Clinical trial NCT00344500: Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications
Official title: Management of Antipsychotic Medication Associated Obesity
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: 2006-06-26
Enrollment: 122
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. The investigators use a program based on the American Diabetes Association's "Diabetes Prevention Program," and the investigators 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 West Los Angeles VA hospital.

Detailed description: Rationale: The focus of this project is to develop a strategy to combat medication associated weight gain, the most problematic side effect of the newer antipsychotic medications. Improvements in long-term health outcomes might then be expected to change quality of life, promote treatment adherence, rehabilitative potential, and decrease resource utilization.

Procedures:

Half of the patients will randomized to the behavioral weight loss program (Lifestyle Balance Program) and do the following: Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient Given a 7% weight loss goal Assisted in obtaining a 500 calorie reduction per day Asked to exercise for at least 30 min/day, at least 5 days a week Maintain weekly food and exercise diaries Be quizzed on their knowledge of healthy eating habits and nutrition

The other half of the patients will be randomized to "Usual Care" and will:

Receive pamphlets about Lifestyle Balance, starting exercise, and general nutritional information regarding food pyramids and the amount of calories in fast foods.

Be encouraged to exercise and eat a healthy diet Not receive classes on nutrition or exercise Be seen on the same schedule as the experimental group, in order to equalize contact time.

After six months, if patients in the "usual care group" wish to participate in the more rigorous behavioral weight loss program they will be given that opportunity.

Visits:

Time Line:

Each subject will be followed for one year. Healthy Lifestyles courses will take eight weeks to complete. Visits will be monthly for the remaining 12 months Enrollment: 120 patients Course of study: October 2005-October 2008

At Beginning and Termination:

Informed Consent (at start of study only) Psychiatric interviews and assessments Physical Examination Framingham risk assessment for cardiovascular disease Electrocardiogram Lipid Profile, fasting glucose, Hemoglobin A1C

At Each Visit:

Vitals, weight, waist circumference, BMI, and % Fat Food and exercise diaries will be reviewed

At Month One and Month Six:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram Psychiatric assessments

At Month Nine:

Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram

Clinical Care:

All patients will continue their clinical care with their current psychiatrist and general physician. Medications will not be manipulated for the purpose of this study.

Incentives:

The group participating in the behavioral intervention program will receive rewards for achieving weight loss goals and be given incentives such as a pedometer and Slimfast meal replacements.

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 the West Los Angeles 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
timeFrame: Weekly/Monthly, up to 1 year
measure: Change in Predicted Trajectory of Mean BMI Per GLMM Analysis
timeFrame: 12 months
measure: Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
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: Guzik LH, Wirshing DA. Behavioral weight loss classes for patients with severe mental illness. Psychiatr Serv. 2007 Nov;58(11):1498. doi: 10.1176/ps.2007.58.11.1498. No abstract available.
citation: Erickson ZD, Mena SJ, Pierre JM, Blum LH, Martin E, Hellemann GS, Aragaki DR, Firestone L, Lee C, Lee P, Kunkel CF, Ames D. Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial. J Clin Psychiatry. 2016 Feb;77(2):e183-9. doi: 10.4088/JCP.14m09552.
citation: Tully A, Smyth S, Conway Y, Geddes J, Devane D, Kelly JP, Jordan F. Interventions for the management of obesity in people with bipolar disorder. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013006. doi: 10.1002/14651858.CD013006.pub2.