Reducing Weight and Diabetes Risk in an Underserved Population (STRIDE)
This study is ongoing, but not recruiting participants.
Sponsor:
Kaiser Permanente
Collaborators:
Cascadia Behavioral Healthcare
LifeWorks Northwest
Oregon Health and Science University
University of Medicine and Dentistry New Jersey
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT00866372
First received: March 19, 2009
Last updated: February 28, 2012
Last verified: February 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 19, 2009 | ||||
| Last Updated Date | February 28, 2012 | ||||
| Start Date ICMJE | October 2009 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
reducing weight and BMI [ Time Frame: Baseline, 6-, 12-, and 24-months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
reducing weight and BMI [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00866372 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Reducing Weight and Diabetes Risk in an Underserved Population | ||||
| Official Title ICMJE | Reducing Weight and Diabetes Risk in an Underserved Population | ||||
| Brief Summary | This study will examine whether a lifestyle change program to reduce weight and diabetes risk factors will be effective among people with serious mental illnesses. If the results are positive, it could help people with mental illness improve their health and reduce their diabetes risk. |
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| Detailed Description | |||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | |||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Life style Intervention
Translational randomized controlled trial assessing the effectiveness of a known efficacious and comprehensive lifestyle intervention in an underserved mentally ill population at high risk for obesity and diabetes. |
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| Study Arm (s) | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 280 | ||||
| Estimated Completion Date | March 2013 | ||||
| Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00866372 | ||||
| Other Study ID Numbers ICMJE | R18 DK76775, R18DK076775 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Kaiser Permanente | ||||
| Study Sponsor ICMJE | Kaiser Permanente | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Kaiser Permanente | ||||
| Verification Date | February 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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