Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Not Applicable

Completed

• Conditions: Overweight and Obesity

• Registration Number: NCT00902694
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-04-01
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-13
• Study First Posted: 2009-05-15
• Primary Completion: 2012-09
• Study Completion: 2012-09-01
• Results First Submitted: 2025-06-18
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Results First Posted: 2025-07-30
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Weight Loss in Kilograms (kg)	6 and 18 months	Change is from baseline to 6 months and baseline to 18 months

Secondary Outcome Measures

Name	Time	Method
Minutes Cycled During Cycle Ergometry Testing	Baseline, 6 and 18 months	Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome.
Change in Systolic and Diastolic Blood Pressure (mmHg)	Measured at baseline, 6 and 18 months	Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months
Health Status as Measured by the SF-12	Baseline, 6 and 18 months	Health status reported for the SF-12 in two subscales-physical component summary (PCS) and the mental component summary (MCS). Subscale score ranges from 0-100 with higher scores indicating better physical or mental health.
Change in Waist Circumference in Centimeters (cm)	Measured at baseline, 6 and 18 months	Change in waist circumference in centimeters (cm) from baseline to 18 months
Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)	Measured at baseline, 6 and 18 months	Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months
Framingham Cardiovascular Risk Score	Measured at baseline, 6 and 18 months	Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke
Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D)	Baseline, 6 and 18 months	Total score range between 0 and 60, higher scores indicating more depressive symptoms

Trial Locations

Locations (1)

Prohealth; 🇺🇸 Baltimore, Maryland, United States