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. The investigators use a program based on the American Diabetes Association's Diabetes Prevention Program, and the investigators have modified it to fit the lifestyles of people with mental illness. All participants are educated about nutrition and cutting down fat intake, how and when to exercise, and the causes of diabetes and how to prevent it. Participants must be Veterans who live within one hour of the West Los Angeles VA hospital.
Detailed description
Rationale: The focus of this project is to develop a strategy to combat medication associated weight gain, the most problematic side effect of the newer antipsychotic medications. Improvements in long-term health outcomes might then be expected to change quality of life, promote treatment adherence, rehabilitative potential, and decrease resource utilization. Procedures: Half of the patients will randomized to the behavioral weight loss program (Lifestyle Balance Program) and do the following: Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient Given a 7% weight loss goal Assisted in obtaining a 500 calorie reduction per day Asked to exercise for at least 30 min/day, at least 5 days a week Maintain weekly food and exercise diaries Be quizzed on their knowledge of healthy eating habits and nutrition The other half of the patients will be randomized to Usual Care and will: Receive pamphlets about Lifestyle Balance, starting exercise, and general nutritional information regarding food pyramids and the amount of calories in fast foods. Be encouraged to exercise and eat a healthy diet Not receive classes on nutrition or exercise Be seen on the same schedule as the experimental group, in order to equalize contact time. After six months, if patients in the usual care group wish to participate in the more rigorous behavioral weight loss program they will be given that opportunity. Visits: Time Line: Each subject will be followed for one year. Healthy Lifestyles courses will take eight weeks to complete. Visits will be monthly for the remaining 12 months Enrollment: 120 patients Course of study: October 2005-October 2008 At Beginning and Termination: Informed Consent (at start of study only) Psychiatric interviews and assessments Physical Examination Framingham risk assessment for cardiovascular disease Electrocardiogram Lipid Profile, fasting glucose, Hemoglobin A1C At Each Visit: Vitals, weight, waist circumference, BMI, and % Fat Food and exercise diaries will be reviewed At Month One and Month Six: Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram Psychiatric assessments At Month Nine: Lipid Profile, fasting glucose, Hemoglobin A1C Electrocardiogram Clinical Care: All patients will continue their clinical care with their current psychiatrist and general physician. Medications will not be manipulated for the purpose of this study. Incentives: The group participating in the behavioral intervention program will receive rewards for achieving weight loss goals and be given incentives such as a pedometer and Slimfast meal replacements.
Interventions
BEHAVIORALBehavioral 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
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
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 the West Los Angeles 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 Weight | Weekly/Monthly, up to 1 year | Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group. |
| Change in Predicted Trajectory of Mean BMI Per GLMM Analysis | 12 months | General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics. |
| Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis | 12 months | Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics. |
Countries
United States
Participant flow
Recruitment details
225 volunteers were screened November 2005 to August 2008 from Veterans Hospital psychiatric clinics in West Los Angeles, USA.
