Obesity
Conditions
Keywords
Weight loss, Weight management, Diabetes, Heart disease
Brief summary
The purpose of this study is to compare three methods for managing obesity in rural patients, to see which method will result in patients being able to attain their weight loss goal and maintain that weight loss.
Detailed description
Nearly 20% of the U.S. population lives in rural communities. Rural residents suffer at a higher rate from obesity and obesity-related illnesses, including diabetes, heart disease, and arthritis. Local primary care physicians are an important resource for treating obesity in rural areas because of a lack of other community resources. This study is looking at how effective current, real-world primary care treatment models are in helping rural residents lose weight and maintain that weight loss. Physician clinics will be randomized (like picking numbers from a hat) to conduct one of the three methods. The method a participant is part of will depend on the method their physician's clinic is randomized to. The three methods involved in this study are: 1. Individual weight-management counseling in person (in clinic individual visits) 2. Group weight-management counseling, both in person and by telephone; the latter if preferred by the group (in clinic group visits) 3. Group weight-management counseling by telephone (phone group visits) Participants will be in the study about 24 months. The number of in-person clinic visits and phone calls each participant will be asked to complete depends on the method.
Interventions
BEHAVIORALFee-for-Service Model (FFS, In clinic individual visits)
To be performed by participant's doctor or other healthcare professional in their doctor's office.
BEHAVIORALPatient Centered Medical Home (PCMH, In clinic group visits)
To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
BEHAVIORALDisease Management (DM, Phone group visits)
To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.
Sponsors
Patient-Centered Outcomes Research Institute
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* BMI between 30 kg/m2 and 45 kg/m2. * Live in a rural location. * Have clearance from their primary care provider to participate in a diet and exercise weight control intervention. * Have access to a telephone. * One individual per household will be permitted to enroll in the study.
Exclusion criteria
* History of heart attack in the last six months, stroke in the last six months, or new cancer diagnosis in the last six months. * History of bariatric surgery or planning bariatric surgery in the next two years. * Pregnancy within the last six months or planned within the next two years or currently pregnant or lactating. * Serious medical conditions where weight loss is contraindicated. * End stage renal disease or end stage liver disease. * Other medical contraindications as determined by the patient's primary care physician (PCP); documented PCP clearance will be obtained. * Participants who are already enrolled in, or planning to enroll in another research study where weight loss is targeted. * Participants who plan to relocate outside of their provider's service area or who plan to leave their primary care clinic in the next 2 years. * Unable to read and understand English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Baseline and 6, 18 and 24 months | Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation. |
| Mean Weight Change Over 24 Months; Adjusted | Baseline and 6, 18 and 24 months | Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Baseline and 6, 18 and 24 months | Mean change in diastolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation. |
| Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Mean change in fasting glucose will be compared across all treatment arms; unadjusted except for affiliation. |
| Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Mean change in fasting cholesterol will be compared across all treatment arms; unadjusted except for affiliation. |
| Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Mean change in fasting triglycerides will be compared across all treatment arms; unadjusted except for affiliation. |
| Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Mean change in fasting low density lipoprotein (LDL) will be compared across all treatment arms; unadjusted except for affiliation. |
| Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Baseline and 6, 18 and 24 months | Comparison in percent weight loss from baseline of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation. |
| Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Change in physical quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. |
| Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Mean change in mental quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. |
| Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | Baseline and 6 and 24 months | The Impact of Weight on Quality of Life-Lite (IWQOL-L) measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. The total score ranges from 0 to 100 with higher scores indicating better quality of life. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. |
| Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 (better) to 21 (worse). Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. |
| Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Baseline and 6, 18 and 24 months | Mean change in stress measured using the Perceived Stress Scale (PSS). Scores range from 0 to 40. Higher numbers represent greater levels of stress. Measures will be collected at baseline, 6 months, 18 months and 24 months. Unadjusted except for affiliation. |
| Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Baseline and 6 and 24 months | Mean change in fasting high density lipoprotein (HDL) will be compared across all treatment arms; unadjusted except for affiliation. |
| Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Baseline and 6, 18 and 24 months | Mean change in systolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation. |
Countries
United States
Participant flow
Recruitment details
Patients from 36 medical practices were recruited via mailings and in-clinic referrals. Initial eligibility was assessed via telephone screen. Patients then completed a baseline survey, physician clearance was documented, and finally BMI was verified at the initial study visit. The recruitment period was from 2/15/2016 through 10/2/2017.
