Promoting Successful Weight Loss in Primary Care in Louisiana

Obesity Clinical Trial

— PROPEL  

Official title:

Promoting Successful Weight Loss in Primary Care in Louisiana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561221
• Other study ID #: PBRC 2015-052
• Secondary ID: PCORI#OB-1402-10
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: September 6, 2019

Study information

• Verified date: July 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: September 6, 2019
• Est. primary completion date: September 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Lifestyle Counseling
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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (7)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	Louisiana State University Health Sciences Center in New Orleans, Louisiana State University Health Sciences Center Shreveport, Ochsner Health System, Patient-Centered Outcomes Research Institute, Tulane University, Xavier University of Louisiana.

Country where clinical trial is conducted

United States, 

References & Publications (9)

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 — View Citation

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 — View Citation

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. d — View Citation

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. Cli — View Citation

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 Pri — View Citation

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 — View Citation

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 PROPE — View Citation

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 2 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight (Percent Change)	Body weight is measured in light indoor clothes.	Percent (%) Change from Baseline to Month 24
Secondary	Waist Circumference	Waist circumference is measured mid-way between the iliac crest and the lower rib margin.	Change from Baseline to Month 24
Secondary	Systolic Blood Pressure	Resting systolic blood pressures is measured.	Change from Baseline to Month 24
Secondary	Fasting Plasma Glucose	Glucose is measured in the fasted state with a point-of-care device.	Change from Baseline to Month 24
Secondary	Total Cholesterol	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
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.	Change from Baseline to Month 24
Secondary	Body Weight (Absolute Change)	Body weight is measured in light indoor clothes.	Absolute (kg) Change from Baseline to Month 24
Secondary	Diastolic Blood Pressure	Resting diastolic blood pressures is measured.	Change from Baseline to Month 24
Secondary	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
Secondary	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
Secondary	Triglycerides	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.	Change from Baseline to Month 24