Trial Outcomes & Findings for Promoting Successful Weight Loss in Primary Care in Louisiana (NCT NCT02561221)

NCT ID: NCT02561221

Last Updated: 2023-08-01

Results Overview

Body weight is measured in light indoor clothes.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 803 participants
• Primary outcome timeframe: Percent (%) Change from Baseline to Month 24
• Results posted on: 2023-08-01

Participant Flow

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.

Unit of analysis: Primary care clinics

Participant milestones

Measure	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.	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.
Overall Study STARTED	452 9	351 9
Overall Study Month 6	386 9	340 9
Overall Study Month 12	365 9	326 9
Overall Study Month 18	357 9	316 9
Overall Study COMPLETED	362 9	308 9
Overall Study NOT COMPLETED	90 0	43 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Promoting Successful Weight Loss in Primary Care in Louisiana

Baseline characteristics by cohort

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.	Total n=803 Participants Total of all reporting groups
Age, Continuous	48.8 years STANDARD_DEVIATION 12.7 • n=5 Participants	50.1 years STANDARD_DEVIATION 13.6 • n=7 Participants	49.4 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	398 Participants n=5 Participants	280 Participants n=7 Participants	678 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	71 Participants n=7 Participants	125 Participants n=5 Participants
Race/Ethnicity, Customized African American	332 Participants n=5 Participants	208 Participants n=7 Participants	540 Participants n=5 Participants
Race/Ethnicity, Customized White	95 Participants n=5 Participants	113 Participants n=7 Participants	208 Participants n=5 Participants
Race/Ethnicity, Customized Other	25 Participants n=5 Participants	30 Participants n=7 Participants	55 Participants n=5 Participants
Body Mass Index	37.3 kg/m^2 STANDARD_DEVIATION 4.6 • n=5 Participants	37.2 kg/m^2 STANDARD_DEVIATION 4.8 • n=7 Participants	37.2 kg/m^2 STANDARD_DEVIATION 4.7 • n=5 Participants

PRIMARY outcome

Timeframe: Percent (%) Change from Baseline to Month 24

Body weight is measured in light indoor clothes.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Body Weight (Percent Change)	-4.99 percent change Interval -6.02 to -3.96	-0.48 percent change Interval -1.57 to 0.61

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Waist circumference is measured mid-way between the iliac crest and the lower rib margin.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Waist Circumference	-4.42 cm Interval -5.44 to -3.41	0.71 cm Interval -0.35 to 1.78

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Resting systolic blood pressures is measured.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Systolic Blood Pressure	1.94 mmHg Interval -0.75 to 4.63	0.41 mmHg Interval -2.43 to 3.26

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Glucose is measured in the fasted state with a point-of-care device.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Fasting Plasma Glucose	-1.25 mg/dL Interval -5.65 to 3.15	-0.33 mg/dL Interval -4.61 to 3.94

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Total Cholesterol	4.64 mg/dL Interval 0.45 to 8.82	-1.26 mg/dL Interval -5.38 to 2.87

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function	0.82 score on a scale Interval -0.16 to 1.79	-0.39 score on a scale Interval -1.39 to 0.62

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
PROMIS-29 Anxiety	-0.92 score on a scale Interval -2.29 to 0.46	-0.53 score on a scale Interval -1.95 to 0.89

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
PROMIS-29 Depression	-0.18 score on a scale Interval -1.17 to 0.81	0.64 score on a scale Interval -0.34 to 1.63

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
PROMIS-29 Fatigue	-2.82 score on a scale Interval -4.06 to -1.59	-1.03 score on a scale Interval -2.28 to 0.22

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
PROMIS-29 Sleep Disturbance	-1.25 score on a scale Interval -2.45 to -0.05	-0.35 score on a scale Interval -1.59 to 0.89

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
PROMIS-29 Social Functioning	1.57 score on a scale Interval 0.55 to 2.6	0.15 score on a scale Interval -0.87 to 1.17

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
PROMIS-29 Pain Interference	-1.06 score on a scale Interval -2.22 to 0.1	0.21 score on a scale Interval -0.95 to 1.37

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
PROMIS-29 Pain Intensity	-0.02 units on a scale Interval -0.35 to 0.3	0.21 units on a scale Interval -0.12 to 0.53

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score	11.02 score on a scale Interval 9.04 to 13.0	4.36 score on a scale Interval 2.34 to 6.39

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
IWQOL-L Physical Function	12.31 score on a scale Interval 9.55 to 15.06	4.11 score on a scale Interval 1.24 to 6.97

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
IWQOL-L Self Esteem	14.39 score on a scale Interval 11.66 to 17.12	7.62 score on a scale Interval 4.88 to 10.36

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
IWQOL-L Sexual Life	14.32 score on a scale Interval 11.0 to 17.65	4.49 score on a scale Interval 1.18 to 7.8

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
IWQOL-L Public Distress	5.38 score on a scale Interval 2.86 to 7.89	2.41 score on a scale Interval -0.2 to 5.02

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

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.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
IWQOL-L Work/Daily Activity	5.48 score on a scale Interval 3.22 to 7.75	1.47 score on a scale Interval -0.83 to 3.76

SECONDARY outcome

Timeframe: Absolute (kg) Change from Baseline to Month 24

Body weight is measured in light indoor clothes.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Body Weight (Absolute Change)	-5.43 kg Interval -6.52 to -4.34	-0.91 kg Interval -2.07 to 0.24

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Resting diastolic blood pressures is measured.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Diastolic Blood Pressure	-0.61 mmHg Interval -2.39 to 1.17	-0.64 mmHg Interval -2.53 to 1.24

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
High-density Lipoprotein Cholesterol	4.16 mg/dL Interval 2.78 to 5.54	-0.44 mg/dL Interval -1.81 to 0.94

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Low-density Lipoprotein Cholesterol	3.22 mg/dL Interval -0.85 to 7.29	-0.17 mg/dL Interval -4.17 to 3.83

SECONDARY outcome

Timeframe: Change from Baseline to Month 24

Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

Outcome measures

Measure	Lifestyle Counseling n=452 Participants 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.	Usual Care n=351 Participants 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.
Triglycerides	-11.23 mg/dL Interval -22.02 to -0.44	-5.58 mg/dL Interval -16.39 to 5.23

Adverse Events

Lifestyle Counseling

Serious events: 48 serious events

Other events: 35 other events

Deaths: 2 deaths

Usual Care

Serious events: 35 serious events

Other events: 46 other events

Deaths: 1 deaths

Serious adverse events

Measure	Lifestyle Counseling n=452 participants at risk 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.	Usual Care n=351 participants at risk 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.
Blood and lymphatic system disorders Anemia	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Blood and lymphatic system disorders Low White Blood Cell Count	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Blood and lymphatic system disorders Pulmonary Embolism	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Cardiac disorders Atrial Fibrillation	0.22% 1/452 • Number of events 1 • 24 months	0.85% 3/351 • Number of events 3 • 24 months
Cardiac disorders Myocardial Infarction	0.44% 2/452 • Number of events 2 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Cardiac disorders Angina	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Cardiac disorders Congestive Heart Failure	0.22% 1/452 • Number of events 2 • 24 months	0.00% 0/351 • 24 months
Cardiac disorders Bradycardia	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Cardiac disorders Arrythmia	0.44% 2/452 • Number of events 2 • 24 months	0.00% 0/351 • 24 months
Endocrine disorders Hypothyroidism	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Gastrointestinal disorders Diverticulitis	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Gastrointestinal disorders Gastroenteritis	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Gastrointestinal disorders Stomach Ulcers	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
General disorders Vertigo/Dizziness	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
General disorders Severe Dehydration	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
General disorders Low Electrolytes/Minerals	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Hepatobiliary disorders Gallbladder Issues/Stones	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Infections and infestations Otorhinolaryngological Infection	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Infections and infestations Intestinal Infection	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Infections and infestations Kidney Infection	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Infections and infestations Respiratory System Infection	0.66% 3/452 • Number of events 4 • 24 months	0.57% 2/351 • Number of events 2 • 24 months
Injury, poisoning and procedural complications Allergic Reaction	0.44% 2/452 • Number of events 2 • 24 months	0.57% 2/351 • Number of events 2 • 24 months
Injury, poisoning and procedural complications Broken Bone	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Injury, poisoning and procedural complications Concussion Complications	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Injury, poisoning and procedural complications Mid- or Post-Surgical Complication	0.66% 3/452 • Number of events 3 • 24 months	0.57% 2/351 • Number of events 2 • 24 months
Metabolism and nutrition disorders Hyperglycemic Event	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Metabolism and nutrition disorders Hypoglycemic Event	0.44% 2/452 • Number of events 2 • 24 months	0.00% 0/351 • 24 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Neoplasm	0.66% 3/452 • Number of events 3 • 24 months	0.85% 3/351 • Number of events 3 • 24 months
Nervous system disorders Grand Mal Seizure	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Psychiatric disorders Attempted Suicide	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Renal and urinary disorders Renal Failure	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Reproductive system and breast disorders Enlarged Uterus	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Respiratory, thoracic and mediastinal disorders Asthma Attack	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Surgical and medical procedures Hernia	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Surgical and medical procedures Cholecystectomy	0.22% 1/452 • Number of events 1 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Surgical and medical procedures Penile Implant	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Surgical and medical procedures Hysterectomy	1.1% 5/452 • Number of events 5 • 24 months	0.00% 0/351 • 24 months
Surgical and medical procedures Musculoskeletal Surgery	0.66% 3/452 • Number of events 3 • 24 months	0.57% 2/351 • Number of events 3 • 24 months
Surgical and medical procedures Preventive Brain Bypass Surgery	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Surgical and medical procedures Gastric Sleeve	0.22% 1/452 • Number of events 1 • 24 months	0.00% 0/351 • 24 months
Surgical and medical procedures Cyst Removal	0.00% 0/452 • 24 months	0.57% 2/351 • Number of events 2 • 24 months
Surgical and medical procedures Preventive Mastectomy and Reconstruction	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Surgical and medical procedures Thyroidectomy	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Surgical and medical procedures Heller Myotomy	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Vascular disorders Occlusion	0.66% 3/452 • Number of events 3 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Vascular disorders Hypertensive Event	0.88% 4/452 • Number of events 5 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Vascular disorders Hypotensive Event	0.00% 0/452 • 24 months	0.28% 1/351 • Number of events 1 • 24 months
Vascular disorders Stroke	0.44% 2/452 • Number of events 2 • 24 months	0.57% 2/351 • Number of events 2 • 24 months

Other adverse events

Measure	Lifestyle Counseling n=452 participants at risk 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.	Usual Care n=351 participants at risk 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.
Infections and infestations Otorhinolaryngological Infection	4.4% 20/452 • Number of events 26 • 24 months	7.7% 27/351 • Number of events 35 • 24 months
Infections and infestations Respiratory System Infection	3.3% 15/452 • Number of events 19 • 24 months	5.4% 19/351 • Number of events 23 • 24 months

Additional Information

Dr. Peter T. Katzmarzyk, Associate Executive Director of Population and Public Health Sciences

Pennington Biomedical Research Center

Phone: 225-763-2536

Email: doctors@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place