Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Johns Hopkins University291 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

291

Conditions

Overweight and Obesity

Interventions

ACHIEVE InterventionBEHAVIORAL

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

ControlOTHER

group health classes quarterly with topics not related to weight

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Prohealth

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change in Weight Loss in Kilograms (kg)

Change is from baseline to 6 months and baseline to 18 months

Time frame: 6 and 18 months

Secondary Outcomes

Minutes Cycled During Cycle Ergometry Testing

Minutes cycled during standardized cycle ergometry testing protocol; higher number of minutes cycled indicates better outcome.

Time frame: Baseline, 6 and 18 months

Change in Waist Circumference in Centimeters (cm)

Change in waist circumference in centimeters (cm) from baseline to 18 months

Time frame: Measured at baseline, 6 and 18 months

Change in Systolic and Diastolic Blood Pressure (mmHg)

Change in systolic and diastolic blood pressure (mmHg) from baseline to 18 months

Time frame: Measured at baseline, 6 and 18 months

Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)

Change in Lipids (total cholesterol, LDL, HDL and Triglyceride (mg/dL) from baseline to 18 months

Time frame: Measured at baseline, 6 and 18 months

Framingham Cardiovascular Risk Score

Higher score indicates greater cardiovascular risk. The score can range from 0-38 with higher scores yielding increased 10-year probability of stroke

Time frame: Measured at baseline, 6 and 18 months

Health Status as Measured by the SF-12

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.

Data from ClinicalTrials.gov

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