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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-1402-09413 | Other Grant/Funding Number | Patient-Centered Outcomes Research Institute | |
| STUDY00002654 | Other Identifier | KUMC IRB |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fee-for-Service Model (FFS, In clinic individual visits) | Active Comparator | Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. |
|
| Patient Centered Medical Home (PCMH, In clinic group visits) | Active Comparator | 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. |
|
| Disease Management (DM, Phone group visits) | Active Comparator | Participants will take part in group weight-management counseling by telephone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fee-for-Service Model (FFS, In clinic individual visits) | Behavioral | To be performed by participant's doctor or other healthcare professional in their doctor's office. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6, 18 and 24 months |
| 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. | Baseline and 6, 18 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christie Befort, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42420235 | Derived | Bernal J, Wick JA, Gajewski B, Greiner KA, Wu J, Befort C. Weight-Related Self-Esteem, Group Behavioral Therapy, and Weight Loss. Obesity (Silver Spring). 2026 Jul 8. doi: 10.1002/oby.70257. Online ahead of print. | |
| 35398370 | Derived | Saint Onge JM, Fagan M, Befort CA. The association between the obesogenic environment and 6-month and 24-month weight change in a rural weight loss intervention trial in the United States. Prev Med. 2022 May;158:107040. doi: 10.1016/j.ypmed.2022.107040. Epub 2022 Apr 7. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled minus deaths and medical removals
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Enrolled minus deaths and medical removals. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 97.5% Confidence Interval | kg | Baseline and 6, 18 and 24 months |
|
Serious adverse events (SAEs), to include deaths, were collected for each participant over an approximate two year period, from enrollment through the final study visit at 24 months.
Only SAEs were captured for the study per approval of the overseeing Institutional Review Board (IRB) and the study Data Safety and Monitoring Board (DSMB). SAEs were identified during data collection visits at 6, 18 and 24 months, and via participant self-report surveys at 6, 12, 18 and 24 months. SAEs were also identified ad hoc via reporting by participants during study counseling sessions and during standard care clinic activities at each site.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fee-for-Service (FFS; 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christie Befort, PhD | University of Kansas Medical Center | 913 588-3338 | cbefort@kumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2020 | Jun 16, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D003920 | Diabetes Mellitus |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019468 | Disease Management |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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|
| Patient Centered Medical Home (PCMH, In clinic group visits) | Behavioral | To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting. |
|
|
| Disease Management (DM, Phone group visits) | Behavioral | To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone. |
|
|
| Baseline and 6, 18 and 24 months |
| 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. | Baseline and 6, 18 and 24 months |
| 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. | Baseline and 6, 18 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6 and 24 months |
| 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. | Baseline and 6, 18 and 24 months |
| 35081912 | Derived | Tang F, Befort CA, Wick J, Gajewski BJ. Unifying the analysis of continuous and categorical measures of weight loss and incorporating group effect: a secondary re-analysis of a large cluster randomized clinical trial using Bayesian approach. BMC Med Res Methodol. 2022 Jan 26;22(1):28. doi: 10.1186/s12874-021-01499-0. |
| 34714976 | Derived | Katzmarzyk PT, Apolzan JW, Gajewski B, Johnson WD, Martin CK, Newton RL Jr, Perri MG, VanWormer JJ, Befort CA. Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials. Obesity (Silver Spring). 2021 Dec;29(12):2044-2054. doi: 10.1002/oby.23292. Epub 2021 Oct 29. |
| 34175347 | Derived | Goessl CL, VanWormer JJ, Pathak RD, Ellerbeck EF, Befort CA. Affective disorders, weight change, and patient engagement in a rural behavioral weight loss trial. Prev Med. 2021 Nov;152(Pt 2):106698. doi: 10.1016/j.ypmed.2021.106698. Epub 2021 Jun 24. |
| 33496775 | Derived | Befort CA, VanWormer JJ, Desouza C, Ellerbeck EF, Gajewski B, Kimminau KS, Greiner KA, Perri MG, Brown AR, Pathak RD, Huang TT, Eiland L, Drincic A. Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial. JAMA. 2021 Jan 26;325(4):363-372. doi: 10.1001/jama.2020.25855. |
