N/A
N=803
Promoting Successful Weight Loss in Primary Care in Louisiana
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02561221 ↗Enrolled (actual)
803
Serious AEs
10.3%
Results posted
Dec 2020
Primary outcome: Primary: Body Weight (Percent Change) — -4.99; -0.48 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle Counseling (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Body Weight (Percent Change) |
-4.99; -0.48 | — |
| SECONDARY Waist Circumference |
-4.42; 0.71 | — |
| SECONDARY Systolic Blood Pressure |
1.94; 0.41 | — |
| SECONDARY Fasting Plasma Glucose |
-1.25; -0.33 | — |
| SECONDARY Total Cholesterol |
4.64; -1.26 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS-29) Physical Function |
0.82; -0.39 | — |
| SECONDARY PROMIS-29 Anxiety |
-0.92; -0.53 | — |
| SECONDARY PROMIS-29 Depression |
-0.18; 0.64 | — |
| SECONDARY PROMIS-29 Fatigue |
-2.82; -1.03 | — |
| SECONDARY PROMIS-29 Sleep Disturbance |
-1.25; -0.35 | — |
| SECONDARY PROMIS-29 Social Functioning |
1.57; 0.15 | — |
| SECONDARY PROMIS-29 Pain Interference |
-1.06; 0.21 | — |
| SECONDARY PROMIS-29 Pain Intensity |
-0.02; 0.21 | — |
| SECONDARY Impact of Weight on Quality of Life-Lite (IWQOL-L) Total Score |
11.02; 4.36 | — |
| SECONDARY IWQOL-L Physical Function |
12.31; 4.11 | — |
| SECONDARY IWQOL-L Self Esteem |
14.39; 7.62 | — |
| SECONDARY IWQOL-L Sexual Life |
14.32; 4.49 | — |
| SECONDARY IWQOL-L Public Distress |
5.38; 2.41 | — |
| SECONDARY IWQOL-L Work/Daily Activity |
5.48; 1.47 | — |
| SECONDARY Body Weight (Absolute Change) |
-5.43; -0.91 | — |
| SECONDARY Diastolic Blood Pressure |
-0.61; -0.64 | — |
| SECONDARY High-density Lipoprotein Cholesterol |
4.16; -0.44 | — |
| SECONDARY Low-density Lipoprotein Cholesterol |
3.22; -0.17 | — |
| SECONDARY Triglycerides |
-11.23; -5.58 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02561221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.