Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Not Applicable

Completed

• Conditions: Overweight and Obesity
• Interventions: Behavioral: ACHIEVE Intervention; Other: Control

• 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
• 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
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-23
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACHIEVE Intervention	ACHIEVE Intervention	Group and individual weight counseling and group physical activity classes for 18 months.
Control	Control	Control arm receives group health classes quarterly with topics not related to weight

Primary Outcome Measures

Name	Time	Method
Weight loss	6 and 18 months

Secondary Outcome Measures

Name	Time	Method
Framingham cardiovascular risk score	Measured at 6 and 18 months
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
Health status	Measured at 6 and 18 months
Lipids	Measured at 6 and 18 months
Depression CES-D	Measured at 6 and 18 months

Trial Locations

Locations (1)

Prohealth; 🇺🇸 Baltimore, Maryland, United States