ObesityPROPELNCT02561221
Promoting Successful Weight Loss in Primary Care in Louisiana
A study testing Lifestyle Counseling in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Lifestyle Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 803 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to 6 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Lifestyle Counseling
- Keywords
- primary care, pragmatic trial, weight loss, overweight, diet, physical activity, PCORI
- Medical subject headings
- Obesity, Weight Loss, Overweight, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Counseling | Experimental | 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. Receives: Behavioral: Lifestyle Counseling |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Body Weight (Percent Change)
Body weight is measured in light indoor clothes.
Measured: Percent (%) Change from Baseline to Month 24
Secondary outcomes (23)
Waist Circumference
Waist circumference is measured mid-way between the iliac crest and the lower rib margin.
Measured: Change from Baseline to Month 24
Systolic Blood Pressure
Resting systolic blood pressures is measured.
Measured: Change from Baseline to Month 24
Fasting Plasma Glucose
Glucose is measured in the fasted state with a point-of-care device.
Measured: Change from Baseline to Month 24
Total Cholesterol
Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline to Month 24
Body Weight (Absolute Change)
Body weight is measured in light indoor clothes.
Measured: Absolute (kg) Change from Baseline to Month 24
Diastolic Blood Pressure
Resting diastolic blood pressures is measured.
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.
Measured: 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.
Measured: Change from Baseline to Month 24
Triglycerides
Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Measured: Change from Baseline to Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startApr 2016
- Primary completion6 Sep 2019
- Study completion6 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Peter T. Katzmarzyk, Pennington Biomedical Research Center
- Investigators
- Peter T Katzmarzyk, PhD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561221
- Sponsor's protocol ID
- PBRC 2015-052
- Other IDs
- PCORI#OB-1402-10977
- Acronym
- PROPEL
- Status last verified
- Jul 2023
- First submitted
- 23 Sep 2015
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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
Publications
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 Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics. Contemp Clin Trials. 2018 Apr;67:1-10. doi: 10.1016/j.cct.2018.02.002. Epub 2018 Feb 8.
PubMed 29408562Myers 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.
PubMed 31248113Katzmarzyk 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 Cluster-Randomized Trial. N Engl J Med. 2020 Sep 3;383(10):909-918. doi: 10.1056/NEJMoa2007448.
PubMed 32877581Hochsmann 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 Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial. Circulation. 2021 Mar 23;143(12):1202-1214. doi: 10.1161/CIRCULATIONAHA.120.051328. Epub 2021 Feb 9.
PubMed 33557578Dorling 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 Louisiana (PROPEL) cluster-randomized trial. Am J Clin Nutr. 2022 Oct 6;116(4):1112-1122. doi: 10.1093/ajcn/nqac179.
PubMed 35762659Katzmarzyk 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 PROPEL trial. Int J Obes (Lond). 2022 Aug;46(8):1456-1462. doi: 10.1038/s41366-022-01129-9. Epub 2022 May 6.
PubMed 35523955Katzmarzyk 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. Clin Obes. 2022 Aug;12(4):e12524. doi: 10.1111/cob.12524. Epub 2022 Apr 12.
PubMed 35412010Katzmarzyk 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. doi: 10.1002/oby.23292. Epub 2021 Oct 29.
PubMed 34714976Katzmarzyk 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 2023 Jan 26.
PubMed 36702913Denstel KD, Mire EF, Martin CK, Apolzan JW, Arnold CL, Davis TC, Lavie CJ, Newton RL Jr, Zhang D, Price-Haywood EG, Katzmarzyk PT; PROPEL Research Group. Effects of a 2-Year Primary Care Weight Loss Intervention on Quality of Life in Patients With Obesity. Obesity (Silver Spring). 2026 May;34(5):1032-1044. doi: 10.1002/oby.70189. Epub 2026 Apr 4.
