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View Clinical Trial (Medical Research Study)
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Reducing Weight and Diabetes Risk in an Underserved Population (STRIDE) - NCT00790517-97227 (Clinical Trial 252916)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy252916.aspx
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| City: |
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Portland |
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State:
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OR |
| Zip Code: |
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97227 |
| Conditions: |
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Weight Loss - Diabetes Mellitus, Type 2 - Psychotic Disorders |
| Purpose: |
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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.
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| Study summary: |
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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. Individuals with serious mental illness represent a large underserved
population at greatly increased risk of obesity, diabetes, metabolic syndrome, and
subsequent early mortality. These risks are amplified by the antipsychotic agents that are
often prescribed to treat these mental conditions.
Although strong evidence indicates that lifestyle interventions are effective at reducing
weight and other diabetes risk factors in general populations, and pilot and feasibility
studies suggest that such interventions will be effective with individuals who have mental
illnesses, no large-scale translational trials have examined such interventions in this
population.
STRIDE is a randomized controlled trial to examine the effectiveness, in a mentally ill
population, of a lifestyle intervention previously shown to be effective for reducing weight
and diabetes risk factors. We target a group of individuals taking antipsychotic agents (n
= 280) who receive treatment in one of two clinical settings—a publicly funded behavioral
health care clinic and a non-profit private health plan. Counselors from each clinical
setting will be trained in the intervention and paired with study staff to deliver it,
increasing generalizability, and improving the probability of future adoption. The
intervention promotes moderate calorie reduction, dietary changes, and increased energy
expenditure, and is based on current clinical practice guidelines for treating obesity and
cardiovascular disease.
Specific aims test the hypotheses that the intervention is more effective than usual care
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. A
fourth aim explores effects of motivation, social support, and outcomes expectancies on
primary outcomes, and moderators of intervention effectiveness (ethnicity, gender, mental
illness diagnostic group, medication type, metabolic syndrome) on outcomes.
Implementation and process evaluations will assess the fidelity of intervention delivery,
evaluate its acceptability; identify components participants find most and least helpful;
identify barriers to, and facilitators of, lifestyle changes; and evaluate the effects of
the intervention on body image, psychiatric symptoms, adherence to antipsychotic
medications, quality of life, health-related self-efficacy, health, functional status, and
social support. Cost-effectiveness analyses will evaluate incremental costs of producing
change in each primary outcome (weight, BMI, fasting insulin levels, insulin sensitivity,
and cholesterol). |
| Criteria: |
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Inclusion Criteria:
1. age 18 and over
2. stable on antipsychotic agents >1 month
3. BMI in the range of 25-44.9 kg/m2
4. approved by primary care provider or psychiatrist for participation (based on mental
and physical health status)
5. able and willing to provide informed consent
6. access to telephone or e-mail (for maintenance phase)
Exclusion Criteria:
1. children under age 18
2. diagnosis of dementia
3. psychiatrist or primary care provider indication of any medical or psychiatric
contraindications for participating in a weight reduction/exercise program
4. cardiovascular event within the past 6 months (if more remote history, eligible with
primary care provider or psychiatrist approval)
5. history of bariatric surgery
6. cancer diagnosis or cancer treatment in the prior 2 years (except for non-melanoma
skin cancer)
7. currently pregnant or breastfeeding, or plan a pregnancy prior to the end of study
participation
8. mental health hospitalization in the 30 days prior to enrollment
9. planning on moving out of the area before the 24-month follow-up assessment
10. currently enrolled in a weight-reduction program |
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| Study is available at: |
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Center for Health Research, Kaiser Permanente Northwest
Portland, OR 97227
United States
Primary Contact:
Shannon L Janoff, MPH
Email: shannon.janoff@kpchr.org
Phone: 503-335-2400 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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