Promoting Successful Weight Loss in Primary Care in Louisiana

Not Applicable

Completed

Conditions: Obesity

Interventions: Behavioral: Lifestyle Counseling

Registration Number: NCT02561221

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 803

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Counseling	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Total Cholesterol	Change from Baseline to Month 24	Blood lipids/cholesterol are measured in the fasted state with a point-of-care device.
Systolic Blood Pressure	Change from Baseline to Month 24	Resting systolic blood pressures is measured.
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.
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.
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.
Diastolic Blood Pressure	Change from Baseline to Month 24	Resting diastolic 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.
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 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.
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 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.
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.
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.
Body Weight (Absolute Change)	Absolute (kg) Change from Baseline to Month 24	Body weight is measured in light indoor clothes.
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.
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 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.
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.
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.