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The goal of this project, which has not changed, is to evaluate the statewide implementation of a two-component intervention (health promotion plus academic detailing) with respect to consumer outcomes and changes in provider prescribing. The intervention, called In SHAPE, is delivered to people with serious mental illness (SMI) by two community mental health clinics (CMHCs). These CMHCs are compared to two CMHCs delivering usual-care to individuals with SMI. The specific aims of this study are:
Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This natural experiment presents an unprecedented opportunity to evaluate the public health impact of a statewide health-promotion program for persons with SMI, a potential model for reducing early mortality among persons with SMI served by state mental-health systems nationwide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In SHAPE | Experimental | In SHAPE is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness. |
|
| Usual-Care Control | No Intervention | Usual-care consumers agreed to delay participation in In SHAPE for 12 months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In SHAPE | Behavioral | In SHAPE is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in exercise capacity | Change in exercise capacity measured by the 6-minute walk test. | baseline, 6-, 12-, and 24-months |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported physical activity | Change in self-reported physical activity measured with International Physical Activity Questionnaire (IPAQ) | baseline, 6-, 12-, and 24-months |
| Change in dietary behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Bartels, MD, MS | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Central Behavioral Health | Lebanon | New Hampshire | 03766 | United States | ||
| Mental Health Center of Greater Manchester |
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Change in dietary behaviors measured with the Block Food Frequency Questionnaire (FFQ)21 and the Questionnaire on Eating and Weight Patterns (QEWP).
| baseline, 6-, 12-, and 24-months |
| Change in stage of change | Change in stage of change measured with the Weight Loss Behavior-Stage of Change Scale (WLB-SOC) 23 to assess stage of change for engaging in healthy eating and exercise behaviors. | baseline, 6-, 12-, and 24-months |
| Change in eating behavior | Change in eating behavior measured with the Dutch Eating Behavior Questionnaire which includes 13 questions assessing emotional eating and 10 questions related to external eating behaviors | baseline, 6-, 12-, and 24-months |
| Change in physical measurement | Including height, weight, pulse, CO2 level, lung capacity from spirometer, variables from impedance measure such as percentage of body fat and percentage of lean muscle mass, cholesterol and triglyceride levels from finger stick (cholesterol data for data points that have already passed will be collected from participants' clinic and hospital records), waist circumference: BMI derived from height and weight. | baseline, 6-, 12-, and 24-months |
| Change in smoking and substance use | Change in smoking and substance use measured by questions developed for R01DA021245, "Smoking Cessation and Smoking Relapse Prevention in Patients with Schizophrenia," and questions from the "Quit Smoking Decision Aid"( developed by Ferron and Brunette, CPHS # 180) to ascertain smoking frequency, quantity, and cessation attempts | baseline, 6-, 12-, and 24-months |
| Change in psychological functioning (depression, negative symptoms, and self-efficacy). | Change in psychological functioning measured by the Center for Epidemiologic Studies Depression Scale,Scale to Assess Negative Symptoms,16 and the Self-Rated Abilities for Health Practices Scale will be used to assess these constructs. | baseline, 6-, 12-, and 24-months |
| Change in social functioning | Change in social functioning measured by the Social Network Questionnaire and Lehman Social Contact Scale. | baseline, 6-, 12-, and 24-months |
| Change in family contact | Change in family contact measured by the Revised Family Contact Questionnaire. | baseline, 6-, 12-, and 24-months |
| Change in social support and eating habits | Change in the impact of social support on eating habits measured by the Social Support and Eating Habits Survey | baseline, 6-, 12-, and 24-months |
| Change in social support and exercise | Change in the impact of social support on exercise behaviors measured by the Social Support and Exercise Survey | baseline, 6-, 12-, and 24-months |
| Change in comorbid medical illness | Change in comorbid medical illness measured using a medical problems list. | baseline, 6-, 12-, and 24-months |
| Change in medications | Change in medications measured by gathering information from participants about type, dose, and frequency of all prescribed medications. | baseline, 6-, 12-, and 24-months |
| Change in service use | Measured change in service use based on a measured designed for the In SHAPE studies to collect self-reported use of emergency services and hospitalizations. | baseline, 6-, 12-, and 24-months |
| Manchester |
| New Hampshire |
| 03103 |
| United States |
| Greater Nashua Mental Health Center at Community Council | Nashua | New Hampshire | 03060 | United States |
| Center for Life Management | Salem | New Hampshire | 03079 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D011618 | Psychotic Disorders |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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