Pre-assignment details
122 volunteers met the inclusion criteria, signed the informed consent document, and completed the baseline screening assessments prior to randomization to study groups.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care control group | 48 |
| Lifestyle Balance Weight management education and counseling | 60 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 2 | 0 |
| Overall Study | Lost to Follow-up | 5 | 13 | 1 |
| Overall Study | Not Noted | 1 | 3 | 0 |
| Overall Study | Protocol Violation | 4 | 7 | 1 |
| Overall Study | Withdrawal by Subject | 7 | 10 | 0 |
Baseline characteristics
| Characteristic | Lifestyle Balance | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 49.67 years STANDARD_DEVIATION 6.9 | 49.63 years STANDARD_DEVIATION 7.9138 | 49.58 years STANDARD_DEVIATION 9.1 |
| Age of Onset of Psychiatric Illness | 30.47 years STANDARD_DEVIATION 11.5 | 29.4656 years STANDARD_DEVIATION 10.917 | 28.21 years STANDARD_DEVIATION 10.12 |
| Antipsychotic (Weight Gain Risk) Aripiprazole/Ziprasidone (Low) | 21 participants | 28 participants | 7 participants |
| Antipsychotic (Weight Gain Risk) Multiple | 8 participants | 15 participants | 7 participants |
| Antipsychotic (Weight Gain Risk) Olanzapine/Clozapine (High) | 5 participants | 16 participants | 11 participants |
| Antipsychotic (Weight Gain Risk) Other | 2 participants | 5 participants | 3 participants |
| Antipsychotic (Weight Gain Risk) Risperidone/Quetiapine (Med) | 24 participants | 44 participants | 20 participants |
| Baseline Psychopathology Ratings Antipsychotics Side-effects Checklist, Total | 25.6 units on a scale STANDARD_DEVIATION 3.7 | 25.8667 units on a scale STANDARD_DEVIATION 3.6948 | 26.2 units on a scale STANDARD_DEVIATION 3.7 |
| Baseline Psychopathology Ratings Brief Psychiatric Rating Scale, Total | 34.9 units on a scale STANDARD_DEVIATION 8.8 | 34.2333 units on a scale STANDARD_DEVIATION 8.4483 | 33.4 units on a scale STANDARD_DEVIATION 8 |
| Baseline Psychopathology Ratings Clinical Global Impression Rating | 3.4 units on a scale STANDARD_DEVIATION 0.8 | 3.4 units on a scale STANDARD_DEVIATION 0.7963 | 3.4 units on a scale STANDARD_DEVIATION 0.8 |
| Baseline Psychopathology Ratings Hamilton Depression Rating Scale, Total | 12.7 units on a scale STANDARD_DEVIATION 7.4 | 11.5 units on a scale STANDARD_DEVIATION 6.8776 | 10.0 units on a scale STANDARD_DEVIATION 5.9 |
| Baseline Psychopathology Ratings Heinrichs Quality of Life Scale, Total | 61.1 units on a scale STANDARD_DEVIATION 22.4 | 58.2556 units on a scale STANDARD_DEVIATION 21.0662 | 54.7 units on a scale STANDARD_DEVIATION 18.9 |
| Baseline Psychopathology Ratings Motivational Interview to Assess Stage of Change | 2.9 units on a scale STANDARD_DEVIATION 0.7 | 2.9 units on a scale STANDARD_DEVIATION 0.6967 | 2.9 units on a scale STANDARD_DEVIATION 0.7 |
| Baseline Psychopathology Ratings Self-Assessment of Illness Questionnaire, Total | 79.1 units on a scale STANDARD_DEVIATION 9.4 | 77.9889 units on a scale STANDARD_DEVIATION 9.3433 | 76.6 units on a scale STANDARD_DEVIATION 9.18 |
| Blood Pressure Diastolic | 83.1 mmHg STANDARD_DEVIATION 10.4 | 82.7889 mmHg STANDARD_DEVIATION 10.4459 | 82.4 mmHg STANDARD_DEVIATION 10.6 |
| Blood Pressure Systolic | 126.7 mmHg STANDARD_DEVIATION 13.3 | 125.2778 mmHg STANDARD_DEVIATION 12.7394 | 123.5 mmHg STANDARD_DEVIATION 11.9 |
| Body Mass Index | 34.1 kg/m^2 STANDARD_DEVIATION 5.3 | 34.1889 kg/m^2 STANDARD_DEVIATION 5.0615 | 34.3 kg/m^2 STANDARD_DEVIATION 4.8 |
| Body Weight | 105.3 kg STANDARD_DEVIATION 21 | 105.9222 kg STANDARD_DEVIATION 18.7231 | 106.7 kg STANDARD_DEVIATION 15.6 |
| Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual Bipolar | 23 participants | 32 participants | 9 participants |
| Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual Other | 4 participants | 7 participants | 3 participants |
| Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual Schizoaffective | 12 participants | 20 participants | 8 participants |
| Diagnosis per the Structured Clinical Interview for the Diagnostic and Statistical Manual Schizophrenia | 21 participants | 49 participants | 28 participants |
| Education Level Bachelor's or Equivalent Degree | 6 participants | 15 participants | 9 participants |
| Education Level Higher Professional Degree | 2 participants | 2 participants | 0 participants |
| Education Level HS Diploma/GED | 47 participants | 83 participants | 36 participants |
| Education Level No diploma | 5 participants | 8 participants | 3 participants |
| Framingham Hard Coronary Heart Disease | 11.2 Percent STANDARD_DEVIATION 5.8 | 11.0222 Percent STANDARD_DEVIATION 6.5301 | 10.8 Percent STANDARD_DEVIATION 7.4 |
| Laboratory Tests Glucose | 103.9 mm/dL STANDARD_DEVIATION 38.6 | 108.6556 mm/dL STANDARD_DEVIATION 49.3093 | 114.6 mm/dL STANDARD_DEVIATION 60 |
| Laboratory Tests HDL Cholesterol | 37.3 mm/dL STANDARD_DEVIATION 8.9 | 37.3889 mm/dL STANDARD_DEVIATION 8.9477 | 37.5 mm/dL STANDARD_DEVIATION 9.1 |
| Laboratory Tests LDL Cholesterol | 111 mm/dL STANDARD_DEVIATION 30.9 | 112.4222 mm/dL STANDARD_DEVIATION 33.1885 | 114.2 mm/dL STANDARD_DEVIATION 36.1 |
| Laboratory Tests Total Cholesterol | 178.9 mm/dL STANDARD_DEVIATION 38.1 | 181.5667 mm/dL STANDARD_DEVIATION 40.6457 | 184.9 mm/dL STANDARD_DEVIATION 43.8 |
| Laboratory Tests Triglycerides | 161.3 mm/dL STANDARD_DEVIATION 117.9 | 161.3889 mm/dL STANDARD_DEVIATION 110.368 | 161.5 mm/dL STANDARD_DEVIATION 101.4 |
| Length of Psychiatric Illness | 18.86 years STANDARD_DEVIATION 11.8 | 19.5889 years STANDARD_DEVIATION 11.7732 | 20.5 years STANDARD_DEVIATION 11.8 |
| Living Situation Board and Care | 42 participants | 82 participants | 40 participants |
| Living Situation Homeless | 0 participants | 0 participants | 0 participants |
| Living Situation Own Home | 1 participants | 1 participants | 0 participants |
| Living Situation Rental Home/Apt | 16 participants | 22 participants | 6 participants |
| Living Situation With Relatives | 1 participants | 3 participants | 2 participants |
| Marital Status Divorced/Widower | 29 participants | 45 participants | 16 participants |
| Marital Status Married | 4 participants | 12 participants | 8 participants |
| Marital Status Single/Cohabiting | 27 participants | 51 participants | 24 participants |
| Medical Comorbidity Diabetes | 15 participants | 26 participants | 11 participants |
| Medical Comorbidity Dyslipidemia | 32 participants | 55 participants | 23 participants |
| Medical Comorbidity Hypertension | 33 participants | 60 participants | 27 participants |
| Medical Comorbidity Metabolic Syndrome | 40 participants | 65 participants | 25 participants |
| Medical Comorbidity Obesity | 40 participants | 72 participants | 32 participants |
| Medical Comorbidity Required Exercise Tolerance Test | 7 participants | 12 participants | 5 participants |
| Microalbumin/Creatinine | 16.12 mgMA/gCrt STANDARD_DEVIATION 39.7 | 15.0889 mgMA/gCrt STANDARD_DEVIATION 34.4026 | 13.8 mgMA/gCrt STANDARD_DEVIATION 26.7 |
| Occupation None | 53 participants | 95 participants | 42 participants |
| Occupation Paid Work | 6 participants | 9 participants | 3 participants |
| Occupation Unpaid Work | 1 participants | 4 participants | 3 participants |
| Percent Body Fat | 30.8 percentage STANDARD_DEVIATION 5.7 | 30.5333 percentage STANDARD_DEVIATION 6.0941 | 30.2 percentage STANDARD_DEVIATION 6.6 |
| Race/Ethnicity, Customized African American or Black | 25 participants | 49 participants | 24 participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 2 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Caucasian, White | 24 participants | 43 participants | 19 participants |
| Race/Ethnicity, Customized Hispanic, Latino, or Spanish Origin | 6 participants | 9 participants | 3 participants |
| Race/Ethnicity, Customized Mixed Heritage or Other | 3 participants | 5 participants | 2 participants |
| Race/Ethnicity, Customized Native American or Alaska Native | 0 participants | 0 participants | 0 participants |
| Region of Enrollment United States | 60 participants | 108 participants | 48 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 54 Participants | 96 Participants | 42 Participants |
| Waist Circumference | 117.1 cm STANDARD_DEVIATION 14.5 | 117.9889 cm STANDARD_DEVIATION 13.19 | 119.1 cm STANDARD_DEVIATION 11.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 48 | 0 / 60 | 1 / 14 |
| serious Total, serious adverse events | 8 / 48 | 9 / 60 | 1 / 14 |
Outcome results
Primary
Change in Predicted Trajectory of Mean BMI Per GLMM Analysis
General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we compared different options to model these trajectories and found a linear model, which assumes that the same rate of change is maintained over the whole study, provided a good fit to the data. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care (UC) | Change in Predicted Trajectory of Mean BMI Per GLMM Analysis | 0.6 kg/m^2 |
| Lifestyle Balance (LB) | Change in Predicted Trajectory of Mean BMI Per GLMM Analysis | -1.7 kg/m^2 |
Primary
Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis
Computed as % body fat at 12 month - % body fat at baseline. General Linear Mixed Model (GLMM) is a full information maximum likelihood approach that permits inclusion of all available data and provides unbiased parameter estimates even if there are missing data under the condition that data are missing at random. The GLMM approach assumes that every patient is on a specific trajectory over time and that both the slope and the shape of this trajectory are a potential function of group membership or other person-level covariates. Using a likelihood ratio test, we found a linear model, assuming the same rate of change throughout the study, provided a good fit to the data compared to other models. We used a linear model of the average rate of change over time (slope) for all comparisons. To illustrate the magnitude of difference between slopes for major outcomes, we report the estimated difference at 12 months between two hypothetical participants with identical baseline characteristics.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care (UC) | Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis | 1.5 Body Fat Percentage Change |
| Lifestyle Balance (LB) | Change in Predicted Trajectory of Mean Body Fat Percentage Per GLMM Analysis | -2 Body Fat Percentage Change |
Primary
Mean Weight
Average weight of subjects attending each of the first 8 weekly visits and the 10 monthly visits which followed, per study group.
Time frame: Weekly/Monthly, up to 1 year
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care (UC) | Mean Weight | Week 38 (n=26, 28) | 233.23 Pounds | Standard Deviation 43.56 |
| Usual Care (UC) | Mean Weight | Week 17 (n=36, 34) | 236.81 Pounds | Standard Deviation 38.09 |
| Usual Care (UC) | Mean Weight | Week 21 (n=36, 36) | 238.56 Pounds | Standard Deviation 39.92 |
| Usual Care (UC) | Mean Weight | Week 26 (n=31, 34) | 236.26 Pounds | Standard Deviation 41.24 |
| Usual Care (UC) | Mean Weight | Week 30 (n=28, 30) | 236.94 Pounds | Standard Deviation 45.59 |
