 months
Physical activity adjustment from baseline
Time frame: at 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Piniewski, MD principal investigator
PeaceHealth Laboratories
David Kil principal investigator
SKTelecom Americas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Technology assisted health behavior and Self directed in people with Overweight and Obesity, run by SK Telecom Americas, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss from baseline (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2011.