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

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

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. 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).

Official Title
-----------------
Reducing Weight and Diabetes Risk in an Underserved Population

Conditions
-----------------
Weight Loss, Diabetes Mellitus, Type 2, Psychotic Disorders

Intervention / Treatment
-----------------
* Behavioral: Premier Lifestyle Intervention with DASH Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Premier Lifestyle Intervention with Dash Diet, adapted for populations with mental illnesses | Behavioral: Premier Lifestyle Intervention with DASH Diet<br>* 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)<br>* Other names: DASH Diet;|
| No Intervention: 2<br>Usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index |  | 6, 12, 24 months | 
| Weight |  | 6, 12, 24 months | 
| Insulin sensitivity |  | 6, 12, 24 months | 
| Fasting insulin levels |  | 6, 12, 24 months | 
| Cholesterol levels |  | 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Image |  | 6, 12, 24 months | 
| Antipsychotic Medication Adherence |  | 6, 12, 24 months | 
| Psychiatric Symptoms |  | 6, 12, 24 months | 
| Health-related self-efficacy |  | 6, 12, 24 months | 
| Social support for diet/weight loss |  | 6, 12, 24 months | 
| Quality of life |  | 6, 12, 24 months | 
| Health/functional status |  | 6, 12, 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, Diabetes prevention, Serious mental illness, Antipsychotic medications, Lifestyle intervention, Antipsychotic Agents