Diabetes, Obesity, Weight Gain
Conditions
Keywords
Antipsychotic, Bipolar, Diabetes, Mental Illness, Nutrition, Obesity, Schizoaffective, Schizophrenia, Weight Gain, Weight Loss
Brief summary
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.
Interventions
BEHAVIORALLifestyle 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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Must be a Veteran * Diagnosis of psychotic disorders, schizophrenia, schizoaffective disorder and bipolar illness * Age 18-70 * Clinically determined to require ongoing treatment with Second Generation Antipsychotics (SGA) such as olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine * Experienced weight gain since treatment with SGA's * Inpatient or outpatient at Long Beach, West Los Angeles, Sepulveda, or Downtown VA * Competent to sign informed consent
Exclusion criteria
* Have recently been diagnosed with schizophrenia (less than 1 year) * Are pregnant or breast feeding a baby * Have a medically unstable condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Waist Circumference Change Per Week From Baseline to Termination | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 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. |
| Mean Weight Change Per Week From Baseline to Termination | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | Participants' weight was measured at each visit by study personnel using hospital scales, and the study groups' average weight changes per week were compared. |
| Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 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. |
| Mean Serum Insulin Level Change Per Week From Baseline to Termination | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | Results obtained through VA facility's Outpatient Lab. The study groups' average serum level changes per week were then compared. |
| Mean Triglycerides Level Change Per Week From Baseline to Termination | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. |
| Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. |
| Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination | Up to 5 observations per person, at baseline, 3 months, 6 months, 9 months, and 12 months. | Results obtained through VA facility's Outpatient Lab. The study groups' average blood level changes per week were then compared. |
| Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination | Up to 4 observations per person,at baseline, 2 months, 6 months, and 12 months. | 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. |
| Change in Mean Total Calories Consumed Per Week From Baseline to Termination | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 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. |
| Change in Mean Empty Calories Consumed Per Week From Baseline to Termination | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 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. |
| Change in Mean Total Exercise Time Per Week From Baseline to Termination | Up to 19 observations per person, weekly for the first 2 months, then monthly for 10 months. | 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. |
| Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 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. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 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. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 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. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 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. |
| WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | 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. |
| Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | Clinician-assessed symptom survey, score range 18 - 126, best to worst. The study groups' average score changes per week were then compared. |
| Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination | Up to 4 observations per person, at baseline, 2 months, 6 months, and 12 months. | Self-reported symptom survey, score range 0 - 63, best to worst. The study groups' average score changes per week were then compared. |
Countries
United States
Participant flow
Recruitment details
Recruitment from outpatient mental health clinics at four southern California VA facilities occurred from September 2010 through March 2014.
Pre-assignment details
Participants were terminated from study prior to randomization to study groups due to screen failure or withdrawal from study during the baseline assessment period.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 59 |
| 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 | 62 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Total | Lifestyle Balance | Usual Care |
|---|---|---|---|
| Age at Onset | 29.58 years STANDARD_DEVIATION 11.6 | 30.11 years STANDARD_DEVIATION 12.8 | 29.07 years STANDARD_DEVIATION 10.4 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 61 Participants | 58 Participants |
| Age, Continuous | 51.22 years STANDARD_DEVIATION 9.6 | 51.87 years STANDARD_DEVIATION 9.3 | 50.54 years STANDARD_DEVIATION 10 |
| Antipsychotic (Weight Gain Risk) Aripiprazole/Ziprasidone (Low) | 46 Participants | 24 Participants | 22 Participants |
| Antipsychotic (Weight Gain Risk) Multiple | 14 Participants | 7 Participants | 7 Participants |
| Antipsychotic (Weight Gain Risk) Olanzapine/Clozapine (High) | 17 Participants | 8 Participants | 9 Participants |
| Antipsychotic (Weight Gain Risk) Other | 12 Participants | 7 Participants | 5 Participants |
| Antipsychotic (Weight Gain Risk) Risperidone/Quetiapine (Med) | 60 Participants | 30 Participants | 30 Participants |
| Diagnosis Bipolar | 17 Participants | 5 Participants | 12 Participants |
| Diagnosis Multiple | 17 Participants | 10 Participants | 7 Participants |
| Diagnosis Other | 12 Participants | 6 Participants | 6 Participants |
| Diagnosis Schizoaffective | 35 Participants | 22 Participants | 13 Participants |
| Diagnosis Schizophrenia | 40 Participants | 19 Participants | 21 Participants |
| Education Bachelor's or Equivalent Degree | 16 Participants | 10 Participants | 6 Participants |
| Education Higher Prof. Degree | 3 Participants | 2 Participants | 1 Participants |
| Education High School Diploma/GED | 96 Participants | 47 Participants | 49 Participants |
| Education No diploma | 5 Participants | 3 Participants | 2 Participants |
| Job Status None | 92 Participants | 44 Participants | 48 Participants |
| Job Status Paid Work | 12 Participants | 9 Participants | 3 Participants |
| Job Status Unpaid Work | 15 Participants | 8 Participants | 7 Participants |
