Examining an Exercise and Nutrition Program for Reducing Weight in People With Severe Mental Illnesses (The ACHIEVE Study) - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00902694

Purpose

This study will determine whether a nutrition and exercise program is effective in helping people with severe mental illnesses lose weight.

Condition	Intervention	Phase
Obesity	Behavioral: ACHIEVE Program Other: Control	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title:	Randomized Trial Of Achieving Healthy Lifestyles In Psych Rehabilitation

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Mental Disorders Obesity Rehabilitation Weight Control

U.S. FDA Resources

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

Primary Outcome Measures:

Weight loss [ Time Frame: Measured at 6 and 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	320
Study Start Date:	April 2008
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will take part in an exercise and nutrition program.	Behavioral: ACHIEVE Program Group and individual weight loss counseling and group physical activity classes for 18 months
Active Comparator: 2 Participants will receive an individual session with a nutritionist and access to periodic exercise classes.	Other: Control Group health classes every 3 months for 18 months

Detailed Description:

Obesity and being overweight are prevalent states in people with severe mental illnesses (SMIs). These weight conditions may contribute to premature cardiovascular disease and the 20% shortened life expectancy of people with SMIs. Physical activity and dietary changes have proven effective in reducing weight in people without SMIs who are obese and overweight. This study will determine whether an exercise and nutrition program for people with SMIs results in weight loss and maintenance of any weight loss.

Participation in this study will last 18 months, with follow-up visits continuing for 24 months. Participants will be randomly assigned to receive either the ACHIEVE intervention—an exercise and nutrition program adapted for people with SMIs—or usual care as part of a control group. Those receiving the ACHIEVE intervention will complete three types of activities: weight management groups, in which participants meet in groups with a nutritionist to receive information and motivation and to set goals; individual sessions with a nutritionist for further counseling; and group physical activity, in which they will perform aerobic activity. For the first 6 months, participants will complete weight management group sessions weekly, individual sessions monthly, and group activity sessions three times per week. For the next 12 months, participants will complete weight management group sessions monthly, individual sessions every 2 months, and group activity sessions up to three times per week. Participants will also weigh in to check their weight weekly. Participants in the control group will complete an individual session with a nutritionist at the beginning of the study and will be allowed to participate in group health classes several times per year.

All participants will complete study assessments at baseline and after 6 and 18 months. These assessments will include a blood draw; measurements of weight, waist circumference, and blood pressure; a bicycle test; 7 days of activity monitoring through an accelerometry device; and questionnaires on nutrition, exercise, mood, and quality of life. Additional weighing sessions will occur at 12 and 24 months after study enrollment.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Overweight, defined as a body mass index (BMI) greater than or equal to 25 kg/m2
Taking the same psychotropic medications for 90 days
Able to attend two intervention sessions per week

Exclusion Criteria:

Contraindication to weight loss, such as active cancer treatment, liver failure, or anorexia
Presence of a cardiovascular event within the past 6 months
Inability to walk to participate in exercise
Active alcohol or substance use disorder
Planning to leave rehabilitation center within 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00902694

Locations

United States, Maryland
Prohealth	Recruiting
Baltimore, Maryland, United States, 21207
Contact: Leslie M. Campbell 410-285-8085 lcampbel@jhmi.edu
Contact: Gail L. Daumit, MD, MHS 410-614-6460 gdaumit1@jhmi.edu
Principal Investigator: Gail L. Daumit, MD, MHS

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Gail L. Daumit, MD, MHS

Johns Hopkins School of Medicine

More Information

No publications provided by National Institute of Mental Health (NIMH)

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

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.

Responsible Party:	Gail L. Daumit, Johns Hopkins School of Medicine
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:	June 25, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Severe Mental Illness
Weight Loss

Additional relevant MeSH terms:

Mental Disorders
Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012