Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Overweight and Obesity Clinical Trial

— ACHIEVE  

Official title:

Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902694
• Other study ID #: R01MH080964
• Secondary ID: R01MH080964DAHBR
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: April 23, 2014
• Start date: April 2008
• Est. completion date: September 2012

Study information

• Verified date: April 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight and Obesity

Intervention

Behavioral:
• ACHIEVE Intervention
Group and individual weight loss counseling and group physical activity classes for 18 months

Other:
• Control
group health classes quarterly with topics not related to weight

Locations

Country	Name	City	State
United States	Prohealth	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss		6 and 18 months	No
Secondary	cycle ergometry testing/cardiorespiratory fitness		Measured at 6 and 18 months	No
Secondary	Waist circumference		Measured at 6 and 18 months	No
Secondary	Blood pressure		Measured at 6 and 18 months	No
Secondary	Lipids		Measured at 6 and 18 months	No
Secondary	Framingham cardiovascular risk score		Measured at 6 and 18 months	No
Secondary	Health status		Measured at 6 and 18 months	No
Secondary	Depression CES-D		Measured at 6 and 18 months	No