Trial Outcomes & Findings for Healthy Lifestyles for Mentally Ill People Who Have Experienced Weight Gain From Their Antipsychotic Medications - 2 (NCT NCT01052714)
NCT ID: NCT01052714
Last Updated: 2018-08-09
Results Overview
Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.
Results posted on
2018-08-09
Participant Flow
Recruitment from outpatient mental health clinics at four southern California VA facilities occurred from September 2010 through March 2014.
Participants were terminated from study prior to randomization to study groups due to screen failure or withdrawal from study during the baseline assessment period.
Participant milestones
| Measure |
Usual Care
Control group with time-matched study visits
|
Lifestyle Balance
Weight management group education and individual counseling
Patients randomized to the 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
|
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:
* 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
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
62
|
17
|
|
Overall Study
COMPLETED
|
17
|
33
|
15
|
|
Overall Study
NOT COMPLETED
|
25
|
29
|
2
|
Reasons for withdrawal
| Measure |
Usual Care
Control group with time-matched study visits
|
Lifestyle Balance
Weight management group education and individual counseling
Patients randomized to the 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
|
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:
* 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
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
3
|
0
|
|
Overall Study
Death
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
0
|
|
Overall Study
Physician Decision
|
9
|
9
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
12
|
1
|
Baseline Characteristics
One Usual Care subject declined to respond.
Baseline characteristics by cohort
| Measure |
Usual Care
n=59 Participants
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.
|
Lifestyle Balance
n=62 Participants
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
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=59 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=121 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=59 Participants
|
61 Participants
n=62 Participants
|
119 Participants
n=121 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=59 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=121 Participants
|
|
Age, Continuous
|
50.54 years
STANDARD_DEVIATION 10.0 • n=59 Participants
|
51.87 years
STANDARD_DEVIATION 9.3 • n=62 Participants
|
51.22 years
STANDARD_DEVIATION 9.6 • n=121 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=59 Participants
|
10 Participants
n=62 Participants
|
27 Participants
n=121 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=59 Participants
|
52 Participants
n=62 Participants
|
94 Participants
n=121 Participants
|
|
Race/Ethnicity, Customized
African American or Black
|
19 Participants
n=59 Participants
|
19 Participants
n=62 Participants
|
38 Participants
n=121 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
3 Participants
n=59 Participants
|
2 Participants
n=62 Participants
|
5 Participants
n=121 Participants
|
|
Race/Ethnicity, Customized
Caucasian, White
|
22 Participants
n=59 Participants
|
31 Participants
n=62 Participants
|
53 Participants
n=121 Participants
|
|
Race/Ethnicity, Customized
Hispanic, Latino, or Spanish Origin
|
8 Participants
n=59 Participants
|
8 Participants
n=62 Participants
|
16 Participants
n=121 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
3 Participants
n=59 Participants
|
1 Participants
n=62 Participants
|
4 Participants
n=121 Participants
|
|
Race/Ethnicity, Customized
Mixed Heritage or Other
|
4 Participants
n=59 Participants
|
1 Participants
n=62 Participants
|
5 Participants
n=121 Participants
|
|
Region of Enrollment
United States
|
59 participants
n=59 Participants
|
62 participants
n=62 Participants
|
121 participants
n=121 Participants
|
|
Living Situation
Own Home
|
2 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
11 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
13 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Living Situation
Rental Home/Apt
|
26 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
23 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
49 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Living Situation
With Relatives
|
10 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
11 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
21 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Living Situation
Board and Care
|
17 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
16 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
33 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Living Situation
Transitional
|
3 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
1 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
4 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Education
No diploma
|
2 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
3 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
5 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Education
High School Diploma/GED
|
49 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
47 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
96 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Education
Bachelor's or Equivalent Degree
|
6 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
10 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
16 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Education
Higher Prof. Degree
|
1 Participants
n=58 Participants • One Usual Care subject declined to respond.
|
2 Participants
n=62 Participants • One Usual Care subject declined to respond.
|
3 Participants
n=120 Participants • One Usual Care subject declined to respond.
|
|
Marital Status
Married
|
5 Participants
n=59 Participants
|
12 Participants
n=62 Participants
|
17 Participants
n=121 Participants
|
|
Marital Status
Single/Cohabiting
|
28 Participants
n=59 Participants
|
33 Participants
n=62 Participants
|
61 Participants
n=121 Participants
|
|
Marital Status
Divorced/Widower
|
26 Participants
n=59 Participants
|
17 Participants
n=62 Participants
|
43 Participants
n=121 Participants
|
|
Job Status
Paid Work
|
3 Participants
n=58 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
9 Participants
n=61 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
12 Participants
n=119 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
|
Job Status
Unpaid Work
|
7 Participants
n=58 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
8 Participants
n=61 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
15 Participants
n=119 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
|
Job Status
None
|
48 Participants
n=58 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
44 Participants
n=61 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
92 Participants
n=119 Participants • One Usual Care and one Lifestyle Balance subject declined to respond.
|
|
Diagnosis
Schizophrenia
|
21 Participants
n=59 Participants
|
19 Participants
n=62 Participants
|
40 Participants
n=121 Participants
|
|
Diagnosis
Schizoaffective
|
13 Participants
n=59 Participants
|
22 Participants
n=62 Participants
|
35 Participants
n=121 Participants
|
|
Diagnosis
Bipolar
|
12 Participants
n=59 Participants
|
5 Participants
n=62 Participants
|
17 Participants
n=121 Participants
|
|
Diagnosis
Multiple
|
7 Participants
n=59 Participants
|
10 Participants
n=62 Participants
|
17 Participants
n=121 Participants
|
|
Diagnosis
Other
|
6 Participants
n=59 Participants
|
6 Participants
n=62 Participants
|
12 Participants
n=121 Participants
|
|
Antipsychotic (Weight Gain Risk)
Olanzapine/Clozapine (High)
|
9 Participants
n=59 Participants
|
8 Participants
n=62 Participants
|
17 Participants
n=121 Participants
|
|
Antipsychotic (Weight Gain Risk)
Risperidone/Quetiapine (Med)
|
30 Participants
n=59 Participants
|
30 Participants
n=62 Participants
|
60 Participants
n=121 Participants
|
|
Antipsychotic (Weight Gain Risk)
Aripiprazole/Ziprasidone (Low)
|
22 Participants
n=59 Participants
|
24 Participants
n=62 Participants
|
46 Participants
n=121 Participants
|
|
Antipsychotic (Weight Gain Risk)
Other
|
5 Participants
n=59 Participants
|
7 Participants
n=62 Participants
|
12 Participants
n=121 Participants
|
|
Antipsychotic (Weight Gain Risk)
Multiple
|
7 Participants
n=59 Participants
|
7 Participants
n=62 Participants
|
14 Participants
n=121 Participants
|
|
Length of Illness
|
21.40 years
STANDARD_DEVIATION 13.1 • n=59 Participants
|
21.46 years
STANDARD_DEVIATION 14.0 • n=62 Participants
|
21.43 years
STANDARD_DEVIATION 13.5 • n=121 Participants
|
|
Age at Onset
|
29.07 years
STANDARD_DEVIATION 10.4 • n=59 Participants
|
30.11 years
STANDARD_DEVIATION 12.8 • n=62 Participants
|
29.58 years
STANDARD_DEVIATION 11.6 • n=121 Participants
|
PRIMARY outcome
Timeframe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.Population: 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.
Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean Weight Change Per Week From Baseline to Termination
|
0.133 Pounds per week
Standard Error 0.057
|
-0.0756 Pounds per week
Standard Error 0.0135
|
PRIMARY outcome
Timeframe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean Waist Circumference Change Per Week From Baseline to Termination
|
-0.011 Inches per week
Standard Error 0.0136
|
-0.016 Inches per week
Standard Error 0.003
|
PRIMARY outcome
Timeframe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination
|
0.035 Units on a scale per week
Standard Error 0.011
|
-0.009 Units on a scale per week
Standard Error 0.002
|
PRIMARY outcome
Timeframe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.Population: 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.
Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean Serum Insulin Level Change Per Week From Baseline to Termination
|
-0.018 Pmol/L per week
Standard Error 1.23
|
-0.44 Pmol/L per week
Standard Error 0.28
|
PRIMARY outcome
Timeframe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.Population: 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.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean Triglycerides Level Change Per Week From Baseline to Termination
|
5.13 Mg/dL per week
Standard Error 2.31
|
-0.2 Mg/dL per week
Standard Error 0.45
|
PRIMARY outcome
Timeframe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.Population: 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.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination
|
-0.031 Mg/dL per week
Standard Error 0.105
|
0.218 Mg/dL per week
Standard Error 0.208
|
PRIMARY outcome
Timeframe: Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months.Population: 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.
Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination
|
0.459 Mg/dL per week
Standard Error 0.204
|
0.056 Mg/dL per week
Standard Error 0.043
|
PRIMARY outcome
Timeframe: Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination
|
0.02 Scores on a scale per week
Standard Error 0.01
|
0.01 Scores on a scale per week
Standard Error 0.01
|
PRIMARY outcome
Timeframe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Change in Mean Total Calories Consumed Per Week From Baseline to Termination
|
-12.3 Calories per week
Standard Error 12.37
|
-6.8 Calories per week
Standard Error 2.37
|
PRIMARY outcome
Timeframe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Change in Mean Empty Calories Consumed Per Week From Baseline to Termination
|
-3.02 Calories per week
Standard Error 11.79
|
-4.53 Calories per week
Standard Error 2.25
|
PRIMARY outcome
Timeframe: Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Change in Mean Total Exercise Time Per Week From Baseline to Termination
|
0.84 Minutes per week
Standard Error 0.65
|
0.18 Minutes per week
Standard Error 0.47
|
PRIMARY outcome
Timeframe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination
|
-0.009 Scores on a scale per week
Standard Error 0.006
|
-0.006 Scores on a scale per week
Standard Error 0.004
|
PRIMARY outcome
Timeframe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination
|
0.037 Scores on a scale per week
Standard Error 0.016
|
0.013 Scores on a scale per week
Standard Error 0.011
|
PRIMARY outcome
Timeframe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination
|
0.027 Scores on a scale per week
Standard Error 0.012
|
-0.002 Scores on a scale per week
Standard Error 0.009
|
PRIMARY outcome
Timeframe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination
|
0.005 Scores on a scale per week
Standard Error 0.011
|
0.008 Scores on a scale per week
Standard Error 0.007
|
PRIMARY outcome
Timeframe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.Population: 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.
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.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination
|
0.03 Scores on a scale per week
Standard Error 0.012
|
0 Scores on a scale per week
Standard Error 0.011
|
PRIMARY outcome
Timeframe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.Population: 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.
Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination
|
-0.005 Scores on a scale per week
Standard Error 0.001
|
-0.002 Scores on a scale per week
Standard Error 0.001
|
PRIMARY outcome
Timeframe: Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months.Population: 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.
Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared.
Outcome measures
| Measure |
Usual Care
n=42 Participants
Control group with time-matched study visits.
|
Lifestyle Balance
n=62 Participants
Weight management group education and individual counseling to review goals and diet and exercise journals.
|
|---|---|---|
|
Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination
|
-0.09 Scores on a scale per week
Standard Error 0.05
|
-0.11 Scores on a scale per week
Standard Error 0.03
|
Adverse Events
Usual Care
Serious events: 8 serious events
Other events: 0 other events
Deaths: 1 deaths
Lifestyle Balance
Serious events: 7 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Usual Care
n=59 participants at risk
Control group with time-matched study visits
|
Lifestyle Balance
n=79 participants at risk
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
|
|---|---|---|
|
General disorders
Death NOS
|
1.7%
1/59 • Number of events 1 • 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.
|
2.5%
2/79 • Number of events 2 • 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.
|
|
Psychiatric disorders
Depression
|
0.00%
0/59 • 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.
|
1.3%
1/79 • Number of events 1 • 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.
|
|
Cardiac disorders
Surgical and medical procedures - Other, specify
|
1.7%
1/59 • Number of events 1 • 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.
|
0.00%
0/79 • 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.
|
|
Reproductive system and breast disorders
Surgical and medical procedures - Other, specify
|
1.7%
1/59 • Number of events 1 • 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.
|
0.00%
0/79 • 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.
|
|
General disorders
Non-cardiac chest pain
|
1.7%
1/59 • Number of events 1 • 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.
|
0.00%
0/79 • 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.
|
|
Cardiac disorders
Chest pain - cardiac
|
0.00%
0/59 • 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.
|
1.3%
1/79 • Number of events 1 • 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.
|
|
Eye disorders
Wound dehiscence
|
0.00%
0/59 • 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.
|
1.3%
1/79 • Number of events 1 • 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.
|
|
Psychiatric disorders
Psychosis
|
0.00%
0/59 • 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.
|
1.3%
1/79 • Number of events 1 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
1.7%
1/59 • Number of events 1 • 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.
|
0.00%
0/79 • 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.
|
|
Psychiatric disorders
Agitation
|
1.7%
1/59 • Number of events 2 • 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.
|
1.3%
1/79 • Number of events 2 • 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.
|
|
Gastrointestinal disorders
Rectal pain
|
1.7%
1/59 • Number of events 3 • 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.
|
0.00%
0/79 • 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.
|
|
Injury, poisoning and procedural complications
Fracture
|
1.7%
1/59 • Number of events 1 • 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.
|
0.00%
0/79 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/59 • 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.
|
1.3%
1/79 • Number of events 1 • 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.
|
Other adverse events
Adverse event data not reported
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