Reducing Weight and Diabetes Risk in an Underserved Population (STRIDE)

Completed · Phase 2

Conditions studied: Weight Loss, Diabetes Mellitus, Type 2, Psychotic Disorders

In brief

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 antipsychotic medications. We will examine the effectiveness of the intervention in 1. reducing weight and Body Mass Index; 2. reducing fasting insulin levels and increasing insulin sensitivity; and 3. reducing total cholesterol and LDL cholesterol.

Key facts

Study ID

NCT00790517

Run by

Kaiser Permanente

People needed

200

Starts

2009-06-01

Expected to finish

2014-12-01

Last updated by the study team

2015-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Cascadia Behavioral Healthcare — Portland, Oregon, United States
• Center for Health Research, Kaiser Permanente Northwest — Portland, Oregon, United States
• LifeWorks Northwest — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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