Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH078052 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.
The three specific aims of this study are to:
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 study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people with SMI.
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| Fitness Club Membership | Active Comparator | Fitness club membership with education in using the exercise equipment. |
|
| 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 Weight | Change in weight over time was measured at baseline, 3-, 6-, 9-, 12-, and 18-months. Measures were weight (kg) and body mass index (kg/m2). | Baseline, 3-, 6-, 9-, 12-, and 18-months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Behaviors | Change in dietary behaviors was assessed over time using a scale adapted from the Stages of Change Modified Motivational Interviewing instrument focused on dietary behaviors and physical activity. | Baseline, 6-, 12-, and 18-months |
| Change in Dietary Intake |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen J Bartels, MD, MS | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baycove Human Services | Boston | Massachusetts | 02114 | United States | ||
| Massachusetts Mental Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28240625 | Derived | Naslund JA, Aschbrenner KA, Pratt SI, Lohman MC, Scherer EA, McHugo GJ, Marsch LA, Unutzer J, Bartels SJ. Association Between Cardiovascular Risk and Depressive Symptoms Among People With Serious Mental Illness. J Nerv Ment Dis. 2017 Aug;205(8):634-640. doi: 10.1097/NMD.0000000000000669. | |
| 25827032 | Derived | Bartels SJ, Pratt SI, Aschbrenner KA, Barre LK, Naslund JA, Wolfe R, Xie H, McHugo GJ, Jimenez DE, Jue K, Feldman J, Bird BL. Pragmatic replication trial of health promotion coaching for obesity in serious mental illness and maintenance of outcomes. Am J Psychiatry. 2015 Apr;172(4):344-52. doi: 10.1176/appi.ajp.2014.14030357. Epub 2014 Dec 12. |
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fitness Club Membership | Behavioral | Fitness club membership with education in using the exercise equipment. |
|
Change in dietary intake over time was assessed using the Brief Block Food Frequency Questionnaire and nutrient analysis was conducted with NutritionQuest using a nutrient database developed from the USDA Nutrient Database for Standard Reference. |
| Baseline, 6-, 12-, and 18-months |
| Change in Serum lipids | Change in serum lipids over time was measured using the CardioChek PA Analyzer, a hand-held dual testing system that produces values for total cholesterol, LDL, HDL, and triglycerides using a multi-panel test strip and a single drop of blood acquired with a finger prick. | Baseline, 6-, 12-, and 18-months |
| Change in Blood Pressure | Change in systolic and diastolic blood pressure over time was measured using a blood pressure cuff. | Baseline, 6-, 12-, and 18-months |
| Change in Cardiorespiratory Fitness | Change in cardiorespiratory fitness over time was measured using the 6 Minute Walk Test (distance in m that a participant can walk in 6 minutes). | Baseline, 6-, 12-, and 18-months |
| Change in Physical Activity | Change in self-reported physical activity was measured over time using the short-form International Physical Activity Questionnaire (IPAQ). | Baseline, 3-, 6-, 9-, 12-, and 18-months |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Vinfen | Cambridge | Massachusetts | 02141-1001 | United States |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |