An interventional study of Premier Lifestyle Intervention with DASH Diet in Weight Loss, Diabetes Mellitus, Type 2 and Psychotic Disorders, sponsored by Kaiser Permanente. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
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
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).
1,766 studies on the registry are indexed under Weight Loss; 277 are open to participants now.
This study's enrollment of 200 is above the median of 73 across 1,496 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Premier Lifestyle Intervention with Dash Diet, adapted for populations with mental illnesses
Behavioral: Premier Lifestyle Intervention with DASH Diet
Usual care
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)
Also known as: DASH Diet
Body Mass Index
Time frame: 6, 12, 24 months
Weight
Time frame: 6, 12, 24 months
Insulin sensitivity
Time frame: 6, 12, 24 months
Fasting insulin levels
Time frame: 6, 12, 24 months
Cholesterol levels
Time frame: 6, 12, 24 months
Body Image
Time frame: 6, 12, 24 months
Antipsychotic Medication Adherence
Time frame: 6, 12, 24 months
Psychiatric Symptoms
Time frame: 6, 12, 24 months
Health-related self-efficacy
Time frame: 6, 12, 24 months
Social support for diet/weight loss
Time frame: 6, 12, 24 months
Quality of life using the WQLI assessment
Quality of life measures including: Life Satisfaction, Occupational Activities, Psychological Well Being, Physical Health, Social Relations, Economics, ADL/IADL, and Symptoms.
Time frame: 6, 12, 24 months
Health/functional status
Time frame: 6, 12, 24 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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