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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI#OB-1402-10977 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| Louisiana State University Health Sciences Center Shreveport | OTHER |
| Tulane University | OTHER |
| Ochsner Health System | OTHER |
| Louisiana State University Health Sciences Center in New Orleans |
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The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Half of the clinics received a behavioral intervention delivered in a primary care setting and half of the clinics received usual care.
This study is a cluster-randomized, two-arm controlled trial in primary care settings. A total of 18 primary care clinics inclusive of low income populations with a high percentage of African Americans from urban and rural areas across Louisiana were randomized to either 1) intervention or 2) usual care. The sample includes 803 patients with obesity (BMI 30-50 kg/m2) (18 clinics, median of 40.5 patients / clinic). The primary aim of this trial is to develop and test the effectiveness of a 24 month, patient-centered, pragmatic and scalable obesity treatment program delivered within primary care, inclusive of an underserved population. Patients in the intervention arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the intervention arm received a series of webinars on obesity science to help them manage and treat obese patients. Patients assigned to the usual care arm will continue to interact with their Primary Care Practitioner according to their usual schedule, and will receive a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid Services (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure will be sent to the Primary Care Practitioners each year. Patients in both arms were assessed on primary and secondary outcome measures at baseline, and at 6, 12, 18 and 24 months of intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Counseling | Experimental | Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. |
|
| Usual Care | No Intervention | Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Counseling | Behavioral | Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight (Percent Change) | Body weight is measured in light indoor clothes. | Percent (%) Change from Baseline to Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference | Waist circumference is measured mid-way between the iliac crest and the lower rib margin. | Change from Baseline to Month 24 |
| Systolic Blood Pressure | Resting systolic blood pressures is measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter T Katzmarzyk, PhD | Pennington Biomedical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29408562 | Result | Katzmarzyk PT, Martin CK, Newton RL Jr, Apolzan JW, Arnold CL, Davis TC, Denstel KD, Mire EF, Thethi TK, Brantley PJ, Johnson WD, Fonseca V, Gugel J, Kennedy KB, Lavie CJ, Price-Haywood EG, Sarpong DF, Springgate B. Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics. Contemp Clin Trials. 2018 Apr;67:1-10. doi: 10.1016/j.cct.2018.02.002. Epub 2018 Feb 8. | |
| 31248113 |
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A de-identified individual-level dataset will be made available to researchers making a reasonable request and upon approval of the PROPEL Publications Committee. Data will be made available 1 year after publication of the primary outcomes manuscript. A data sharing statement and the protocol are available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2007448
Data will be made available upon reasonable request to the Principal Investigator 1 year after the publication of the Primary Outcomes manuscript.
Access to the data must be approved by the PROPEL Publications Committee.
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Eighteen primary care clinics were randomized equally to either the Intensive Lifestyle Intervention or Usual Care. Patients received the intervention to which their clinic was assigned. Study enrollment occurred from April 2016 to September 2017. Patients completed a pre-screener and attended a screening visit which included the consent process and measurement to determine height and weight for BMI among other eligibility criteria. Patients were enrolled upon baseline visit completion.
| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Counseling | Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines. |
| FG001 | Usual Care | Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Counseling | Patients in the Lifestyle Counseling Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Body Weight (Percent Change) | Body weight is measured in light indoor clothes. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | Percent (%) Change from Baseline to Month 24 |
|
24 months
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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 | Lifestyle Counseling | Patients in the Intensive Lifestyle Intervention Arm attended weekly (16 in-person) sessions in the first six months, followed by monthly sessions for the remaining 18 months. The behavioral intervention was delivered by a trained health coach embedded in the primary care clinic. Primary Care Practitioners in the experimental arm received a series of webinars on obesity science to help them manage and treat patients with obesity. Intensive Lifestyle Intervention: Trained health coaches delivered the active intervention - a comprehensive, "high-intensity" program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otorhinolaryngological Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter T. Katzmarzyk, Associate Executive Director of Population and Public Health Sciences | Pennington Biomedical Research Center | 225-763-2536 | doctors@pbrc.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 | Apr 6, 2020 | Oct 19, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D050177 | Overweight |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| OTHER |
| Xavier University of Louisiana. | OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
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| Change from Baseline to Month 24 |
