Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

NCT00902694 | Completed Results DMC

• 3 other identifiers: R01MH080964DAHBR 96-BHBNIMH R01MH080964
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

Serious Mental Illness; Weight Loss

Outcome Measures

Primary Outcomes (1)

• Change in Weight Loss in Kilograms (kg)

  Change is from baseline to 6 months and baseline to 18 months

  6 and 18 months

Secondary Outcomes (7)

• Minutes Cycled During Cycle Ergometry Testing

  Baseline, 6 and 18 months

• Change in Waist Circumference in Centimeters (cm)

  Measured at baseline, 6 and 18 months

• Change in Systolic and Diastolic Blood Pressure (mmHg)

  Measured at baseline, 6 and 18 months

• Change in Lipids (Total Cholesterol, LDL, HDL and Triglyceride (mg/dL)

  Measured at baseline, 6 and 18 months

• Framingham Cardiovascular Risk Score

  Measured at baseline, 6 and 18 months

Study Arms (2)

ACHIEVE Intervention

EXPERIMENTAL

Group and individual weight counseling and group physical activity classes for 18 months.

Behavioral: ACHIEVE Intervention

Control

OTHER

Control arm receives group health classes quarterly with topics not related to weight

Other: Control

Interventions

ACHIEVE Intervention BEHAVIORAL

Group and individual weight loss counseling and group physical activity classes for 18 months

ACHIEVE Intervention

Control OTHER

group health classes quarterly with topics not related to weight

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Prohealth

Baltimore, Maryland, 21207, United States

Location

Related Publications (3)

• 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.

  PMID: 21144025 BACKGROUND

• 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.

  PMID: 28398006 DERIVED

• 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.

  PMID: 23517118 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Gail Daumit, MD, MHS
• Organization: Johns Hopkins University School of Medicine

gdaumit@jhmi.edu

410-614-6460

Study Officials

• Gail L. Daumit, MD, MHS

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: April 1, 2008
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: July 30, 2025
• Results First Posted: July 30, 2025

Record last verified: 2025-07

Locations

US (1)