PubMed 41934285Katzmarzyk PT, Mire EF, Horswell R, Chu ST, Zhang D, Martin CK, Newton RL, Apolzan JW, Price-Haywood EG, Fort D, Carton TW, Denstel KD; PROPEL Research Group. Four-year follow-up of weight loss maintenance using electronic medical record data: The PROPEL trial. Obes Sci Pract. 2024 Oct 19;10(5):e70017. doi: 10.1002/osp4.70017. eCollection 2024 Oct.
PubMed 39429541Hochsmann C, Martin CK, Apolzan JW, Dorling JL, Newton RL Jr, Denstel KD, Mire EF, Johnson WD, Zhang D, Arnold CL, Davis TC, Fonseca V, Thethi TK, Lavie CJ, Springgate B, Katzmarzyk PT; PROPEL Research Group. Initial weight loss and early intervention adherence predict long-term weight loss during the Promoting Successful Weight Loss in Primary Care in Louisiana lifestyle intervention. Obesity (Silver Spring). 2023 Sep;31(9):2272-2282. doi: 10.1002/oby.23854. Epub 2023 Aug 8.
PubMed 37551762Apolzan JW, Martin CK, Newton RL Jr, Myers CA, Arnold CL, Davis TC, Johnson WD, Zhang D, Hochsmann C, Fonseca VA, Denstel KD, Mire EF, Springgate BF, Lavie CJ, Katzmarzyk PT; PROPEL Research Group. Dietary intake during a pragmatic cluster-randomized weight loss trial in an underserved population in primary care. Nutr J. 2023 Aug 2;22(1):38. doi: 10.1186/s12937-023-00864-7.
PubMed 37528391
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Successful Weight Loss in Primary Care in Louisiana
- ClinicalTrials.gov ID
- NCT02561221
- Acronym / sponsor ID
- PROPEL / PBRC 2015-052
- Conditions
- Obesity
- Keywords
- primary care, pragmatic trial, weight loss, overweight, diet, physical activity, PCORI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- 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
- Study start
- Apr 2016
- Primary completion
- 6 Sep 2019 (actual)
- Study completion
- 6 Sep 2019 (actual)
- First posted
- 25 Sep 2015 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Counseling | Experimental | Behavioral: Lifestyle CounselingPatients 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle CounselingTrained 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. | Behavioural | Lifestyle Counseling |
Primary outcome
Body Weight (Percent Change)
Time frame: Percent (%) Change from Baseline to Month 24
Body weight is measured in light indoor clothes.
23 secondary outcomes
Waist Circumference
Time frame: Change from Baseline to Month 24
Systolic Blood Pressure
Time frame: Change from Baseline to Month 24
Fasting Plasma Glucose
Time frame: Change from Baseline to Month 24
Total Cholesterol
Time frame: Change from Baseline to Month 24
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function
Time frame: Change from Baseline to Month 24
PROMIS-29 Anxiety
Time frame: Change from Baseline to Month 24
PROMIS-29 Depression
Time frame: Change from Baseline to Month 24
PROMIS-29 Fatigue
Time frame: Change from Baseline to Month 24
PROMIS-29 Sleep Disturbance
Time frame: Change from Baseline to Month 24
PROMIS-29 Social Functioning
Time frame: Change from Baseline to Month 24
PROMIS-29 Pain Interference
Time frame: Change from Baseline to Month 24
PROMIS-29 Pain Intensity
Time frame: 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
IWQOL-L Physical Function
Time frame: Change from Baseline to Month 24
IWQOL-L Self Esteem
Time frame: Change from Baseline to Month 24
IWQOL-L Sexual Life
Time frame: Change from Baseline to Month 24
IWQOL-L Public Distress
Time frame: Change from Baseline to Month 24
IWQOL-L Work/Daily Activity
Time frame: Change from Baseline to Month 24
Body Weight (Absolute Change)
Time frame: Absolute (kg) Change from Baseline to Month 24
Diastolic Blood Pressure
Time frame: Change from Baseline to Month 24
High-density Lipoprotein Cholesterol
Time frame: Change from Baseline to Month 24
Low-density Lipoprotein Cholesterol
Time frame: Change from Baseline to Month 24
Triglycerides
Time frame: Change from Baseline to Month 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29408562Katzmarzyk 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 Primary Care in Louisiana (PROPEL): Rationale, design and baseline characteristics. Contemp Clin Trials. 2018 Apr;67:1-10. doi: 10.1016/j.cct.2018.02.002. Epub 2018 Feb 8.
- Results publication: PubMed 31248113Myers 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.
- Results publication: PubMed 32877581Katzmarzyk 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 Cluster-Randomized Trial. N Engl J Med. 2020 Sep 3;383(10):909-918. doi: 10.1056/NEJMoa2007448.
- Results publication: PubMed 33557578Hochsmann 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 Intervention on Cardiometabolic Risk Factors: A Cluster-Randomized Trial. Circulation. 2021 Mar 23;143(12):1202-1214. doi: 10.1161/CIRCULATIONAHA.120.051328. Epub 2021 Feb 9.
- Results publication: PubMed 35762659Dorling 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 Louisiana (PROPEL) cluster-randomized trial. Am J Clin Nutr. 2022 Oct 6;116(4):1112-1122. doi: 10.1093/ajcn/nqac179.
- Results publication: PubMed 35523955Katzmarzyk 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 PROPEL trial. Int J Obes (Lond). 2022 Aug;46(8):1456-1462. doi: 10.1038/s41366-022-01129-9. Epub 2022 May 6.
- Results publication: PubMed 35412010Katzmarzyk 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. Clin Obes. 2022 Aug;12(4):e12524. doi: 10.1111/cob.12524. Epub 2022 Apr 12.
- Results publication: PubMed 34714976Katzmarzyk 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. doi: 10.1002/oby.23292. Epub 2021 Oct 29.
- Results publication: PubMed 36702913Katzmarzyk 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 2023 Jan 26.
- Derived from this study: PubMed 41934285Denstel KD, Mire EF, Martin CK, Apolzan JW, Arnold CL, Davis TC, Lavie CJ, Newton RL Jr, Zhang D, Price-Haywood EG, Katzmarzyk PT; PROPEL Research Group. Effects of a 2-Year Primary Care Weight Loss Intervention on Quality of Life in Patients With Obesity. Obesity (Silver Spring). 2026 May;34(5):1032-1044. doi: 10.1002/oby.70189. Epub 2026 Apr 4.
- Derived from this study: PubMed 39429541Katzmarzyk PT, Mire EF, Horswell R, Chu ST, Zhang D, Martin CK, Newton RL, Apolzan JW, Price-Haywood EG, Fort D, Carton TW, Denstel KD; PROPEL Research Group. Four-year follow-up of weight loss maintenance using electronic medical record data: The PROPEL trial. Obes Sci Pract. 2024 Oct 19;10(5):e70017. doi: 10.1002/osp4.70017. eCollection 2024 Oct.
- Derived from this study: PubMed 37551762Hochsmann C, Martin CK, Apolzan JW, Dorling JL, Newton RL Jr, Denstel KD, Mire EF, Johnson WD, Zhang D, Arnold CL, Davis TC, Fonseca V, Thethi TK, Lavie CJ, Springgate B, Katzmarzyk PT; PROPEL Research Group. Initial weight loss and early intervention adherence predict long-term weight loss during the Promoting Successful Weight Loss in Primary Care in Louisiana lifestyle intervention. Obesity (Silver Spring). 2023 Sep;31(9):2272-2282. doi: 10.1002/oby.23854. Epub 2023 Aug 8.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter T Katzmarzyk, PhD principal investigator
Pennington Biomedical Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Counseling in people with Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (Percent Change) (time frame: Percent (%) Change from Baseline to Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02561221, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.