Weight Management & Wellness for People With Psychiatric Disabilities

Study Overview
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Brief Summary
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The purpose of this study is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients.

Detailed Description
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Weight management is a serious issue for individuals with mental health conditions, especially those who are taking psychiatric medications. The latest estimates are that over half of individuals receiving community mental health services are overweight or obese. This project's objective is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients living and working in the community. It is an 8-week, recovery-oriented intervention that is co-led by a trained health educator and a certified mental health peer specialist. The study will take place at the UIC Department of Psychiatry in Chicago. Research participants will be recruited from the Department's outpatient clinics and other community programs, and randomly assigned to receive NEW-R along with services as usual or services as usual alone.

Official Title
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Weight Management & Wellness for People With Psychiatric Disabilities

Conditions
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Obesity, Mental Illness

Intervention / Treatment
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* Behavioral: NEW-R


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis with a mental health disorder Patient of outpatient program Age 18 or older Being overweight or obese defined as BMI>=25 Ability to understand spoken English Exclusion Criteria: Residing in a nursing home Cardiac event in past 6 months Past episode of anorexia or bulimia Pregnancy Diagnosis with a terminal illness expected to result in death within 1 year Active alcohol or substance abuse or dependence Inability to provide informed consent due to diagnosis of dementia or cognitive impairment Inability to understand spoken English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: NEW-R Intervention<br>NEW-R Intervention plus services as usual | Behavioral: NEW-R<br>* Eight session class on nutrition, physical activity, diet, and weight management<br>|
| No Intervention: Control<br>Services as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Competence Scale from Baseline to 8-months | Measures ability to stick with a weight management regimen and master new knowledge about diet and exercise. This 4-item scale using a 7-point Likert response format ranging from not at all true to very true. The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome. | Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3 | 
| Change in Health Promoting Lifestyle Profile from Baseline to 8-months | Measure of health promoting behavior. This is a 26-item scale with a 4-point Likert response format ranging from never to routinely. Minimum value for this scale is 26 and the maximum is 104, with higher scores indicating a better outcome. The dimensions include nutrition, spirituality, and physical activity. | Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-months | Self perceived health management ability. This 7-item scale uses a 5-point Likert response format ranging from not at all to completely. The minimum value is 7 and the maximum is 35, with higher scores indicating a better outcome. | Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3 | 
| Change in Weight from Baseline to 8-months | Weight in pounds | Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Weight Management, Serious Mental Illness