Status:
COMPLETED
Reducing Weight and Diabetes Risk in an Underserved Population (STRIDE)
Lead Sponsor:
Kaiser Permanente
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
LifeWorks Northwest
Conditions:
Weight Loss
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the effectiveness of a lifestyle intervention designed to reduce weight and diabetes risk in a population of individuals with mental illness who are also taking...
Detailed Description
Overweight and obesity are among the leading causes of preventable deaths in the US, primarily through their effects on Type II diabetes mellitus and other cardiovascular disease risk factors. Individ...
Eligibility Criteria
Inclusion
- age 18 and over
- stable on antipsychotic agents \>1 month
- BMI in the range of 25-44.9 kg/m2
- approved by primary care provider or psychiatrist for participation (based on mental and physical health status)
- able and willing to provide informed consent
- access to telephone or e-mail (for maintenance phase)
Exclusion
- children under age 18
- diagnosis of dementia
- psychiatrist or primary care provider indication of any medical or psychiatric contraindications for participating in a weight reduction/exercise program
- cardiovascular event within the past 6 months (if more remote history, eligible with primary care provider or psychiatrist approval)
- history of bariatric surgery
- cancer diagnosis or cancer treatment in the prior 2 years (except for non-melanoma skin cancer)
- currently pregnant or breastfeeding, or plan a pregnancy prior to the end of study participation
- mental health hospitalization in the 30 days prior to enrollment
- planning on moving out of the area before the 24-month follow-up assessment
- currently enrolled in a weight-reduction program
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00790517
Start Date
June 1 2009
End Date
December 1 2014
Last Update
March 17 2015
Active Locations (3)
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1
Cascadia Behavioral Healthcare
Portland, Oregon, United States, 97207
2
Center for Health Research, Kaiser Permanente Northwest
Portland, Oregon, United States, 97227-1110
3
LifeWorks Northwest
Portland, Oregon, United States, 97229