Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation

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.

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.