| Fasting Plasma Glucose | Glucose is measured in the fasted state with a point-of-care device. | Change from Baseline to Month 24 |
| Total Cholesterol | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Change from Baseline to Month 24 |
| Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function | The PROMIS-29 physical function sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| PROMIS-29 Anxiety | The PROMIS-29 Anxiety sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| PROMIS-29 Depression | The PROMIS-29 Depression sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| PROMIS-29 Fatigue | The PROMIS-29 Fatigue sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| PROMIS-29 Sleep Disturbance | The PROMIS-29 sleep disturbance sub-scale includes 4 questions and scores ranges from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| PROMIS-29 Social Functioning | The PROMIS-29 social roles sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| PROMIS-29 Pain Interference | The PROMIS-29 pain interference sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| PROMIS-29 Pain Intensity | The PROMIS-29 pain intensity sub-scale includes 1 question and scores range from 1 to 10 (higher values represent a worse outcome). A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Change from Baseline to Month 24 |
| Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score | 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. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The total transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Change from Baseline to Month 24 |
| IWQOL-L Physical Function | The IWQOL-L physical function sub-scale includes 11 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Change from Baseline to Month 24 |
| IWQOL-L Self Esteem | The IWQOL-L self-esteem sub-scale includes 7 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Change from Baseline to Month 24 |
| IWQOL-L Sexual Life | The IWQOL-L sexual life sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Change from Baseline to Month 24 |
| IWQOL-L Public Distress | The IWQOL-L public distress sub-scale includes 5 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Change from Baseline to Month 24 |
| IWQOL-L Work/Daily Activity | The IWQOL-L work/daily activity sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Change from Baseline to Month 24 |
| Body Weight (Absolute Change) | Body weight is measured in light indoor clothes. | Absolute (kg) Change from Baseline to Month 24 |
| Diastolic Blood Pressure | Resting diastolic blood pressures is measured. | Change from Baseline to Month 24 |
| High-density Lipoprotein Cholesterol | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Change from Baseline to Month 24 |
| Low-density Lipoprotein Cholesterol | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Change from Baseline to Month 24 |
| Triglycerides | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Change from Baseline to Month 24 |
| Result |
| Myers CA, Martin CK, Newton RL Jr, Apolzan JW, Arnold CL, Davis TC, Price-Haywood EG, Katzmarzyk PT. Cardiovascular Health, Adiposity, and Food Insecurity in an Underserved Population. Nutrients. 2019 Jun 19;11(6):1376. doi: 10.3390/nu11061376. |
| 32877581 | Result | Katzmarzyk PT, Martin CK, Newton RL Jr, Apolzan JW, Arnold CL, Davis TC, Price-Haywood EG, Denstel KD, Mire EF, Thethi TK, Brantley PJ, Johnson WD, Fonseca V, Gugel J, Kennedy KB, Lavie CJ, Sarpong DF, Springgate B. Weight Loss in Underserved Patients - A Cluster-Randomized Trial. N Engl J Med. 2020 Sep 3;383(10):909-918. doi: 10.1056/NEJMoa2007448. |
| 33557578 | Result | Hochsmann C, Dorling JL, Martin CK, Newton RL Jr, Apolzan JW, Myers CA, Denstel KD, Mire EF, Johnson WD, Zhang D, Arnold CL, Davis TC, Fonseca V, Lavie CJ, Price-Haywood EG, Katzmarzyk PT; PROPEL Research Group. Effects of a 2-Year Primary Care Lifestyle Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial. Circulation. 2021 Mar 23;143(12):1202-1214. doi: 10.1161/CIRCULATIONAHA.120.051328. Epub 2021 Feb 9. |
| 35762659 | Result | Dorling JL, Martin CK, Yu Q, Cao W, Hochsmann C, Apolzan JW, Newton RL, Denstel KD, Mire EF, Katzmarzyk PT. Mediators of weight change in underserved patients with obesity: exploratory analyses from the Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL) cluster-randomized trial. Am J Clin Nutr. 2022 Oct 6;116(4):1112-1122. doi: 10.1093/ajcn/nqac179. |
| 35523955 | Result | Katzmarzyk PT, Mire EF, Martin CK, Newton RL Jr, Apolzan JW, Price-Haywood EG, Denstel KD, Horswell R, Chu ST, Johnson WD; PROPEL Research Group. Comparison of weight loss data collected by research technicians versus electronic medical records: the PROPEL trial. Int J Obes (Lond). 2022 Aug;46(8):1456-1462. doi: 10.1038/s41366-022-01129-9. Epub 2022 May 6. |
| 35412010 | Result | Katzmarzyk PT, Denstel KD, Martin CK, Newton RL Jr, Apolzan JW, Mire EF, Horswell R, Johnson WD, Brown AW, Zhang D; PROPEL Research Group. Intraclass correlation coefficients for weight loss cluster randomized trials in primary care: The PROPEL trial. Clin Obes. 2022 Aug;12(4):e12524. doi: 10.1111/cob.12524. Epub 2022 Apr 12. |
| 34714976 | Result | 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. |
| 36702913 | Result | Katzmarzyk PT, Mire EF, Martin CK, Newton RL, Apolzan JW, Denstel KD, Johnson WD; PROPEL Research Group. Physical activity and weight loss in a pragmatic weight loss trial. Int J Obes (Lond). 2023 Mar;47(3):244-248. doi: 10.1038/s41366-023-01260-1. Epub 2023 Jan 26. |
| 41934285 | Derived | Denstel KD, Mire EF, Martin CK, Apolzan JW, Arnold CL, Davis TC, Lavie CJ, Newton RL Jr, Zhang D, Price-Haywood EG, Katzmarzyk PT; PROPEL Research Group. Effects of a 2-Year Primary Care Weight Loss Intervention on Quality of Life in Patients With Obesity. Obesity (Silver Spring). 2026 May;34(5):1032-1044. doi: 10.1002/oby.70189. Epub 2026 Apr 4. |
| 39429541 | Derived | Katzmarzyk PT, Mire EF, Horswell R, Chu ST, Zhang D, Martin CK, Newton RL, Apolzan JW, Price-Haywood EG, Fort D, Carton TW, Denstel KD; PROPEL Research Group. Four-year follow-up of weight loss maintenance using electronic medical record data: The PROPEL trial. Obes Sci Pract. 2024 Oct 19;10(5):e70017. doi: 10.1002/osp4.70017. eCollection 2024 Oct. |
| 37551762 | Derived | Hochsmann C, Martin CK, Apolzan JW, Dorling JL, Newton RL Jr, Denstel KD, Mire EF, Johnson WD, Zhang D, Arnold CL, Davis TC, Fonseca V, Thethi TK, Lavie CJ, Springgate B, Katzmarzyk PT; PROPEL Research Group. Initial weight loss and early intervention adherence predict long-term weight loss during the Promoting Successful Weight Loss in Primary Care in Louisiana lifestyle intervention. Obesity (Silver Spring). 2023 Sep;31(9):2272-2282. doi: 10.1002/oby.23854. Epub 2023 Aug 8. |
| 37528391 | Derived | Apolzan JW, Martin CK, Newton RL Jr, Myers CA, Arnold CL, Davis TC, Johnson WD, Zhang D, Hochsmann C, Fonseca VA, Denstel KD, Mire EF, Springgate BF, Lavie CJ, Katzmarzyk PT; PROPEL Research Group. Dietary intake during a pragmatic cluster-randomized weight loss trial in an underserved population in primary care. Nutr J. 2023 Aug 2;22(1):38. doi: 10.1186/s12937-023-00864-7. |
| BG001 | Usual Care | Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual health care schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | Usual Care | Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year. |
|
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| Secondary | Waist Circumference | Waist circumference is measured mid-way between the iliac crest and the lower rib margin. | Posted | Least Squares Mean | 95% Confidence Interval | cm | Change from Baseline to Month 24 |
|
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| Secondary | Systolic Blood Pressure | Resting systolic blood pressures is measured. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Change from Baseline to Month 24 |
|
|
|
| Secondary | Fasting Plasma Glucose | Glucose is measured in the fasted state with a point-of-care device. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Change from Baseline to Month 24 |
|
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|
| Secondary | Total Cholesterol | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Change from Baseline to Month 24 |
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|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function | The PROMIS-29 physical function sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
|
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| Secondary | PROMIS-29 Anxiety | The PROMIS-29 Anxiety sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | PROMIS-29 Depression | The PROMIS-29 Depression sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | PROMIS-29 Fatigue | The PROMIS-29 Fatigue sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | PROMIS-29 Sleep Disturbance | The PROMIS-29 sleep disturbance sub-scale includes 4 questions and scores ranges from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | PROMIS-29 Social Functioning | The PROMIS-29 social roles sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a better outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A positive change score indicates improvement while a negative change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | PROMIS-29 Pain Interference | The PROMIS-29 pain interference sub-scale includes 4 questions and scores range from 4 to 20 (higher values represent a worse outcome). Transformed scores were used in analysis. Norm-based scores were calculated so that a score of 50 represents the mean or average of the reference population. The T-score rescales the raw score into a standardized T-score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | PROMIS-29 Pain Intensity | The PROMIS-29 pain intensity sub-scale includes 1 question and scores range from 1 to 10 (higher values represent a worse outcome). A negative change score indicates improvement while a positive change score indicates worsening from baseline. | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Change from Baseline to Month 24 |
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| Secondary | Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score | 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. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The total transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | IWQOL-L Physical Function | The IWQOL-L physical function sub-scale includes 11 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | IWQOL-L Self Esteem | The IWQOL-L self-esteem sub-scale includes 7 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | IWQOL-L Sexual Life | The IWQOL-L sexual life sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | IWQOL-L Public Distress | The IWQOL-L public distress sub-scale includes 5 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | IWQOL-L Work/Daily Activity | The IWQOL-L work/daily activity sub-scale includes 4 questions. Transformed scores used in analyses were calculated so that scores are on a scale of 0 to 100. The transformed score ranges from 0 to 100 with higher change scores indicating greater improvement from Baseline. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from Baseline to Month 24 |
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| Secondary | Body Weight (Absolute Change) | Body weight is measured in light indoor clothes. | Posted | Least Squares Mean | 95% Confidence Interval | kg | Absolute (kg) Change from Baseline to Month 24 |
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| Secondary | Diastolic Blood Pressure | Resting diastolic blood pressures is measured. | Posted | Least Squares Mean | 95% Confidence Interval | mmHg | Change from Baseline to Month 24 |
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| Secondary | High-density Lipoprotein Cholesterol | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Change from Baseline to Month 24 |
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| Secondary | Low-density Lipoprotein Cholesterol | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Change from Baseline to Month 24 |
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| Secondary | Triglycerides | Blood lipids/cholesterol are measured in the fasted state with a point-of-care device. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Change from Baseline to Month 24 |
