Trial Outcomes & Findings for Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications (NCT NCT00344500)
NCT ID: NCT00344500
Last Updated: 2016-04-06
Results Overview
Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
122 participants
Primary outcome timeframe
Weekly/Monthly, up to 1 year
Results posted on
2016-04-06
Participant Flow
225 volunteers were screened November 2005 to August 2008 from Veterans Hospital psychiatric clinics in West Los Angeles, USA.
122 volunteers met the inclusion criteria, signed the informed consent document, and completed the baseline screening assessments prior to randomization to study groups.
Participant milestones
| Measure |
Usual Care
Usual Care control group
|
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
* 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
|
Changeover
Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
|
|---|---|---|---|
|
Overall Study
STARTED
|
48
|
60
|
14
|
|
Overall Study
COMPLETED
|
25
|
25
|
12
|
|
Overall Study
NOT COMPLETED
|
23
|
35
|
2
|
Reasons for withdrawal
| Measure |
Usual Care
Usual Care control group
|
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
* 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
|
Changeover
Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
13
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
10
|
0
|
|
Overall Study
Protocol Violation
|
4
|
7
|
1
|
|
Overall Study
Not Noted
|
1
|
3
|
0
|
Baseline Characteristics
Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications
Baseline characteristics by cohort
| Measure |
Usual Care
n=48 Participants
Usual Care control group
|
Lifestyle Balance
n=60 Participants
Weight management education and counseling
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.58 years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
49.67 years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
49.63 years
STANDARD_DEVIATION 7.9138 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
24 participants
n=99 Participants
|
25 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian, White
|
19 participants
n=99 Participants
|
24 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latino, or Spanish Origin
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed Heritage or Other
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=99 Participants
|
60 participants
n=107 Participants
|
108 participants
n=206 Participants
|
|
Living Situation
Own Home
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Living Situation
Rental Home/Apt
|
6 participants
n=99 Participants
|
16 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Living Situation
With Relatives
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Living Situation
Board and Care
|
40 participants
n=99 Participants
|
42 participants
n=107 Participants
|
82 participants
n=206 Participants
|
|
Living Situation
Homeless
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Marital Status
Married
|
8 participants
n=99 Participants
|
4 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Marital Status
Single/Cohabiting
|
24 participants
n=99 Participants
|
27 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
Marital Status
Divorced/Widower
|
16 participants
n=99 Participants
|
29 participants
n=107 Participants
|
45 participants
n=206 Participants
|
|
Education Level
No diploma
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Education Level
HS Diploma/GED
|
36 participants
n=99 Participants
|
47 participants
n=107 Participants
|
83 participants
n=206 Participants
|
|
Education Level
Bachelor's or Equivalent Degree
|
9 participants
n=99 Participants
|
6 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Education Level
Higher Professional Degree
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Occupation
Paid Work
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Occupation
Unpaid Work
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Occupation
None
|
42 participants
n=99 Participants
|
53 participants
n=107 Participants
|
95 participants
n=206 Participants
|
|
Medical Comorbidity
Hypertension
|
27 participants
n=99 Participants
|
33 participants
n=107 Participants
|
60 participants
n=206 Participants
|
|
Medical Comorbidity
Dyslipidemia
|
23 participants
n=99 Participants
|
32 participants
n=107 Participants
|
55 participants
n=206 Participants
|
|
Medical Comorbidity
Diabetes
|
11 participants
n=99 Participants
|
15 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Medical Comorbidity
Metabolic Syndrome
|
25 participants
n=99 Participants
|
40 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Medical Comorbidity
Obesity
|
32 participants
n=99 Participants
|
40 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Medical Comorbidity
Required Exercise Tolerance Test
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual
Schizophrenia
|
28 participants
n=99 Participants
|
21 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual
Schizoaffective
|
8 participants
n=99 Participants
|
12 participants
n=107 Participants
|
20 participants
n=206 Participants
|
|
Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual
Bipolar
|
9 participants
n=99 Participants
|
23 participants
n=107 Participants
|
32 participants
n=206 Participants
|
|
Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual
Other
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Antipsychotic (Weight Gain Risk)
Olanzapine/Clozapine (High)
|
11 participants
n=99 Participants
|
5 participants
n=107 Participants
|
16 participants
n=206 Participants
|
|
Antipsychotic (Weight Gain Risk)
Risperidone/Quetiapine (Med)
|
20 participants
n=99 Participants
|
24 participants
n=107 Participants
|
44 participants
n=206 Participants
|
|
Antipsychotic (Weight Gain Risk)
Aripiprazole/Ziprasidone (Low)
|
7 participants
n=99 Participants
|
21 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Antipsychotic (Weight Gain Risk)
Other
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Antipsychotic (Weight Gain Risk)
Multiple
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
15 participants
n=206 Participants
|
|
Length of Psychiatric Illness
|
20.5 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
18.86 years
STANDARD_DEVIATION 11.8 • n=107 Participants
|
19.5889 years
STANDARD_DEVIATION 11.7732 • n=206 Participants
|
|
Age of Onset of Psychiatric Illness
|
28.21 years
STANDARD_DEVIATION 10.12 • n=99 Participants
|
30.47 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
29.4656 years
STANDARD_DEVIATION 10.917 • n=206 Participants
|
|
Baseline Psychopathology Ratings
Brief Psychiatric Rating Scale, Total
|
33.4 units on a scale
STANDARD_DEVIATION 8.0 • n=99 Participants
|
34.9 units on a scale
STANDARD_DEVIATION 8.8 • n=107 Participants
|
34.2333 units on a scale
STANDARD_DEVIATION 8.4483 • n=206 Participants
|
|
Baseline Psychopathology Ratings
Clinical Global Impression Rating
|
3.4 units on a scale
STANDARD_DEVIATION 0.8 • n=99 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 0.8 • n=107 Participants
|
3.4 units on a scale
STANDARD_DEVIATION 0.7963 • n=206 Participants
|
|
Baseline Psychopathology Ratings
Hamilton Depression Rating Scale, Total
|
10.0 units on a scale
STANDARD_DEVIATION 5.9 • n=99 Participants
|
12.7 units on a scale
STANDARD_DEVIATION 7.4 • n=107 Participants
|
11.5 units on a scale
STANDARD_DEVIATION 6.8776 • n=206 Participants
|
|
Baseline Psychopathology Ratings
Heinrichs Quality of Life Scale, Total
|
54.7 units on a scale
STANDARD_DEVIATION 18.9 • n=99 Participants
|
61.1 units on a scale
STANDARD_DEVIATION 22.4 • n=107 Participants
