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ACHIEVE: Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Sponsor
Johns Hopkins University (Other)
Overall Status
Completed
CT.gov ID
NCT00902694
Collaborator
National Institute of Mental Health (NIMH) (NIH)
291
Enrollment
1
Location
2
Arms
53
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: ACHIEVE Intervention
  • Other: Control
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
291 participants
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
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Sep 1, 2012
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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
Other: 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

Outcome Measures

Primary Outcome Measures

  1. Weight loss [6 and 18 months]

Secondary Outcome Measures

  1. cycle ergometry testing/cardiorespiratory fitness [Measured at 6 and 18 months]

  2. Waist circumference [Measured at 6 and 18 months]

  3. Blood pressure [Measured at 6 and 18 months]

  4. Lipids [Measured at 6 and 18 months]

  5. Framingham cardiovascular risk score [Measured at 6 and 18 months]

  6. Health status [Measured at 6 and 18 months]

  7. Depression CES-D [Measured at 6 and 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gail Daumit, MD, MHS, Gail L. Daumit, MD, MHS, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00902694
Other Study ID Numbers:
  • R01MH080964
  • R01MH080964
  • DAHBR 96-BHB
  • NIMH R01MH080964
First Posted:
May 15, 2009
Last Update Posted:
Apr 25, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Gail Daumit, MD, MHS, Gail L. Daumit, MD, MHS, Johns Hopkins University
Serious Mental Illness
Weight Loss
Additional relevant MeSH terms:
Overweight

Study Results

No Results Posted as of Apr 25, 2014