Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2012-09-30

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.

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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.

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ACHIEVE Intervention

Group and individual weight counseling and group physical activity classes for 18 months.

Group Type EXPERIMENTAL

ACHIEVE Intervention

Intervention Type BEHAVIORAL

Group and individual weight loss counseling and group physical activity classes for 18 months

Control

Control arm receives group health classes quarterly with topics not related to weight

Group Type OTHER

Control

Intervention Type OTHER

group health classes quarterly with topics not related to weight

Interventions

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ACHIEVE Intervention

Group and individual weight loss counseling and group physical activity classes for 18 months

Intervention Type BEHAVIORAL

Control

group health classes quarterly with topics not related to weight

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No