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Completed

NCT Number: NCT02561221

Promoting Successful Weight Loss in Primary Care in Louisiana

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.

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Key information

Conditions

Obesity Behavior Body Weight Body Weight Changes Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Counseling

Behavioral

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.

Primary outcomes

  1. Body Weight (Percent Change)

    Time frame: Percent (%) Change from Baseline to Month 24

    Body weight is measured in light indoor clothes.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

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

Registry information

Acronym: PROPEL

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2015
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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