Clinical trial NCT01052714: Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2
Official title: Management of Antipsychotic Medication Associated Obesity - 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Weight Gain
Keywords: Antipsychotic
Bipolar
Diabetes
Mental Illness
Nutrition
Obesity
Schizoaffective
Schizophrenia
Weight Gain
Weight Loss
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-01-20
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This program aims to help Veterans who take antipsychotic medications lose weight. We use a program based on the American Diabetes Association's "Diabetes Prevention Program," and we have modified it to fit the lifestyles of people with mental illness. All participants are educated about nutrition and cutting down fat intake, how and when to exercise, and the causes of diabetes and how to prevent it. Participants must be Veterans who live within one hour of the Long Beach, West Los Angeles, Sepulveda, or West Los Angeles VA hospitals.


Eligibility criteria: Inclusion Criteria:

* Must be a Veteran
* Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness
* Age 18-70
* Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine
* Experienced weight gain since treatment with SGA's
* Inpatient or outpatient at Long Beach, West Los Angeles, Sepulveda, or Downtown VA
* Competent to sign informed consent

Exclusion Criteria:

* Have recently been diagnosed with schizophrenia (less than 1 year)
* Are pregnant or breast feeding a baby
* Have a medically unstable condition

Primary outcomes:
measure: Mean Weight Change Per Week From Baseline to Termination
timeFrame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
measure: Mean Waist Circumference Change Per Week From Baseline to Termination
timeFrame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
measure: Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination
timeFrame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
measure: Mean Serum Insulin Level Change Per Week From Baseline to Termination
timeFrame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Mean Triglycerides Level Change Per Week From Baseline to Termination
timeFrame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
timeFrame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
timeFrame: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.
measure: Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.
measure: Change in Mean Total Calories Consumed Per Week From Baseline to Termination
timeFrame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
measure: Change in Mean Empty Calories Consumed Per Week From Baseline to Termination
timeFrame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
measure: Change in Mean Total Exercise Time Per Week From Baseline to Termination
timeFrame: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
measure: Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
measure: WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
measure: WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
measure: WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
measure: WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
measure: Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
measure: Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
timeFrame: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System, Long Beach, CA
state: California
city: Sepulveda
country: United States
facility: VA Greater Los Angeles Healthcare System, Sepulveda, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Donna Ames, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kwan CL, Gelberg HAL, Rosen JA, Chamberlin V, Shah C, Nguyen C, Pierre JM, Erickson ZD, Mena SJ, King M Jr, Arnold I, Baker MR, Meyer HB, Ames D. Nutritional counseling for adults with severe mental illness: key lessons learned. J Acad Nutr Diet. 2014 Mar;114(3):369-374. doi: 10.1016/j.jand.2013.12.005. No abstract available.
citation: Gelberg HA, Kwan CL, Mena SJ, Erickson ZD, Baker MR, Chamberlin V, Nguyen C, Rosen JA, Shah C, Ames D. Meal replacements as a weight loss tool in a population with severe mental illness. Eat Behav. 2015 Dec;19:61-4. doi: 10.1016/j.eatbeh.2015.06.009. Epub 2015 Jul 2.
citation: Erickson ZD, Kwan CL, Gelberg HA, Arnold IY, Chamberlin V, Rosen JA, Shah C, Nguyen CT, Hellemann G, Aragaki DR, Kunkel CF, Lewis MM, Sachinvala N, Sonza PA, Pierre JM, Ames D. A Randomized, Controlled Multisite Study of Behavioral Interventions for Veterans with Mental Illness and Antipsychotic Medication-Associated Obesity. J Gen Intern Med. 2017 Apr;32(Suppl 1):32-39. doi: 10.1007/s11606-016-3960-3.
citation: Tessier JM, Erickson ZD, Meyer HB, Baker MR, Gelberg HA, Arnold IY, Kwan C, Chamberlin V, Rosen JA, Shah C, Hellemann G, Lewis MM, Nguyen C, Sachinvala N, Amrami B, Pierre JM, Ames D. Therapeutic Lifestyle Changes: Impact on Weight, Quality of Life, and Psychiatric Symptoms in Veterans With Mental Illness. Mil Med. 2017 Sep;182(9):e1738-e1744. doi: 10.7205/MILMED-D-16-00405.