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Promoting Successful Weight Loss in Primary Care in Louisiana (PROPEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02561221
Recruitment Status : Completed
First Posted : September 25, 2015
Results First Posted : December 10, 2020
Last Update Posted : July 26, 2021
Sponsor:
Collaborators:
Louisiana State University Health Sciences Center Shreveport
Tulane University
Ochsner Health System
Louisiana State University Health Sciences Center in New Orleans
Xavier University of Louisiana.
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Peter T. Katzmarzyk, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Lifestyle Counseling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 803 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promoting Successful Weight Loss in Primary Care in Louisiana
Study Start Date : April 2016
Actual Primary Completion Date : September 6, 2019
Actual Study Completion Date : September 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

No Intervention: 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.



Primary Outcome Measures :
  1. Body Weight (Percent Change) [ Time Frame: Percent (%) Change from Baseline to Month 24 ]
    Body weight is measured in light indoor clothes.


Secondary Outcome Measures :
  1. Waist Circumference [ Time Frame: Change from Baseline to Month 24 ]
    Waist circumference is measured mid-way between the iliac crest and the lower rib margin.

  2. Systolic Blood Pressure [ Time Frame: Change from Baseline to Month 24 ]
    Resting systolic blood pressures is measured.

  3. Fasting Plasma Glucose [ Time Frame: Change from Baseline to Month 24 ]
    Glucose is measured in the fasted state with a point-of-care device.

  4. Total Cholesterol [ Time Frame: Change from Baseline to Month 24 ]
    Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

  5. Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function [ Time Frame: 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.

  6. PROMIS-29 Anxiety [ Time Frame: 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.

  7. PROMIS-29 Depression [ Time Frame: 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.

  8. PROMIS-29 Fatigue [ Time Frame: 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.

  9. PROMIS-29 Sleep Disturbance [ Time Frame: 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.

  10. PROMIS-29 Social Functioning [ Time Frame: 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.

  11. PROMIS-29 Pain Interference [ Time Frame: 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.

  12. PROMIS-29 Pain Intensity [ Time Frame: 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.

  13. Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score [ Time Frame: 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.

  14. IWQOL-L Physical Function [ Time Frame: 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.

  15. IWQOL-L Self Esteem [ Time Frame: 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.

  16. IWQOL-L Sexual Life [ Time Frame: 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.

  17. IWQOL-L Public Distress [ Time Frame: 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.

  18. IWQOL-L Work/Daily Activity [ Time Frame: 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.

  19. Body Weight (Absolute Change) [ Time Frame: Absolute (kg) Change from Baseline to Month 24 ]
    Body weight is measured in light indoor clothes.

  20. Diastolic Blood Pressure [ Time Frame: Change from Baseline to Month 24 ]
    Resting diastolic blood pressures is measured.

  21. High-density Lipoprotein Cholesterol [ Time Frame: Change from Baseline to Month 24 ]
    Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

  22. Low-density Lipoprotein Cholesterol [ Time Frame: Change from Baseline to Month 24 ]
    Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.

  23. Triglycerides [ Time Frame: Change from Baseline to Month 24 ]
    Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02561221


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Louisiana State University Health Sciences Center Shreveport
Tulane University
Ochsner Health System
Louisiana State University Health Sciences Center in New Orleans
Xavier University of Louisiana.
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Peter T Katzmarzyk, PhD Pennington Biomedical Research Center
  Study Documents (Full-Text)

Documents provided by Peter T. Katzmarzyk, Pennington Biomedical Research Center:
Publications of Results:
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Responsible Party: Peter T. Katzmarzyk, Associate Executive Director for Population and Public Health Sciences, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02561221    
Other Study ID Numbers: PBRC 2015-052
PCORI#OB-1402-10977 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI) )
First Posted: September 25, 2015    Key Record Dates
Results First Posted: December 10, 2020
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available upon reasonable request to the Principal Investigator 1 year after the publication of the Primary Outcomes manuscript.
Access Criteria: Access to the data must be approved by the PROPEL Publications Committee.
URL: https://www.nejm.org/doi/full/10.1056/NEJMoa2007448
Keywords provided by Peter T. Katzmarzyk, Pennington Biomedical Research Center:
primary care
pragmatic trial
weight loss
overweight
diet
physical activity
PCORI
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight Changes
Body Weight