Participants by arm
| Arm | Count |
|---|---|
| Fee-for-Service (In Clinic Individual Counseling) Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.
Fee-for-Service Model (FFS): To be performed by participant's doctor or other healthcare professional in their doctor's office. | 473 |
| Patient Centered Medical Home (In Clinic Group Counseling) Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers.
Patient Centered Medical Home (PCMH): To be performed by a registered dietitian, a nurse or other healthcare professional. | 468 |
| Disease Management (Phone Group Counseling) Participants will take part in group weight-management counseling by telephone.
Disease Management (DM): To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling | 466 |
| Total | 1,407 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 3 | 0 |
| Overall Study | Lost to Follow-up | 50 | 44 | 50 |
| Overall Study | Physician Decision | 4 | 5 | 4 |
| Overall Study | Pregnancy | 1 | 3 | 5 |
| Overall Study | Withdrawal by Subject | 13 | 14 | 16 |
Baseline characteristics
| Characteristic | Fee-for-Service (In Clinic Individual Counseling) | Patient Centered Medical Home (In Clinic Group Counseling) | Disease Management (Phone Group Counseling) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 88 Participants | 125 Participants | 94 Participants | 307 Participants |
| Age, Categorical Between 18 and 65 years | 385 Participants | 343 Participants | 372 Participants | 1100 Participants |
| Age, Continuous | 54.1 years STANDARD_DEVIATION 11.5 | 55.7 years STANDARD_DEVIATION 12 | 54.1 years STANDARD_DEVIATION 11.9 | 54.7 years STANDARD_DEVIATION 11.8 |
| Body Mass Index (BMI) | 36.9 kg/m^2 STANDARD_DEVIATION 4 | 36.7 kg/m^2 STANDARD_DEVIATION 3.9 | 36.6 kg/m^2 STANDARD_DEVIATION 3.9 | 36.7 kg/m^2 STANDARD_DEVIATION 4 |
| Race/Ethnicity, Customized Other | 10 Participants | 26 Participants | 18 Participants | 54 Participants |
| Race/Ethnicity, Customized White, Non-Hispanic | 463 Participants | 442 Participants | 448 Participants | 1353 Participants |
| Region of Enrollment United States Isolated rural | 244 Participants | 203 Participants | 212 Participants | 659 Participants |
| Region of Enrollment United States Large rural | 151 Participants | 182 Participants | 165 Participants | 498 Participants |
| Region of Enrollment United States Small rural | 78 Participants | 83 Participants | 89 Participants | 250 Participants |
| Sex: Female, Male Female | 377 Participants | 343 Participants | 361 Participants | 1081 Participants |
| Sex: Female, Male Male | 96 Participants | 125 Participants | 105 Participants | 326 Participants |
| Weight, kg | 103.1 kg STANDARD_DEVIATION 15.4 | 102.9 kg STANDARD_DEVIATION 15.5 | 102.7 kg STANDARD_DEVIATION 15.6 | 102.9 kg STANDARD_DEVIATION 15.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 478 | 3 / 479 | 0 / 475 |
| other Total, other adverse events | 0 / 478 | 0 / 479 | 0 / 475 |
| serious Total, serious adverse events | 94 / 478 | 88 / 479 | 82 / 475 |
Outcome results
Primary
Mean Weight Change Over 24 Months; Adjusted
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic.
Time frame: Baseline and 6, 18 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 24 months | -2.85 kg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 18 months | -3.65 kg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 6 months | -6.01 kg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 18 months | -5.84 kg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 6 months | -8.62 kg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 24 months | -4.69 kg |
| Disease Management (Phone Group Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 6 months | -7.97 kg |
| Disease Management (Phone Group Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 24 months | -4.19 kg |
| Disease Management (Phone Group Counseling) | Mean Weight Change Over 24 Months; Adjusted | Mean weight change at 18 months | -5.44 kg |
Comparison: PCMH (in clinic group counseling) versus FFS (in clinic individual counseling).p-value: 0.02597.5% CI: [-3.5, -0.18]Mixed Models Analysis
Comparison: DM (phone group counseling) versus FFS (in clinic individual counseling)p-value: 0.02597.5% CI: [-2.99, 0.32]Mixed Models Analysis
Comparison: PCMH (in clinic group counseling) versus DM (phone group counseling)p-value: 0.02597.5% CI: [-2.15, 1.15]Mixed Models Analysis
Primary
Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation
Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.
