Promoting Successful Weight Loss in Primary Care in Louisiana

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02561221

Acronym

PROPEL

Enrollment

803

Registered

2015-09-25

Start date

2016-04-30

Completion date

2019-09-06

Last updated

2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

primary care, pragmatic trial, weight loss, overweight, diet, physical activity, PCORI

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.

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.

Interventions

BEHAVIORALLifestyle 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Body Weight (Percent Change)	Percent (%) Change from Baseline to Month 24	Body weight is measured in light indoor clothes.

Secondary

Measure	Time frame	Description
Systolic Blood Pressure	Change from Baseline to Month 24	Resting systolic blood pressures is measured.
Fasting Plasma Glucose	Change from Baseline to Month 24	Glucose is measured in the fasted state with a point-of-care device.
Total Cholesterol	Change from Baseline to Month 24	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function	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.
PROMIS-29 Anxiety	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.
PROMIS-29 Depression	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.
PROMIS-29 Fatigue	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.
PROMIS-29 Sleep Disturbance	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.
PROMIS-29 Social Functioning	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.
PROMIS-29 Pain Interference	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.
PROMIS-29 Pain Intensity	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.
Waist Circumference	Change from Baseline to Month 24	Waist circumference is measured mid-way between the iliac crest and the lower rib margin.
IWQOL-L Physical Function	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.
IWQOL-L Self Esteem	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.
IWQOL-L Sexual Life	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.
IWQOL-L Public Distress	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.
IWQOL-L Work/Daily Activity	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.
Body Weight (Absolute Change)	Absolute (kg) Change from Baseline to Month 24	Body weight is measured in light indoor clothes.
Diastolic Blood Pressure	Change from Baseline to Month 24	Resting diastolic blood pressures is measured.
High-density Lipoprotein Cholesterol	Change from Baseline to Month 24	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Low-density Lipoprotein Cholesterol	Change from Baseline to Month 24	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Triglycerides	Change from Baseline to Month 24	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score	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.

Countries

United States

Participant flow

Recruitment details

Eighteen primary care clinics were randomized equally to either the Intensive Lifestyle Intervention or Usual Care. Patients received the intervention to which their clinic was assigned. Study enrollment occurred from April 2016 to September 2017. Patients completed a pre-screener and attended a screening visit which included the consent process and measurement to determine height and weight for BMI among other eligibility criteria. Patients were enrolled upon baseline visit completion.

Participants by arm

Arm	Count
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. 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.	452
Usual Care Patients assigned to the usual care arm continued to interact with their Primary Care Practitioners according to their usual health care 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.	351
Total	803

Baseline characteristics

Characteristic	Lifestyle Counseling	Usual Care	Total
Age, Continuous	48.8 years STANDARD_DEVIATION 12.7	50.1 years STANDARD_DEVIATION 13.6	49.4 years STANDARD_DEVIATION 13.1
Body Mass Index	37.3 kg/m^2 STANDARD_DEVIATION 4.6	37.2 kg/m^2 STANDARD_DEVIATION 4.8	37.2 kg/m^2 STANDARD_DEVIATION 4.7
Race/Ethnicity, Customized African American	332 Participants	208 Participants	540 Participants
Race/Ethnicity, Customized Other	25 Participants	30 Participants	55 Participants
Race/Ethnicity, Customized White	95 Participants	113 Participants	208 Participants
Sex: Female, Male Female	398 Participants	280 Participants	678 Participants
Sex: Female, Male Male	54 Participants	71 Participants	125 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 452	1 / 351
other Total, other adverse events	35 / 452	46 / 351
serious Total, serious adverse events	48 / 452	35 / 351

Outcome results

Primary

Body Weight (Percent Change)

Body weight is measured in light indoor clothes.

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

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Lifestyle Counseling	Body Weight (Percent Change)	-4.99 percent change
Usual Care	Body Weight (Percent Change)	-0.48 percent change

Secondary

Body Weight (Absolute Change)

Body weight is measured in light indoor clothes.

Time frame: Absolute (kg) Change from Baseline to Month 24

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Lifestyle Counseling	Body Weight (Absolute Change)	-5.43 kg
Usual Care	Body Weight (Absolute Change)	-0.91 kg

Secondary