Status:
COMPLETED
Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Overweight and Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00902694
Start Date
April 1 2008
End Date
September 1 2012
Last Update
July 30 2025
Active Locations (1)
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1
Prohealth
Baltimore, Maryland, United States, 21207