Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gail Daumit, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00902694
First received: May 13, 2009
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Weight loss [ Time Frame: 6 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902694

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Gail Daumit, Gail L. Daumit, MD, MHS, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00902694     History of Changes
Other Study ID Numbers: R01 MH080964, DAHBR 96-BHB, NIMH R01MH080964
Study First Received: May 13, 2009
Last Updated: December 7, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Serious Mental Illness
Weight Loss

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013