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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual Care | |
| Lifestyle Balance | Active Comparator | Behavioral Weight Loss Program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Weight Loss Program | Behavioral | Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weight | Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group. | Weekly/Monthly, up to 1 year |
| Change in Predicted Trajectory of Mean BMI Per GLMM Analysis | General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics. | 12 months |
| Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis | Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donna Ames, MD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17978266 | Background | 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. | |
| 26930534 | Result | 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. |
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122 volunteers met the inclusion criteria, signed the informed consent document, and completed the baseline screening assessments prior to randomization to study groups.
225 volunteers were screened November 2005 to August 2008 from Veterans Hospital psychiatric clinics in West Los Angeles, USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual Care control group |
| FG001 | Lifestyle Balance | Weight management education and counseling Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient
|
| FG002 | Changeover | Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants (14) randomized to Usual Care group who later elected to change over to Lifestyle Balance were excluded from statistical analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual Care control group |
| BG001 | Lifestyle Balance | Weight management education and counseling |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Weight | Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group. | All subjects who enrolled in this research program. Subjects were assessed weekly, when able. Since some were not able to do every weekly assessment, N varies weekly, and the weekly assessments below are the means of the number of subjects out of the total in the group who were assessed at that point. | Posted | Mean | Standard Deviation | Pounds | Weekly/Monthly, up to 1 year |
|
Four (4) years, between November 2005 and October 2009.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual Care control group |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest/rib pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
Limitations to our study were its single-site recruitment yielding subjects mostly male and all veterans, limiting of statistical power by control subjects allowed to join treatment group resulting in exclusion from data, and a high dropout rate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Donna Ames, Principal Investigator | Psychiatry Department at VA Greater Los Angeles Healthcare System | 310-478-3037 | donna.ames@va.gov |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D009765 | Obesity |
| D015430 | Weight Gain |
| D001523 | Mental Disorders |
| D012559 | Schizophrenia |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
|
| 12 months |
| 32687629 | Derived | 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. |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Not Noted |
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Living Situation | Number | participants |
|
| Marital Status | Number | participants |
|
| Education Level | Number | participants |
|
| Occupation | Number | participants |
|
| Medical Comorbidity | Number | participants |
|
| Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual | Number | participants |
|
| Antipsychotic (Weight Gain Risk) | Number | participants |
|
| Length of Psychiatric Illness | Mean | Standard Deviation | years |
|
| Age of Onset of Psychiatric Illness | Mean | Standard Deviation | years |
|
| Baseline Psychopathology Ratings | Brief Psychiatric Rating Scale: Symptom survey, score range 18 - 126, best to worst. Clinical Global Impression: Rates overall psychiatric symptom severity, scored 1-6, best to worst. Hamilton Depression Rating Scale: Score range 0 - 78, best to worst. Heinrichs Quality of Life Scale: Score range 0-132, worst to best. Self-Assessment of Illness Questionnaire: Rates mental health and weight, score range 32 - 128, best to worst. Antipsychotics Side-effects Checklist: Score range 17-34, worst to best. Motivational Interview to Assess Stage of Change: Scored 0-5, worst to best. | Mean | Standard Deviation | units on a scale |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Percent Body Fat | Mean | Standard Deviation | percentage |
|
| Framingham Hard Coronary Heart Disease | 10-year risk estimate of developing hard coronary heart disease | Mean | Standard Deviation | Percent |
|
| Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Laboratory Tests | Mean | Standard Deviation | mm/dL |
|
| Microalbumin/Creatinine | Mean | Standard Deviation | mgMA/gCrt |
|
|
|
|
| Primary | Change in Predicted Trajectory of Mean BMI Per GLMM Analysis | General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics. | Posted | Number | kg/m^2 | 12 months |
|
|
|
| Primary | Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis | Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics. | Posted | Number | Body Fat Percentage Change | 12 months |
|
|
|
| 8 |
| 48 |
| 1 |
| 48 |
| EG001 | Lifestyle Balance | Weight management education and counseling Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient
| 9 | 60 | 0 | 60 |
| EG002 | Changeover | Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request. | 1 | 14 | 1 | 14 |
| Bell's Palsy | Nervous system disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Staph Aureus Infection | Infections and infestations | Non-systematic Assessment |
|
| Prescription Medication Overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Malignant Pancreatic Mass | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Exacerbated Psychosis | Psychiatric disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Acute Pancreatitis | Endocrine disorders | Non-systematic Assessment |
|
| Syphilis Infection | Infections and infestations | Non-systematic Assessment |
|
| Neurotoxic Chemical Exposure | Nervous system disorders | Non-systematic Assessment | Neurological effect to wood varnish fumes |
|
| Exacerbated Mania | Psychiatric disorders | Non-systematic Assessment |
|
| Exacerbated Depresssion | Psychiatric disorders | Non-systematic Assessment |
|
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| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |