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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gail Daumit, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00902694
First received: May 13, 2009
Last updated: April 23, 2014
Last verified: April 2014

May 13, 2009
April 23, 2014
April 2008
September 2012   (final data collection date for primary outcome measure)
Weight loss [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]
Weight loss [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00902694 on ClinicalTrials.gov Archive Site
  • cycle ergometry testing/cardiorespiratory fitness [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Framingham cardiovascular risk score [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Health status [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Depression CES-D [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Moderate physical activity [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Lipids [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Framingham cardiovascular risk score [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Health status [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Depression [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]
  • Weight loss at follow-up [ Time Frame: Measured at 12 and 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation
Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overweight and Obesity
  • 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
  • Experimental: ACHIEVE Intervention
    Group and individual weight counseling and group physical activity classes for 18 months.
    Intervention: Behavioral: ACHIEVE Intervention
  • Control
    Control arm receives group health classes quarterly with topics not related to weight
    Intervention: Other: Control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
291
September 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00902694
R01 MH080964, R01MH080964, DAHBR 96-BHB, NIMH R01MH080964
Yes
Gail Daumit, MD, MHS, Johns Hopkins University
Johns Hopkins University
National Institute of Mental Health (NIMH)
Principal Investigator: Gail L. Daumit, MD, MHS Johns Hopkins School of Medicine
Johns Hopkins University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP