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Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation (ACHIEVE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902694
First Posted: May 15, 2009
Last Update Posted: April 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Gail Daumit, MD, MHS, Johns Hopkins University
  Purpose
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.

Condition Intervention
Overweight and Obesity Behavioral: ACHIEVE Intervention Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation

Resource links provided by NLM:


Further study details as provided by Gail Daumit, MD, MHS, Johns Hopkins University:

Primary Outcome Measures:
  • Weight loss [ Time Frame: 6 and 18 months ]

Secondary Outcome Measures:
  • cycle ergometry testing/cardiorespiratory fitness [ Time Frame: Measured at 6 and 18 months ]
  • Waist circumference [ Time Frame: Measured at 6 and 18 months ]
  • Blood pressure [ Time Frame: Measured at 6 and 18 months ]
  • Lipids [ Time Frame: Measured at 6 and 18 months ]
  • Framingham cardiovascular risk score [ Time Frame: Measured at 6 and 18 months ]
  • Health status [ Time Frame: Measured at 6 and 18 months ]
  • Depression CES-D [ Time Frame: Measured at 6 and 18 months ]

Enrollment: 291
Study Start Date: April 2008
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACHIEVE Intervention
Group and individual weight counseling and group physical activity classes for 18 months.
Behavioral: ACHIEVE Intervention
Group and individual weight loss counseling and group physical activity classes for 18 months
Control
Control arm receives group health classes quarterly with topics not related to weight
Other: Control
group health classes quarterly with topics not related to 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902694


Locations
United States, Maryland
Prohealth
Baltimore, Maryland, United States, 21207
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Gail L. Daumit, MD, MHS Johns Hopkins School of Medicine
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gail Daumit, MD, MHS, Gail L. Daumit, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00902694     History of Changes
Other Study ID Numbers: R01MH080964 ( U.S. NIH Grant/Contract )
DAHBR 96-BHB
NIMH R01MH080964
First Submitted: May 13, 2009
First Posted: May 15, 2009
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by Gail Daumit, MD, MHS, Johns Hopkins University:
Serious Mental Illness
Weight Loss

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms