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

July 21, 2023 updated by: Peter T. Katzmarzyk, Pennington Biomedical Research Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

803

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

Patient-Centered Outcomes Research Institute
Tulane University
Louisiana State University Health Sciences Center in New Orleans
Ochsner Health System
Louisiana State University Health Sciences Center Shreveport
Xavier University of Louisiana.

Investigators

  • Principal Investigator: Peter T Katzmarzyk, PhD, Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

September 6, 2019

Study Completion (Actual)

September 6, 2019

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimated)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2015-052
  • PCORI#OB-1402-10977 (Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Time Frame

Data will be made available upon reasonable request to the Principal Investigator 1 year after the publication of the Primary Outcomes manuscript.

IPD Sharing Access Criteria

Access to the data must be approved by the PROPEL Publications Committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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