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| 2 |
| 452 |
| 48 |
| 452 |
| 35 |
| 452 |
| EG001 | Usual Care | Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual schedule, and received a series of newsletters on topics of interest, including importance of sleep for health, brain and memory health, goal setting, smoking cessation, etc. Primary Care Practitioners in the usual care arm received a webinar describing the current Centers for Medicare and Medicaid (CMS) approach to reimbursing for obesity treatment, and a reminder informational brochure was sent to the Primary Care Practitioners each year. | 1 | 351 | 35 | 351 | 46 | 351 |
| Low White Blood Cell Count | Blood and lymphatic system disorders | Systematic Assessment |
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| Pulmonary Embolism | Blood and lymphatic system disorders | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Angina | Cardiac disorders | Systematic Assessment |
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| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
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| Bradycardia | Cardiac disorders | Systematic Assessment |
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| Arrythmia | Cardiac disorders | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | Systematic Assessment |
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| Diverticulitis | Gastrointestinal disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
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| Stomach Ulcers | Gastrointestinal disorders | Systematic Assessment |
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| Vertigo/Dizziness | General disorders | Systematic Assessment |
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| Severe Dehydration | General disorders | Systematic Assessment |
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| Low Electrolytes/Minerals | General disorders | Systematic Assessment |
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| Gallbladder Issues/Stones | Hepatobiliary disorders | Systematic Assessment |
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| Otorhinolaryngological Infection | Infections and infestations | Systematic Assessment |
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| Intestinal Infection | Infections and infestations | Systematic Assessment |
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| Kidney Infection | Infections and infestations | Systematic Assessment |
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| Respiratory System Infection | Infections and infestations | Systematic Assessment |
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| Allergic Reaction | Injury, poisoning and procedural complications | Systematic Assessment |
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| Broken Bone | Injury, poisoning and procedural complications | Systematic Assessment |
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| Concussion Complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Mid- or Post-Surgical Complication | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hyperglycemic Event | Metabolism and nutrition disorders | Systematic Assessment |
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| Hypoglycemic Event | Metabolism and nutrition disorders | Systematic Assessment |
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| Malignant Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Grand Mal Seizure | Nervous system disorders | Systematic Assessment |
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| Attempted Suicide | Psychiatric disorders | Systematic Assessment |
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| Renal Failure | Renal and urinary disorders | Systematic Assessment |
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| Enlarged Uterus | Reproductive system and breast disorders | Systematic Assessment |
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| Asthma Attack | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hernia | Surgical and medical procedures | Systematic Assessment |
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| Cholecystectomy | Surgical and medical procedures | Systematic Assessment |
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| Penile Implant | Surgical and medical procedures | Systematic Assessment |
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| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
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| Musculoskeletal Surgery | Surgical and medical procedures | Systematic Assessment |
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| Preventive Brain Bypass Surgery | Surgical and medical procedures | Systematic Assessment |
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| Gastric Sleeve | Surgical and medical procedures | Systematic Assessment |
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| Cyst Removal | Surgical and medical procedures | Systematic Assessment |
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| Preventive Mastectomy and Reconstruction | Surgical and medical procedures | Systematic Assessment |
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| Thyroidectomy | Surgical and medical procedures | Systematic Assessment |
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| Heller Myotomy | Surgical and medical procedures | Systematic Assessment |
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| Occlusion | Vascular disorders | Systematic Assessment |
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| Hypertensive Event | Vascular disorders | Systematic Assessment |
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| Hypotensive Event | Vascular disorders | Systematic Assessment |
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| Stroke | Vascular disorders | Systematic Assessment |
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| Respiratory System Infection | Infections and infestations | Systematic Assessment |
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Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |