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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Control group with time-matched study visits | |
| Lifestyle Balance | Active Comparator | Weight management group education and individual counseling |
|
| Usual Care then Lifestyle Balance | Other | Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Balance | Behavioral | Patients assigned 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 - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Weight Change Per Week From Baseline to Termination | Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
| Mean Waist Circumference Change Per Week From Baseline to Termination | Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
| Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination | Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
| Mean Serum Insulin Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
| Mean Triglycerides Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
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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 Long Beach Healthcare System, Long Beach, CA | Long Beach | California | 90822 | United States | ||
| VA Greater Los Angeles Healthcare System, Sepulveda, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24534370 | Background | 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. | |
| 26172565 |
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Participants were terminated from study prior to randomization to study groups due to screen failure or withdrawal from study during the baseline assessment period.
Recruitment from outpatient mental health clinics at four southern California VA facilities occurred from September 2010 through March 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Control group with time-matched study visits |
| FG001 | Lifestyle Balance | Weight management group education and individual counseling Patients randomized to the Lifestyle Balance Program will do the following:
|
| FG002 | Usual Care Then Lifestyle Balance | Participants originally randomized to Usual Care, allowed to change over to Lifestyle Balance at month 6 per their request. Patients randomized to the Lifestyle Balance Program will do the following:
|
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Control group with time-matched study visits Includes 17 participants who would later join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. |
| BG001 | Lifestyle Balance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Change Per Week From Baseline to Termination | Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Pounds per week | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
|
During 52-week period from participant randomization to termination.
17 participants in "Usual Care then Lifestyle Balance" group are included in both Usual Care and Lifestyle Balance arms, as they were exposed to both interventions. Events for these participants are reported per intervention, tallied under the intervention they were in at the time the event occurred.
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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 | Control group with time-matched study visits | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death NOS | General disorders | CTCAE (4.0) | Non-systematic Assessment | Caregiver-reported death of subject |
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| 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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2014 | Sep 6, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2011 | Sep 6, 2017 | ICF_001.pdf |
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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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|
|
| Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
| Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
| Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination | Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared. | Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months. |
| Change in Mean Total Calories Consumed Per Week From Baseline to Termination | Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
| Change in Mean Empty Calories Consumed Per Week From Baseline to Termination | Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
| Change in Mean Total Exercise Time Per Week From Baseline to Termination | Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared. | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
| Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination | Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
| Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination | Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
| Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination | Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared. | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
| Sepulveda |
| California |
| 91343 |
| United States |
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073 | United States |
| 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. |
| 28271424 | Result | 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. |
| 28885930 | Derived | 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. |
| Lost to Follow-up |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
Weight management group education and individual counseling
Lifestyle Balance: Patients assigned 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 - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Living Situation | Self-selected description of living situation. | One Usual Care subject declined to respond. | Count of Participants | Participants |
|
| Education | Self-selected description of highest education level reached. | One Usual Care subject declined to respond. | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Job Status | Self-selected description of employment situation. Unpaid=homemaker, student, volunteer; None=retired, disabled. | One Usual Care and one Lifestyle Balance subject declined to respond. | Count of Participants | Participants |
|
| Diagnosis | Based on Diagnostic and Statistical Manual-IV criteria | Count of Participants | Participants |
|
| Antipsychotic (Weight Gain Risk) | Seven Usual Care and seven Lifestyle Balance participants were documented to be on Multiple antipsychotic medications. They are reported in the "Multiple" category, and also contribute to the tally of each of those antipsychotic medications. | Count of Participants | Participants |
|
| Length of Illness | Mean | Standard Deviation | years |
|
| Age at Onset | Mean | Standard Deviation | years |
|
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|
|
| Primary | Mean Waist Circumference Change Per Week From Baseline to Termination | Participants' waist circumference was measured at each visit by study personnel using a measuring tape, and the study groups' average waist circumference changes per week were compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Inches per week | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
|
|
|
|
| Primary | Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination | Study personnel calculated each participant's BMI at each visit using their weight measurement taken at that visit and their height measurement taken at baseline. The study groups' average BMI changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Units on a scale per week | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
|
|
|
|
| Primary | Mean Serum Insulin Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Pmol/L per week | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
|
|
|
|
| Primary | Mean Triglycerides Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Mg/dL per week | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
|
|
|
|
| Primary | Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Mg/dL per week | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
|
|
|
|
| Primary | Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Mg/dL per week | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. |
|
|
|
|
| Primary | Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination | Quiz of information covered during Lifestyle Balance classes, score range 0 - 30, worst to best. The study groups' average score changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| Primary | Change in Mean Total Calories Consumed Per Week From Baseline to Termination | Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total calories consumed per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Calories per week | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
|
|
|
|
| Primary | Change in Mean Empty Calories Consumed Per Week From Baseline to Termination | Caloric intake assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in empty calories consumed per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Calories per week | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
|
|
|
|
| Primary | Change in Mean Total Exercise Time Per Week From Baseline to Termination | Minutes exercised assessed by dietitians using participant-recorded weekly food and exercise journals. The study groups' average change in total minutes exercised per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Minutes per week | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. |
|
|
|
|
| Primary | Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination | Self-reported survey of respondents' feelings about changing their weight problem. Total score is also called the Readiness Score, ranging from -2 to +14 (worse to better), calculated by subtracting the mean from the precontemplation responses from the summation of the means of responses to contemplation, action, and the struggling to maintain items. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| Primary | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' physical health, score range 7-35, worst to best. The study groups' average subscore changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| Primary | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' psychological health, score range 6-30, worst to best. The study groups' average subscore changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| Primary | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' social relationships, score range 3-15, worst to best. The study groups' average subscore changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| Primary | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination | Self-reported survey of quality of life as related to respondents' environment, score range 8-40, worst to best. The study groups' average subscore changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| Primary | Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination | Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| Primary | Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination | Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared. | Analysis excludes 17 Usual Care participants who would later self-select (breaking their randomization) to join "Usual Care then Lifestyle Balance" group to receive the Lifestyle Balance intervention. | Posted | Mean | Standard Error | Scores on a scale per week | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. |
|
|
|
|
| 59 |
| 8 |
| 59 |
| 0 |
| 59 |
| EG001 | Lifestyle Balance | Weight management group education and individual counseling Lifestyle Balance: Patients assigned 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 - Be given a 7% weight loss goal - Be assisted in obtaining a 500 calorie reduction per day -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 | 2 | 79 | 7 | 79 | 0 | 79 |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
| Surgical and medical procedures - Other, specify | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Pacemaker implantation |
|
| Surgical and medical procedures - Other, specify | Reproductive system and breast disorders | CTCAE (4.0) | Non-systematic Assessment | Penile prosthesis implantation |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
| Chest pain - cardiac | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
| Wound dehiscence | Eye disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
| Psychosis | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Non-systematic Assessment | Positive test for small cell neuroendocrine carcinoma |
|
| Agitation | Psychiatric disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Non-systematic Assessment | Broken leg |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment | Hospitalization for recovery |
|
Not provided
Not provided
Not provided
| 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 |