Time frame: Baseline and 6, 18 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 18 months | -3.35 kg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 6 months | -5.73 kg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 24 months | -2.56 kg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 18 months | -5.58 kg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 6 months | -8.34 kg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 24 months | -4.43 kg |
| Disease Management (Phone Group Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 6 months | -7.72 kg |
| Disease Management (Phone Group Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 24 months | -3.92 kg |
| Disease Management (Phone Group Counseling) | Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation | Mean Weight change at 18 months | -5.17 kg |
Comparison: PCMH (in clinic group counseling) versus FFS (in clinic individual counseling)p-value: 0.02597.5% CI: [-3.51, -0.23]Mixed Models Analysis
Comparison: DM (phone group counseling) versus FFS (in clinic individual counseling)p-value: 0.2597.5% CI: [-3, 0.29]Mixed Models Analysis
Comparison: PCMH (in clinic group visits) versus DM (phone group visits)p-value: 0.02597.5% CI: [-2.15, 1.13]Mixed Models Analysis
Secondary
Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation
Mean change in diastolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.
Time frame: Baseline and 6, 18 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 18 months | -1.03 mmHg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 6 months | -2.23 mmHg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 24 months | -0.88 mmHg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 18 months | -1.97 mmHg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 6 months | -2.42 mmHg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 24 months | -0.95 mmHg |
| Disease Management (Phone Group Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 6 months | -2.02 mmHg |
| Disease Management (Phone Group Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 24 months | -0.60 mmHg |
| Disease Management (Phone Group Counseling) | Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Diastolic BP at 18 months | -0.49 mmHg |
Secondary
Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation
Mean change in fasting cholesterol will be compared across all treatment arms; unadjusted except for affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Mean change fasting cholesterol at 6 months | -6.20 mg/dl |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Mean change fasting cholesterol at 24 months | -3.85 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Mean change fasting cholesterol at 6 months | -8.22 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Mean change fasting cholesterol at 24 months | -1.69 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Mean change fasting cholesterol at 6 months | -5.89 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Mean change fasting cholesterol at 24 months | -0.74 mg/dl |
Secondary
Mean Change in Fasting Glucose; Unadjusted Except for Affiliation
Mean change in fasting glucose will be compared across all treatment arms; unadjusted except for affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Mean change fasting glucose at 24 months | 3.07 mg/dl |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Mean change fasting glucose at 6 months | -1.69 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Mean change fasting glucose at 24 months | 0.94 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Mean change fasting glucose at 6 months | -3.71 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Mean change fasting glucose at 24 months | 0.29 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Mean change fasting glucose at 6 months | -4.48 mg/dl |
Secondary
Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation
Mean change in fasting high density lipoprotein (HDL) will be compared across all treatment arms; unadjusted except for affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Mean change fasting HDL at 6 months | 0.25 mg/dl |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Mean change fasting HDL at 24 months | 1.32 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Mean change fasting HDL at 6 months | 0.76 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Mean change fasting HDL at 24 months | 1.88 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Mean change fasting HDL at 6 months | -0.05 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Mean change fasting HDL at 24 months | 2.12 mg/dl |
Secondary
Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation
Mean change in fasting low density lipoprotein (LDL) will be compared across all treatment arms; unadjusted except for affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Mean change fasting LDL at 6 months | -3.38 mg/dl |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Mean change fasting LDL at 24 months | -5.26 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Mean change fasting LDL at 6 months | -4.05 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Mean change fasting LDL at 24 months | -1.38 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Mean change fasting LDL at 6 months | -2.94 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Mean change fasting LDL at 24 months | -0.83 mg/dl |
Secondary
Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation
Mean change in fasting triglycerides will be compared across all treatment arms; unadjusted except for affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Mean change fasting triglycerides at 24 months | -0.46 mg/dl |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Mean change fasting triglycerides at 6 months | -12.61 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Mean change fasting triglycerides at 24 months | -19.17 mg/dl |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Mean change fasting triglycerides at 6 months | -25.39 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Mean change fasting triglycerides at 6 months | -18.61 mg/dl |
| Disease Management (Phone Group Counseling) | Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Mean change fasting triglycerides at 24 months | -10.40 mg/dl |
Secondary
Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Mean change in mental quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Mental Score at 6 months | 1.49 units on a scale |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Mental Score at 24 months | 0.89 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Mental Score at 6 months | 1.92 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Mental Score at 24 months | 0.93 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Mental Score at 6 months | -0.09 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Mental Score at 24 months | -0.07 units on a scale |
Secondary
Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Change in physical quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Physical Score at 6 months | 1.71 units on a scale |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Physical Score at 24 months | 1.39 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Physical Score at 6 months | 2.69 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Physical Score at 24 months | 1.50 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Physical Score at 6 months | 2.61 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change SF-12 Physical Score at 24 months | 0.89 units on a scale |
Secondary
Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation
Measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 (better) to 21 (worse). Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Mean Change PSQI Score at 6 months | -0.70 units on a scale |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Mean Change PSQI Score at 24 months | -0.62 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Mean Change PSQI Score at 6 months | -0.90 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Mean Change PSQI Score at 24 months | -0.75 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Mean Change PSQI Score at 6 months | -0.97 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Mean Change PSQI Score at 24 months | -0.56 units on a scale |
Secondary
Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation
Mean change in stress measured using the Perceived Stress Scale (PSS). Scores range from 0 to 40. Higher numbers represent greater levels of stress. Measures will be collected at baseline, 6 months, 18 months and 24 months. Unadjusted except for affiliation.
Time frame: Baseline and 6, 18 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 24 months | -0.56 units on a scale |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 18 months | 0.53 units on a scale |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 6 months | 0.03 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 24 months | -0.31 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 6 months | -0.33 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 18 months | 0.46 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 24 months | -0.58 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 18 months | 0.69 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in PSS Score at 6 months | -0.26 units on a scale |
Secondary
Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation
Mean change in systolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.
Time frame: Baseline and 6, 18 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 24 months | -0.58 mmHg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 18 months | -0.27 mmHg |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 6 months | -2.41 mmHg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 24 months | 0.12 mmHg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 6 months | -2.08 mmHg |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 18 months | -0.10 mmHg |
| Disease Management (Phone Group Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 24 months | -1.60 mmHg |
| Disease Management (Phone Group Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 18 months | -1.28 mmHg |
| Disease Management (Phone Group Counseling) | Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation | Mean change Systolic BP at 6 months | -2.27 mmHg |
Secondary
Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation
The Impact of Weight on Quality of Life-Lite (IWQOL-L) measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. The total score ranges from 0 to 100 with higher scores indicating better quality of life. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation.
Time frame: Baseline and 6 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | Mean change IWQOL Total Score at 6 months | 11.16 units on a scale |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | Mean change IWQOL Total Score at 24 months | 11.83 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | Mean change IWQOL Total Score at 6 months | 11.70 units on a scale |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | Mean change IWQOL Total Score at 24 months | 11.32 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | Mean change IWQOL Total Score at 6 months | 11.73 units on a scale |
| Disease Management (Phone Group Counseling) | Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | Mean change IWQOL Total Score at 24 months | 11.23 units on a scale |
Secondary
Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation
Comparison in percent weight loss from baseline of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.
Time frame: Baseline and 6, 18 and 24 months
Population: Enrolled minus deaths and medical removals.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Fee-for-Service (In Clinic Individual Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 18 months | -3.23 percentage from baseline |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 6 months | -5.58 percentage from baseline |
| Fee-for-Service (In Clinic Individual Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 24 months | -2.48 percentage from baseline |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 18 months | -5.47 percentage from baseline |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 6 months | -8.20 percentage from baseline |
| Patient Centered Medical Home (In Clinic Group Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 24 months | -4.30 percentage from baseline |
| Disease Management (Phone Group Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 6 months | -7.52 percentage from baseline |
| Disease Management (Phone Group Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 24 months | -3.83 percentage from baseline |
| Disease Management (Phone Group Counseling) | Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation | Mean % weight change at 18 months | -5.06 percentage from baseline |