Clinical trial NCT00902694: Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation
Official title: Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: Serious Mental Illness
Weight Loss
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-05-15
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Weight loss
timeFrame: 6 and 18 months
Secondary outcomes:
measure: cycle ergometry testing/cardiorespiratory fitness
timeFrame: Measured at 6 and 18 months
measure: Waist circumference
timeFrame: Measured at 6 and 18 months
measure: Blood pressure
timeFrame: Measured at 6 and 18 months
measure: Lipids
timeFrame: Measured at 6 and 18 months
measure: Framingham cardiovascular risk score
timeFrame: Measured at 6 and 18 months
measure: Health status
timeFrame: Measured at 6 and 18 months
measure: Depression CES-D
timeFrame: Measured at 6 and 18 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Prohealth
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Gail L. Daumit, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Casagrande SS, Jerome GJ, Dalcin AT, Dickerson FB, Anderson CA, Appel LJ, Charleston J, Crum RM, Young DR, Guallar E, Frick KD, Goldberg RW, Oefinger M, Finkelstein J, Gennusa JV 3rd, Fred-Omojole O, Campbell LM, Wang NY, Daumit GL. Randomized trial of achieving healthy lifestyles in psychiatric rehabilitation: the ACHIEVE trial. BMC Psychiatry. 2010 Dec 13;10:108. doi: 10.1186/1471-244X-10-108.
citation: Janssen EM, Jerome GJ, Dalcin AT, Gennusa JV 3rd, Goldsholl S, Frick KD, Wang NY, Appel LJ, Daumit GL. A cost analysis of implementing a behavioral weight loss intervention in community mental health settings: Results from the ACHIEVE trial. Obesity (Silver Spring). 2017 Jun;25(6):1006-1013. doi: 10.1002/oby.21836. Epub 2017 Apr 11.
citation: Daumit GL, Dickerson FB, Wang NY, Dalcin A, Jerome GJ, Anderson CA, Young DR, Frick KD, Yu A, Gennusa JV 3rd, Oefinger M, Crum RM, Charleston J, Casagrande SS, Guallar E, Goldberg RW, Campbell LM, Appel LJ. A behavioral weight-loss intervention in persons with serious mental illness. N Engl J Med. 2013 Apr 25;368(17):1594-602. doi: 10.1056/NEJMoa1214530. Epub 2013 Mar 21.