| Usual Care (UC) | Mean Weight | Week 34 (n=26, 28) | 239.3 Pounds | Standard Deviation 48.37 |
| Usual Care (UC) | Mean Weight | Week 43 (n=24, 25) | 238.61 Pounds | Standard Deviation 46.43 |
| Usual Care (UC) | Mean Weight | Week 48 (n=26, 24) | 238.31 Pounds | Standard Deviation 46 |
| Usual Care (UC) | Mean Weight | Week 52 (n=25, 25) | 238.54 Pounds | Standard Deviation 48.09 |
| Usual Care (UC) | Mean Weight | Week 0 (n=47, 60) | 235.22 Pounds | Standard Deviation 34.51 |
| Usual Care (UC) | Mean Weight | Week 1 (n=44, 56) | 235.95 Pounds | Standard Deviation 35.33 |
| Usual Care (UC) | Mean Weight | Week 2 (n=42, 50) | 232.3 Pounds | Standard Deviation 33.56 |
| Usual Care (UC) | Mean Weight | Week 3 (n=38, 45) | 235.98 Pounds | Standard Deviation 35.88 |
| Usual Care (UC) | Mean Weight | Week 4 (n=41, 47) | 236.89 Pounds | Standard Deviation 36.03 |
| Usual Care (UC) | Mean Weight | Week 5 (n=34, 43) | 235.99 Pounds | Standard Deviation 37.94 |
| Usual Care (UC) | Mean Weight | Week 6 (n=38, 41) | 237.88 Pounds | Standard Deviation 37.84 |
| Usual Care (UC) | Mean Weight | Week 7 (n=36, 42) | 235.3 Pounds | Standard Deviation 36.54 |
| Usual Care (UC) | Mean Weight | Week 8 (n=39, 43) | 236.8 Pounds | Standard Deviation 37.11 |
| Usual Care (UC) | Mean Weight | Week 9 (n=0, 1) | NA Pounds | — |
| Usual Care (UC) | Mean Weight | Week 12 (n=39, 36) | 238.2 Pounds | Standard Deviation 36.72 |
| Lifestyle Balance (LB) | Mean Weight | Week 0 (n=47, 60) | 232.1 Pounds | Standard Deviation 46.3 |
| Lifestyle Balance (LB) | Mean Weight | Week 5 (n=34, 43) | 234.79 Pounds | Standard Deviation 45.95 |
| Lifestyle Balance (LB) | Mean Weight | Week 17 (n=36, 34) | 236.9 Pounds | Standard Deviation 52.7 |
| Lifestyle Balance (LB) | Mean Weight | Week 1 (n=44, 56) | 233.41 Pounds | Standard Deviation 46.1 |
| Lifestyle Balance (LB) | Mean Weight | Week 21 (n=36, 36) | 235.97 Pounds | Standard Deviation 52.46 |
| Lifestyle Balance (LB) | Mean Weight | Week 9 (n=0, 1) | 251 Pounds | Standard Deviation 0 |
| Lifestyle Balance (LB) | Mean Weight | Week 26 (n=31, 34) | 234.11 Pounds | Standard Deviation 54.47 |
| Lifestyle Balance (LB) | Mean Weight | Week 2 (n=42, 50) | 233.34 Pounds | Standard Deviation 47.78 |
| Lifestyle Balance (LB) | Mean Weight | Week 30 (n=28, 30) | 236.23 Pounds | Standard Deviation 58.26 |
| Lifestyle Balance (LB) | Mean Weight | Week 6 (n=38, 41) | 237.38 Pounds | Standard Deviation 52.9 |
| Lifestyle Balance (LB) | Mean Weight | Week 34 (n=26, 28) | 236.53 Pounds | Standard Deviation 59.64 |
| Lifestyle Balance (LB) | Mean Weight | Week 38 (n=26, 28) | 230.21 Pounds | Standard Deviation 48.04 |
| Lifestyle Balance (LB) | Mean Weight | Week 3 (n=38, 45) | 233.54 Pounds | Standard Deviation 42.91 |
| Lifestyle Balance (LB) | Mean Weight | Week 43 (n=24, 25) | 228.25 Pounds | Standard Deviation 48.65 |
| Lifestyle Balance (LB) | Mean Weight | Week 8 (n=39, 43) | 237.65 Pounds | Standard Deviation 51.67 |
| Lifestyle Balance (LB) | Mean Weight | Week 48 (n=26, 24) | 229.94 Pounds | Standard Deviation 50.6 |
| Lifestyle Balance (LB) | Mean Weight | Week 4 (n=41, 47) | 237.84 Pounds | Standard Deviation 51.64 |
| Lifestyle Balance (LB) | Mean Weight | Week 52 (n=25, 25) | 228.39 Pounds | Standard Deviation 51.95 |
| Lifestyle Balance (LB) | Mean Weight | Week 12 (n=39, 36) | 237.54 Pounds | Standard Deviation 51.59 |
| Lifestyle Balance (LB) | Mean Weight | Week 7 (n=36, 42) | 235.5 Pounds | Standard Deviation 52.73 |
Comparison: General Linear Mixed Model (GLMM) used to illustrate the magnitude of difference between slopes for major outcomes for two hypothetical participants with identical baseline characteristics over 12 months.p-value: <0.01Mixed Models Analysis