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| Sponsor: | Kaiser Permanente |
|---|---|
| Information provided by (Responsible Party): | Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT00790517 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Weight Loss Diabetes Mellitus, Type 2 Psychotic Disorders |
Behavioral: Premier Lifestyle Intervention with DASH Diet |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Reducing Weight and Diabetes Risk in an Underserved Population |
| Estimated Enrollment: | 280 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Premier Lifestyle Intervention with Dash Diet, adapted for populations with mental illnesses
|
Behavioral: Premier Lifestyle Intervention with DASH Diet
Comprehensive group lifestyle intervention focused on caloric restriction and increased moderate exercise using the DASH Diet. 6 months intensive intervention (weekly, group meetings) followed by 6 months of a less-intensive maintenance intervention (monthly group meetings with monthly telephone/e-mail consult)
Other Name: DASH Diet
|
|
No Intervention: 2
Usual care
|
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oregon | |
| Center for Health Research, Kaiser Permanente Northwest | |
| Portland, Oregon, United States, 97227-1110 | |
| Cascadia Behavioral Healthcare | |
| Portland, Oregon, United States, 97207 | |
| Principal Investigator: | Carla A Green, PhD, MPH | Center for Health Research, Kaiser Permanente Northwest |
More Information
| Responsible Party: | Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT00790517 History of Changes |
| Other Study ID Numbers: | R18DK076775 |
| Study First Received: | September 12, 2008 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Federal Government |
|
Weight loss Diabetes prevention Serious mental illness |
Antipsychotic medications Lifestyle intervention Antipsychotic Agents |
|
Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Psychotic Disorders Mental Disorders Weight Loss Signs and Symptoms Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Schizophrenia and Disorders with Psychotic Features Body Weight Changes Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
