Promoting Successful Weight Loss in Primary Care in Louisiana

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Promoting Successful Weight Loss in Primary Care in Louisiana

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Lifestyle Counseling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 20.0 - 75.0 years BMI 30.0 - 50.0 kg/m2 Able to provide written informed consent Willing to change diet, physical activity and weight Patient of a participating clinic Able to participate in scheduled sessions Exclusion Criteria: Currently participating in a weight loss program Current use of weight loss medication or recent weight loss (>10 lbs in last 6 months) Plans to move from the area within 2 years Given birth within the past year, is currently pregnant or plans to become pregnant within 2 years Past bariatric surgery or plans for bariatric surgery within 2 years Current major depression History of suicidal behavior or diagnosed eating disorder (bulimia, anorexia) Hospitalization for mental disorder or substance abuse in the previous year Active cancer (except prostate, skin and thyroid if approved by physician) Serious arrhythmias or cardiomyopathy Severe congestive heart failure Stroke or heart attack in previous six months Chronic Inflammatory conditions, including but not limited to severe arthritis, lupus, or inflammatory bowel disease(i.e. Crohn's disease or ulcerative colitis) Disease that is life threatening or that can interfere with or be aggravated by exercise or weight loss Discretion of primary care physician or principal investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle Counseling<br>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. | Behavioral: Lifestyle Counseling<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight (Percent Change) | Body weight is measured in light indoor clothes. | Percent (%) Change from Baseline to Month 24 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary care, pragmatic trial, weight loss, overweight, diet, physical activity, PCORI