| Length of Illness | 21.43 years STANDARD_DEVIATION 13.5 | 21.46 years STANDARD_DEVIATION 14 | 21.40 years STANDARD_DEVIATION 13.1 |
| Living Situation Board and Care | 33 Participants | 16 Participants | 17 Participants |
| Living Situation Own Home | 13 Participants | 11 Participants | 2 Participants |
| Living Situation Rental Home/Apt | 49 Participants | 23 Participants | 26 Participants |
| Living Situation Transitional | 4 Participants | 1 Participants | 3 Participants |
| Living Situation With Relatives | 21 Participants | 11 Participants | 10 Participants |
| Marital Status Divorced/Widower | 43 Participants | 17 Participants | 26 Participants |
| Marital Status Married | 17 Participants | 12 Participants | 5 Participants |
| Marital Status Single/Cohabiting | 61 Participants | 33 Participants | 28 Participants |
| Race/Ethnicity, Customized African American or Black | 38 Participants | 19 Participants | 19 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized Caucasian, White | 53 Participants | 31 Participants | 22 Participants |
| Race/Ethnicity, Customized Hispanic, Latino, or Spanish Origin | 16 Participants | 8 Participants | 8 Participants |
| Race/Ethnicity, Customized Mixed Heritage or Other | 5 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Native American or Alaska Native | 4 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 121 participants | 62 participants | 59 participants |
| Sex: Female, Male Female | 27 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 94 Participants | 52 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 59 | 2 / 79 |
| other Total, other adverse events | 0 / 59 | 0 / 79 |
| serious Total, serious adverse events | 8 / 59 | 7 / 79 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | Beck Anxiety Inventory (BAI) Mean Total Score Change Per Week From Baseline to Termination | -0.11 Scores on a scale per week | Standard Error 0.03 |
p-value: 0.763Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | Brief Psychiatric Rating Scale (BPRS) Mean Total Score Change Per Week From Baseline to Termination | -0.002 Scores on a scale per week | Standard Error 0.001 |
p-value: <0.001Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Mean Empty Calories Consumed Per Week From Baseline to Termination | -3.02 Calories per week | Standard Error 11.79 |
| Lifestyle Balance | Change in Mean Empty Calories Consumed Per Week From Baseline to Termination | -4.53 Calories per week | Standard Error 2.25 |
p-value: 0.9Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Mean Total Calories Consumed Per Week From Baseline to Termination | -12.3 Calories per week | Standard Error 12.37 |
| Lifestyle Balance | Change in Mean Total Calories Consumed Per Week From Baseline to Termination | -6.8 Calories per week | Standard Error 2.37 |
p-value: 0.663Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Change in Mean Total Exercise Time Per Week From Baseline to Termination | 0.84 Minutes per week | Standard Error 0.65 |
| Lifestyle Balance | Change in Mean Total Exercise Time Per Week From Baseline to Termination | 0.18 Minutes per week | Standard Error 0.47 |
p-value: 0.415Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | Health Knowledge Quiz Mean Total Score Change Per Week From Baseline to Termination | 0.01 Scores on a scale per week | Standard Error 0.01 |
p-value: 0.652Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination | 0.035 Units on a scale per week | Standard Error 0.011 |
| Lifestyle Balance | Mean Body Mass Index (BMI) Change Per Week From Baseline to Termination | -0.009 Units on a scale per week | Standard Error 0.002 |
p-value: <0.001Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination | 0.459 Mg/dL per week | Standard Error 0.204 |
| Lifestyle Balance | Mean High-Density Lipoprotein (HDL) Cholesterol Level Change Per Week From Baseline to Termination | 0.056 Mg/dL per week | Standard Error 0.043 |
p-value: 0.322Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination | -0.031 Mg/dL per week | Standard Error 0.105 |
| Lifestyle Balance | Mean Low-Density Lipoprotein (LDL) Cholesterol Level Change Per Week From Baseline to Termination | 0.218 Mg/dL per week | Standard Error 0.208 |
p-value: 0.92Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Serum Insulin Level Change Per Week From Baseline to Termination | -0.018 Pmol/L per week | Standard Error 1.23 |
| Lifestyle Balance | Mean Serum Insulin Level Change Per Week From Baseline to Termination | -0.44 Pmol/L per week | Standard Error 0.28 |
p-value: 0.676Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Triglycerides Level Change Per Week From Baseline to Termination | 5.13 Mg/dL per week | Standard Error 2.31 |
| Lifestyle Balance | Mean Triglycerides Level Change Per Week From Baseline to Termination | -0.2 Mg/dL per week | Standard Error 0.45 |
p-value: 0.141Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | Mean University Rhode Island Change Assessment Scale (URICA) Total Score Change Per Week From Baseline to Termination | -0.006 Scores on a scale per week | Standard Error 0.004 |
p-value: 0.687Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Waist Circumference Change Per Week From Baseline to Termination | -0.011 Inches per week | Standard Error 0.0136 |
| Lifestyle Balance | Mean Waist Circumference Change Per Week From Baseline to Termination | -0.016 Inches per week | Standard Error 0.003 |
p-value: 0.718Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Mean Weight Change Per Week From Baseline to Termination | 0.133 Pounds per week | Standard Error 0.057 |
| Lifestyle Balance | Mean Weight Change Per Week From Baseline to Termination | -0.0756 Pounds per week | Standard Error 0.0135 |
p-value: <0.001Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 1 Score Change Per Week From Baseline to Termination | 0.013 Scores on a scale per week | Standard Error 0.011 |
p-value: 0.22Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 2 Score Change Per Week From Baseline to Termination | -0.002 Scores on a scale per week | Standard Error 0.009 |
p-value: 0.059Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 3 Score Change Per Week From Baseline to Termination | 0.008 Scores on a scale per week | Standard Error 0.007 |
p-value: 0.79Mixed Models Analysis
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | 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 |
| Lifestyle Balance | WHO Quality of Life-BREF (WHOQOL-BREF) Mean Domain 4 Score Change Per Week From Baseline to Termination | 0 Scores on a scale per week | Standard Error 0.011 |
p-value: 0.146Mixed Models Analysis