Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Study Overview
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Brief Summary
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This study will determine whether a behavioral weight loss intervention including dietary counseling and exercise is effective in helping people with serious mental illnesses lose weight.

Detailed Description
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The objective of this study is to perform a randomized clinical trial (ACHIEVE) to definitively test the efficacy of an innovative, practical intervention to accomplish weight loss in overweight and obese persons with SMI. This multi-site trial will enroll consumers with SMI who attend ten psychiatric rehabilitation centers in Maryland and randomize participants to the ACHIEVE intervention or control. Intervention participants will receive group and individual weight loss counseling sessions and group physical activity classes. Co-primary outcomes will be change in weight from baseline to 6 and 18 months.

Official Title
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Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: ACHIEVE Intervention
* Other: Control


Participation Criteria
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Eligibility Criteria
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Age 18 and older; Overweight, defined by Body Mass Index at least 25.0 kg/m2; Able and willing to give informed consent and participate in the intervention; On the same psychiatric medications within the 30 days before baseline weight (dose changes allowed;) Able to attend at least 2 intervention sessions per week during initial 6-month phase; Exclusion criteria Contraindication to weight loss Receiving active cancer treatment (radiation/chemotherapy) Liver failure History of anorexia nervosa; Cardiovascular event (unstable angina, myocardial infarction) within previous 6 months; Prior or planned bariatric surgery; Use of prescription weight loss medication or over-the-counter orlistat within 3 months if participant does not agree to stop taking it; Twenty pound or greater weight loss in 3 months prior to baseline, as documented by staff measurement; Inability to walk to participate in exercise class; Pregnant or planning a pregnancy during study period. Nursing mothers would need approval from physician; Alcohol or substance use disorder either: 1) active and determined to be incompatible with participation in the intervention through discussion with program staff; or 2) new abstinence from alcohol or substance use disorder in past 30 days; Planning to leave rehabilitation center within 6 months or move out of geographic area within 18 months; Investigator judgment (e.g., for concerns over safety, adherence or follow-up); Weight greater than 400 pounds.

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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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACHIEVE Intervention<br>Group and individual weight counseling and group physical activity classes for 18 months. | Behavioral: ACHIEVE Intervention<br>* Group and individual weight loss counseling and group physical activity classes for 18 months<br>|
| Other: Control<br>Control arm receives group health classes quarterly with topics not related to weight | Other: Control<br>* group health classes quarterly with topics not related to weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss |  | 6 and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cycle ergometry testing/cardiorespiratory fitness |  | Measured at 6 and 18 months | 
| Waist circumference |  | Measured at 6 and 18 months | 
| Blood pressure |  | Measured at 6 and 18 months | 
| Lipids |  | Measured at 6 and 18 months | 
| Framingham cardiovascular risk score |  | Measured at 6 and 18 months | 
| Health status |  | Measured at 6 and 18 months | 
| Depression CES-D |  | Measured at 6 and 18 months | 

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