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

Primary Purpose

Overweight and Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACHIEVE Intervention
Control
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Serious Mental Illness, Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Prohealth

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ACHIEVE Intervention

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Weight loss

Secondary Outcome Measures

cycle ergometry testing/cardiorespiratory fitness
Waist circumference
Blood pressure
Lipids
Framingham cardiovascular risk score
Health status
Depression CES-D

Full Information

First Posted
May 13, 2009
Last Updated
April 23, 2014
Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00902694
Brief Title
Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation
Acronym
ACHIEVE
Official Title
Randomized Trial Of Achieving Healthy Lifestyles In Psychiatric Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity
Keywords
Serious Mental Illness, Weight Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACHIEVE Intervention
Arm Type
Experimental
Arm Description
Group and individual weight counseling and group physical activity classes for 18 months.
Arm Title
Control
Arm Type
Other
Arm Description
Control arm receives group health classes quarterly with topics not related to weight
Intervention Type
Behavioral
Intervention Name(s)
ACHIEVE Intervention
Intervention Description
Group and individual weight loss counseling and group physical activity classes for 18 months
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
group health classes quarterly with topics not related to weight
Primary Outcome Measure Information:
Title
Weight loss
Time Frame
6 and 18 months
Secondary Outcome Measure Information:
Title
cycle ergometry testing/cardiorespiratory fitness
Time Frame
Measured at 6 and 18 months
Title
Waist circumference
Time Frame
Measured at 6 and 18 months
Title
Blood pressure
Time Frame
Measured at 6 and 18 months
Title
Lipids
Time Frame
Measured at 6 and 18 months
Title
Framingham cardiovascular risk score
Time Frame
Measured at 6 and 18 months
Title
Health status
Time Frame
Measured at 6 and 18 months
Title
Depression CES-D
Time Frame
Measured at 6 and 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail L. Daumit, MD, MHS
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prohealth
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21144025
Citation
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.
Results Reference
background
PubMed Identifier
28398006
Citation
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.
Results Reference
derived
PubMed Identifier
23517118
Citation
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.
Results Reference
derived

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Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

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