| 32126987 | Derived | Befort CA, Kurz D, VanWormer JJ, Ellerbeck EF. Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: implications for real-world primary care practice. BMC Fam Pract. 2020 Mar 3;21(1):47. doi: 10.1186/s12875-020-01117-w. |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| 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. |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Enrolled minus deaths and medical removals. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Enrolled minus deaths and medical removals. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Enrolled minus deaths and medical removals. | Count of Participants | Participants |
|
| Region of Enrollment | Enrolled minus deaths and medical removals. | Count of Participants | Participants |
|
| Weight, kg | Enrolled minus deaths and medical removals | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Enrolled minus deaths and medical removals. | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
| OG002 | 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 |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 97.5% Confidence Interval | kg | Baseline and 6, 18 and 24 months |
|
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | percentage from baseline | Baseline and 6, 18 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline and 6, 18 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | mmHg | Baseline and 6, 18 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6 and 24 months |
|
|
|
| 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. | Enrolled minus deaths and medical removals. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 6, 18 and 24 months |
|
|
|
| 0 |
| 478 |
| 94 |
| 478 |
| 0 |
| 478 |
| EG001 | Patient Centered Medical Home(PCMH;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. | 3 | 479 | 88 | 479 | 0 | 479 |
| EG002 | Disease Management (DM; 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 | 0 | 475 | 82 | 475 | 0 | 475 |
| Myelofibrosis, bone marrow transplant | Blood and lymphatic system disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation with rapid ventricular response | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation with rapid ventricular response, ablation | Cardiac disorders | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | Systematic Assessment |
|
| Cardiac arrest, secondary to ventricular fibrillation | Cardiac disorders | Systematic Assessment |
|
| Chest pain, cardiac, cardiac catheterization | Cardiac disorders | Systematic Assessment |
|
| Chest pain, cardiac, myocardial infarction ruled out | Cardiac disorders | Systematic Assessment |
|
| Chest pain, cardiac, unspecified EKG changes | Cardiac disorders | Systematic Assessment |
|
| Chest pain, etiology unkown, myocardial infaction ruled out | Cardiac disorders | Systematic Assessment |
|
| Chest pain, non-cardiac | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease, coronary artery bypass graft | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease, heart catheterizatrion | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease, heart catheterizatrion, stent placement | Cardiac disorders | Systematic Assessment |
|
| Coronary artery disease, occluded stent, cardiac catheterization | Cardiac disorders | Systematic Assessment |
|
| Heart palpitations | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction, cardiac catheterization, stent placement | Cardiac disorders | Systematic Assessment |
|
| Myocardial Infarction, coronary artery bypass graft | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction, Non-ST-elevation, cardiac catheterization | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Tachycardia, supraventricular | Cardiac disorders | Systematic Assessment |
|
| Congential scoliosis, broken rod, type unspecified, surgical repair | Congenital, familial and genetic disorders | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Enlarged thyroid, benign, partial thyroidectomy | Endocrine disorders | Systematic Assessment |
|
| Hyperthyroidism, total thyroidectomy | Endocrine disorders | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | Systematic Assessment |
|
| Multinodular goiter, total thyroidectomy | Endocrine disorders | Systematic Assessment |
|
| Abdominal pain, chronic | Gastrointestinal disorders | Systematic Assessment |
|
| Appendicitis | Gastrointestinal disorders | Systematic Assessment |
|
| Clostridium difficile colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Cystic fibrosis exacerbation | Gastrointestinal disorders | Systematic Assessment |
|
| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
|
| Diverticulosis | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal reflux disesase | Gastrointestinal disorders | Systematic Assessment |
|
| Gastrointestinal bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Hernia, hiatal, surgical repair | Gastrointestinal disorders | Systematic Assessment |