|
58.2556 units on a scale
STANDARD_DEVIATION 21.0662 • n=206 Participants
|
|
Baseline Psychopathology Ratings
Self-Assessment of Illness Questionnaire, Total
|
76.6 units on a scale
STANDARD_DEVIATION 9.18 • n=99 Participants
|
79.1 units on a scale
STANDARD_DEVIATION 9.4 • n=107 Participants
|
77.9889 units on a scale
STANDARD_DEVIATION 9.3433 • n=206 Participants
|
|
Baseline Psychopathology Ratings
Antipsychotics Side-effects Checklist, Total
|
26.2 units on a scale
STANDARD_DEVIATION 3.7 • n=99 Participants
|
25.6 units on a scale
STANDARD_DEVIATION 3.7 • n=107 Participants
|
25.8667 units on a scale
STANDARD_DEVIATION 3.6948 • n=206 Participants
|
|
Baseline Psychopathology Ratings
Motivational Interview to Assess Stage of Change
|
2.9 units on a scale
STANDARD_DEVIATION 0.7 • n=99 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 0.7 • n=107 Participants
|
2.9 units on a scale
STANDARD_DEVIATION 0.6967 • n=206 Participants
|
|
Body Weight
|
106.7 kg
STANDARD_DEVIATION 15.6 • n=99 Participants
|
105.3 kg
STANDARD_DEVIATION 21.0 • n=107 Participants
|
105.9222 kg
STANDARD_DEVIATION 18.7231 • n=206 Participants
|
|
Body Mass Index
|
34.3 kg/m^2
STANDARD_DEVIATION 4.8 • n=99 Participants
|
34.1 kg/m^2
STANDARD_DEVIATION 5.3 • n=107 Participants
|
34.1889 kg/m^2
STANDARD_DEVIATION 5.0615 • n=206 Participants
|
|
Waist Circumference
|
119.1 cm
STANDARD_DEVIATION 11.4 • n=99 Participants
|
117.1 cm
STANDARD_DEVIATION 14.5 • n=107 Participants
|
117.9889 cm
STANDARD_DEVIATION 13.19 • n=206 Participants
|
|
Percent Body Fat
|
30.2 percentage
STANDARD_DEVIATION 6.6 • n=99 Participants
|
30.8 percentage
STANDARD_DEVIATION 5.7 • n=107 Participants
|
30.5333 percentage
STANDARD_DEVIATION 6.0941 • n=206 Participants
|
|
Framingham Hard Coronary Heart Disease
|
10.8 Percent
STANDARD_DEVIATION 7.4 • n=99 Participants
|
11.2 Percent
STANDARD_DEVIATION 5.8 • n=107 Participants
|
11.0222 Percent
STANDARD_DEVIATION 6.5301 • n=206 Participants
|
|
Blood Pressure
Systolic
|
123.5 mmHg
STANDARD_DEVIATION 11.9 • n=99 Participants
|
126.7 mmHg
STANDARD_DEVIATION 13.3 • n=107 Participants
|
125.2778 mmHg
STANDARD_DEVIATION 12.7394 • n=206 Participants
|
|
Blood Pressure
Diastolic
|
82.4 mmHg
STANDARD_DEVIATION 10.6 • n=99 Participants
|
83.1 mmHg
STANDARD_DEVIATION 10.4 • n=107 Participants
|
82.7889 mmHg
STANDARD_DEVIATION 10.4459 • n=206 Participants
|
|
Laboratory Tests
Glucose
|
114.6 mm/dL
STANDARD_DEVIATION 60 • n=99 Participants
|
103.9 mm/dL
STANDARD_DEVIATION 38.6 • n=107 Participants
|
108.6556 mm/dL
STANDARD_DEVIATION 49.3093 • n=206 Participants
|
|
Laboratory Tests
HDL Cholesterol
|
37.5 mm/dL
STANDARD_DEVIATION 9.1 • n=99 Participants
|
37.3 mm/dL
STANDARD_DEVIATION 8.9 • n=107 Participants
|
37.3889 mm/dL
STANDARD_DEVIATION 8.9477 • n=206 Participants
|
|
Laboratory Tests
Triglycerides
|
161.5 mm/dL
STANDARD_DEVIATION 101.4 • n=99 Participants
|
161.3 mm/dL
STANDARD_DEVIATION 117.9 • n=107 Participants
|
161.3889 mm/dL
STANDARD_DEVIATION 110.368 • n=206 Participants
|
|
Laboratory Tests
LDL Cholesterol
|
114.2 mm/dL
STANDARD_DEVIATION 36.1 • n=99 Participants
|
111 mm/dL
STANDARD_DEVIATION 30.9 • n=107 Participants
|
112.4222 mm/dL
STANDARD_DEVIATION 33.1885 • n=206 Participants
|
|
Laboratory Tests
Total Cholesterol
|
184.9 mm/dL
STANDARD_DEVIATION 43.8 • n=99 Participants
|
178.9 mm/dL
STANDARD_DEVIATION 38.1 • n=107 Participants
|
181.5667 mm/dL
STANDARD_DEVIATION 40.6457 • n=206 Participants
|
|
Microalbumin/Creatinine
|
13.8 mgMA/gCrt
STANDARD_DEVIATION 26.7 • n=99 Participants
|
16.12 mgMA/gCrt
STANDARD_DEVIATION 39.7 • n=107 Participants
|
15.0889 mgMA/gCrt
STANDARD_DEVIATION 34.4026 • n=206 Participants
|
PRIMARY outcome
Timeframe: Weekly/Monthly, up to 1 yearPopulation: 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.
Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.
Outcome measures
| Measure |
Usual Care (UC)
n=48 Participants
Usual Care control group
|
Lifestyle Balance (LB)
n=60 Participants
Behavioral Weight Loss Program
|
|---|---|---|
|
Mean Weight
Week 0 (n=47, 60)
|
235.22 Pounds
Standard Deviation 34.51
|
232.1 Pounds
Standard Deviation 46.3
|
|
Mean Weight
Week 1 (n=44, 56)
|
235.95 Pounds
Standard Deviation 35.33
|
233.41 Pounds
Standard Deviation 46.1
|
|
Mean Weight
Week 2 (n=42, 50)
|
232.3 Pounds
Standard Deviation 33.56
|
233.34 Pounds
Standard Deviation 47.78
|
|
Mean Weight
Week 3 (n=38, 45)
|
235.98 Pounds
Standard Deviation 35.88
|
233.54 Pounds
Standard Deviation 42.91
|
|
Mean Weight
Week 4 (n=41, 47)
|
236.89 Pounds
Standard Deviation 36.03
|
237.84 Pounds
Standard Deviation 51.64
|
|
Mean Weight
Week 5 (n=34, 43)
|
235.99 Pounds
Standard Deviation 37.94
|
234.79 Pounds
Standard Deviation 45.95
|
|
Mean Weight
Week 6 (n=38, 41)
|
237.88 Pounds
Standard Deviation 37.84
|
237.38 Pounds
Standard Deviation 52.9
|
|
Mean Weight
Week 7 (n=36, 42)
|
235.3 Pounds
Standard Deviation 36.54
|
235.5 Pounds
Standard Deviation 52.73
|
|
Mean Weight
Week 8 (n=39, 43)
|
236.8 Pounds
Standard Deviation 37.11
|
237.65 Pounds
Standard Deviation 51.67
|
|
Mean Weight
Week 9 (n=0, 1)
|
NA Pounds
Standard Deviation NA
Data collection at this point only occured in one exceptional case.
|
251 Pounds
Standard Deviation 0
|
|
Mean Weight
Week 17 (n=36, 34)
|
236.81 Pounds
Standard Deviation 38.09
|
236.9 Pounds
Standard Deviation 52.7
|
|
Mean Weight
Week 21 (n=36, 36)
|
238.56 Pounds
Standard Deviation 39.92
|
235.97 Pounds
Standard Deviation 52.46
|
|
Mean Weight
Week 26 (n=31, 34)
|
236.26 Pounds
Standard Deviation 41.24
|
234.11 Pounds
Standard Deviation 54.47
|
|
Mean Weight
Week 30 (n=28, 30)
|
236.94 Pounds
Standard Deviation 45.59
|
236.23 Pounds
Standard Deviation 58.26
|
|
Mean Weight
Week 34 (n=26, 28)
|
239.3 Pounds
Standard Deviation 48.37
|
236.53 Pounds
Standard Deviation 59.64
|
|
Mean Weight
Week 38 (n=26, 28)
|
233.23 Pounds
Standard Deviation 43.56
|
230.21 Pounds
Standard Deviation 48.04
|
|
Mean Weight
Week 43 (n=24, 25)
|
238.61 Pounds
Standard Deviation 46.43
|
228.25 Pounds
Standard Deviation 48.65
|
|
Mean Weight
Week 48 (n=26, 24)
|
238.31 Pounds
Standard Deviation 46
|
229.94 Pounds
Standard Deviation 50.6
|
|
Mean Weight
Week 52 (n=25, 25)
|
238.54 Pounds
Standard Deviation 48.09
|
228.39 Pounds
Standard Deviation 51.95
|
|
Mean Weight
Week 12 (n=39, 36)
|
238.2 Pounds
Standard Deviation 36.72
|
237.54 Pounds
Standard Deviation 51.59
|
PRIMARY outcome
Timeframe: 12 monthsGeneral 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.
Outcome measures
| Measure |
Usual Care (UC)
n=48 Participants
Usual Care control group
|
Lifestyle Balance (LB)
n=60 Participants
Behavioral Weight Loss Program
|
|---|---|---|
|
Change in Predicted Trajectory of Mean BMI Per GLMM Analysis
|
0.6 kg/m^2
|
-1.7 kg/m^2
|
PRIMARY outcome
Timeframe: 12 monthsComputed 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.
Outcome measures
| Measure |
Usual Care (UC)
n=48 Participants
Usual Care control group
|
Lifestyle Balance (LB)
n=60 Participants
Behavioral Weight Loss Program
|
|---|---|---|
|
Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis
|
1.5 Body Fat Percentage Change
|
-2 Body Fat Percentage Change
|
Adverse Events
Usual Care
Serious events: 8 serious events
Other events: 1 other events
Deaths: 0 deaths
Lifestyle Balance
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Changeover
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Usual Care
n=48 participants at risk
Usual Care control group
|
Lifestyle Balance
n=60 participants at risk
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
* 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
|
Changeover
n=14 participants at risk
Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
|
|---|---|---|---|
|
Endocrine disorders
Hyperglycemia
|
2.1%
1/48 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
1.7%
1/60 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Nervous system disorders
Bell's Palsy
|
2.1%
1/48 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/60 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/48 • Four (4) years, between November 2005 and October 2009.
|
3.3%
2/60 • Number of events 2 • Four (4) years, between November 2005 and October 2009.
|
7.1%
1/14 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
|
Infections and infestations
Staph Aureus Infection
|
2.1%
1/48 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/60 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Injury, poisoning and procedural complications
Prescription Medication Overdose
|
0.00%
0/48 • Four (4) years, between November 2005 and October 2009.
|
1.7%
1/60 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/48 • Four (4) years, between November 2005 and October 2009.
|
1.7%
1/60 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pancreatic Mass
|
2.1%
1/48 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/60 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Psychiatric disorders
Exacerbated Psychosis
|
4.2%
2/48 • Number of events 2 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/60 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Vascular disorders
Hypotension
|
2.1%
1/48 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/60 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Endocrine disorders
Acute Pancreatitis
|
0.00%
0/48 • Four (4) years, between November 2005 and October 2009.
|
1.7%
1/60 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Infections and infestations
Syphilis Infection
|
0.00%
0/48 • Four (4) years, between November 2005 and October 2009.
|
1.7%
1/60 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Nervous system disorders
Neurotoxic Chemical Exposure
|
2.1%
1/48 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/60 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Psychiatric disorders
Exacerbated Mania
|
0.00%
0/48 • Four (4) years, between November 2005 and October 2009.
|
1.7%
1/60 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
|
Psychiatric disorders
Exacerbated Depresssion
|
0.00%
0/48 • Four (4) years, between November 2005 and October 2009.
|
1.7%
1/60 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/14 • Four (4) years, between November 2005 and October 2009.
|
Other adverse events
| Measure |
Usual Care
n=48 participants at risk
Usual Care control group
|
Lifestyle Balance
n=60 participants at risk
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
* 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
|
Changeover
n=14 participants at risk
Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chest/rib pain
|
2.1%
1/48 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
0.00%
0/60 • Four (4) years, between November 2005 and October 2009.
|
7.1%
1/14 • Number of events 1 • Four (4) years, between November 2005 and October 2009.
|
Additional Information
Dr. Donna Ames, Principal Investigator
Psychiatry Department at VA Greater Los Angeles Healthcare System
Phone: 310-478-3037
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place