N/A
N=291
Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation
Overweight and Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00902694 ↗Enrolled (actual)
291
Serious AEs
30.6%
Results posted
Jul 2025
Primary outcome: Primary: Change in Weight Loss in Kilograms (kg) — -1.8; -0.3; -3.4; -0.2 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ACHIEVE Intervention (Behavioral); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Weight Loss in Kilograms (kg) |
-1.8; -0.3; -3.4; -0.2 | — |
| SECONDARY Minutes Cycled During Cycle Ergometry Testing |
6.95; 6.86; 7.12; 6.91; 7.19; 6.79 | — |
| SECONDARY Change in Waist Circumference in Centimeters (cm) |
-1.5; 0.5; -2.2; -1.9 | — |
| SECONDARY Change in Systolic and Diastolic Blood Pressure (mmHg) |
-2.5; -2.1; -0.7; -0.9; -1.1; -2.7 | — |
| SECONDARY Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL) |
-4.8; -1.9; -5.6; -0.3; -3.8; -2.5 | — |
| SECONDARY Framingham Cardiovascular Risk Score |
0.0999; 0.0989; 0.1029; 0.0991; 0.1035; 0.0978 | — |
| SECONDARY Health Status as Measured by the SF-12 |
45.1; 43.4; 45.5; 43.8; 46.2; 44.4 | — |
| SECONDARY Depression Assessed by Center for Epidemiologic Studies Depression Scale (CES-D) |
19.7; 20.1; 18.7; 20.9; 18.7; 19.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00902694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.