|
| Hernia, incisional, surgical repair | Gastrointestinal disorders | Systematic Assessment |
|
| Hernia, inguinal, surgical repair | Gastrointestinal disorders | Systematic Assessment |
|
| Hernia, umbilical, surgical repair | Gastrointestinal disorders | Systematic Assessment |
|
| Hernia, unspecified, surgical repair | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea, vomiting, intractable | Gastrointestinal disorders | Systematic Assessment |
|
| Small bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Withdrawal reaction, acute, baclofen | General disorders | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
|
| Cholelithiasis, cholecysytectomy | Hepatobiliary disorders | Systematic Assessment |
|
| Cholestasis | Hepatobiliary disorders | Systematic Assessment |
|
| Allergic reaction, bee sting | Immune system disorders | Systematic Assessment |
|
| Allergic reaction, severe, etiology unspecified | Immune system disorders | Systematic Assessment |
|
| Anaphylaxis, medication, not specified | Immune system disorders | Systematic Assessment |
|
| Medication reaction, IV contrast, chest pain | Immune system disorders | Systematic Assessment |
|
| Multiple sclerosis, exacerbation | Immune system disorders | Systematic Assessment |
|
| Acute febrile illness | Infections and infestations | Systematic Assessment |
|
| Cellulitis, location not specified, post cat bile | Infections and infestations | Systematic Assessment |
|
| Cellulitis, lower extermity | Infections and infestations | Systematic Assessment |
|
| Cellulitis, mastectomy wound | Infections and infestations | Systematic Assessment |
|
| Cellulitis, preauricular | Infections and infestations | Systematic Assessment |
|
| Cellulitis, upper extremity | Infections and infestations | Systematic Assessment |
|
| Infection, leg wound | Infections and infestations | Systematic Assessment |
|
| Infection, pacemaker | Infections and infestations | Systematic Assessment |
|
| Infection, pericarditis | Infections and infestations | Systematic Assessment |
|
| Infection, periprosthetic, knee arthroplasty | Infections and infestations | Systematic Assessment |
|
| Infection, toe wound | Infections and infestations | Systematic Assessment |
|
| Infection, urinary tract | Infections and infestations | Systematic Assessment |
|
| Lyme disease | Infections and infestations | Systematic Assessment |
|
| Sepsis, secondary to Group A strep infection | Infections and infestations | Systematic Assessment |
|
| Sepsis, secondary to influenza | Infections and infestations | Systematic Assessment |
|
| Sepsis, secondary to pneumonia | Infections and infestations | Systematic Assessment |
|
| Sepsis, secondary to urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dehydration, severe | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Achilles tendon injury, surgical repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain, laminectomy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bunion, bunionectomy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cervical Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Charcot arthropathy, foot, surgical repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dislocation, internal hip prosthesis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture, ankle, surgical repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture, humerus | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture, knee, arthroplasty | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Fracture, ribs | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Injury, unspecifed, ankle, surgical repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Knee pain, arthroscopy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lumbar degenerative disc disease, decompression surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lumbar degenerative disc disease, decompression, fusion surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis, cervical spine | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis, cervical spine, discectomy, fusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis, hip, arthoplasty | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis, knee, arthroplasty | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis, knee, arthroplasty revision | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis, knee, arthroplasty, bilateral | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteoarthritis, rotator cuff tear, shoulder, arthroplasty | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteomyelitis, ankle, surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Osteomyelitis, shoulder, arthoplasty revision | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pain, ankle, arthroplasty revision | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Rib pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ruptured cervical vertebrae, surgical repair | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Adenomatoid nodule, partial thyroidectomy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cancer, lung, non-small cell | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cancer, prostate | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cancer, prostate, prostatectomy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cancer, renal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cancer, thyroid, total thyroidectomy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Cancer, uterine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Subdural hematoma | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Gunshot wound, self-inflicted | Psychiatric disorders | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Pyleonephritis, acute | Renal and urinary disorders | Systematic Assessment |
|
| Renal failure, acute | Renal and urinary disorders | Systematic Assessment |
|
| Renal insufficency | Renal and urinary disorders | Systematic Assessment |
|
| Renal lithiasis | Renal and urinary disorders | Systematic Assessment |
|
| Chronic endocervicitis, paratubal cysts, hysterectomy, bilateral salpingo-oophorectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| Erectile dysfunction, penile implant | Reproductive system and breast disorders | Systematic Assessment |
|
| Fallopian tube torsion, surgical repair | Reproductive system and breast disorders | Systematic Assessment |
|
| Menorrhagia | Reproductive system and breast disorders | Systematic Assessment |
|
| Menorrhagia, Hysterectomy | Reproductive system and breast disorders | Systematic Assessment |
|
| Menorrhagia, hysterectomy, recotocele repair | Reproductive system and breast disorders | Systematic Assessment |
|
| Pelvic floor injury, hysterectomy, bladder sling | Reproductive system and breast disorders | Systematic Assessment |
|
| Post-hysterectomy prolapse, surgical repair | Reproductive system and breast disorders | Systematic Assessment |
|
| Tubo-ovarian abscess | Reproductive system and breast disorders | Systematic Assessment |
|
| Uterine leiomyoma | Reproductive system and breast disorders | Systematic Assessment |
|
| Chronic obstructive pulmonary disease, exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Influenza | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonitis, interstitial | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure, acute | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure, acute, secondary to bilateral pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure, acute, secondary to Influenza B | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tonsilitis, tonsillectomy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tonsillar hemorrhage, post tonsillectomy | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Obesity Gastric Bypass | Surgical and medical procedures | Systematic Assessment |
|
| Abdominal aortic aneurysm | Vascular disorders | Systematic Assessment |
|
| Capillary hemorrhage, leg | Vascular disorders | Systematic Assessment |
|
| Cerebrovascular accident | Vascular disorders | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
|
| Hemorrhage, subarachnoid | Vascular disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Hypertensive urgency | Vascular disorders | Systematic Assessment |
|
| Pulmonary embolus | Vascular disorders | Systematic Assessment |
|
| Stroke-like symptoms | Vascular disorders | Systematic Assessment |
|
| Syncope | Vascular disorders | Systematic Assessment |
|
| Syncope, near | Vascular disorders | Systematic Assessment |
|
| Syncope, recurrent | Vascular disorders | Systematic Assessment |
|
| Transient ischemic attack | Vascular disorders | Systematic Assessment |
|
| Uncontrolled bleeding, post transurethral prostatectomy | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D002318 | Cardiovascular Diseases |
| Mean weight change at 18 months |
|
| Mean weight change at 24 months |
|
| Mixed Models Analysis |
| .025 |
| Median Difference (Net) |
| -1.34 |
| 2-Sided |
| 97.5 |
| -2.99 |
| 0.32 |
| Superiority |
| PCMH (in clinic group counseling) versus DM (phone group counseling) | Mixed Models Analysis | .025 | Mean Difference (Net) | -0.50 | 2-Sided | 97.5 | -2.15 | 1.15 | Superiority |
| Mean % weight change at 18 months |
|
| Mean % weight change at 24 months |
|
| Mean change Systolic BP at 18 months |
|
| Mean change Systolic BP at 24 months |
|
| Mean change Diastolic BP at 18 months |
|
| Mean change Diastolic BP at 24 months |
|
| Mean change fasting glucose at 24 months |
|
| Mean change fasting cholesterol at 24 months |
|
| Mean change fasting triglycerides at 24 months |
|
| Mean change fasting LDL at 24 months |
|
| Mean change fasting HDL at 24 months |
|
| Mean change SF-12 Physical Score at 24 months |
|
| Mean change SF-12 Mental Score at 24 months |
|
| Mean change IWQOL Total Score at 24 months |
|
| Mean Change PSQI Score at 24 months |
|
| Mean change in PSS Score at 18 months |
|
| Mean change in PSS Score at 24 months |
|