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| ID | Type | Description | Link |
|---|---|---|---|
| A-40195 | Other Grant/Funding Number | Eli Lilly |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This is a randomized quality improvement project (i.e., not a research study) that will test the implementation and effectiveness of a lifestyle medicine clinic at the University of Alabama at Birmingham.
This is a randomized quality improvement project that has received a non-human subjects research determination from the IRB at the University of Alabama at Birmingham. This study will use a randomized encouragement trial design to test whether a lifestyle medicine clinic at UAB (FLOW: Fitness, Lifestyle, and Optimum Wellness) is implementable and effective for improving cardiometabolic health (e.g., body weight, body composition, blood pressure, blood glucose, and blood lipids). Only patients of the UAB Family and Community Clinic are included in this project (i.e., no outside recruitment/enrollment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Encouraged to Enroll in FLOW | Experimental | Patients randomized to this condition receive extra encouragement to consider enrolling in the FLOW lifestyle medicine clinic. This encouragement includes the addition of 2 questions added to their patients' pre-visit intake process regarding their interest in making healthy lifestyle changes to improve their cardiometabolic health. If affirmative, the Certified Medical Assistant will provide the patient with a FLOW brochure and make a note for the provider to follow-up with the patient and consider referral to the FLOW clinic. |
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| Not Encouraged to Enroll in FLOW | Active Comparator | Patients randomized to this condition do not receive extra encouragement to enroll in the FLOW lifestyle medicine clinic. They are still able to access to the FLOW clinic via brochures placed in the waiting area and exam rooms or direct referral by their healthcare provider (without having been "encouraged.") |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLOW Lifestyle Medicine Clinic | Behavioral | The FLOW Lifestyle Medicine Clinic is a 12-month multidisciplinary program for improving obesity and obesity-related chronic conditions. FLOW is an evidence-based program that aligns with USPSTF recommendations for intensive behavioral counseling for obesity and cardiovascular disease risk reduction. There are at least 12 clinician/patient encounters in the FLOW clinic over 12 months including 6 with a registered dietitian and 6 with a FLOW physician. Behavioral Health assessments and visits are also offered as part of FLOW but are optional. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Referral | Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions. | Baseline |
| Rate of Enrollment | Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| ITT Estimand, Change in Body Weight | A comparison body weight changes occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged. | Baseline and 12 months |
| ITT Estimand, Change in Composite Cardiometabolic Health |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Drew Sayer, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
This project is a quality improvement project intended for improving obesity and obesity related cardiometabolic health among UAB patients. Because this project is not "research" (i.e., contributing to generalizable knowledge), we do not believe it is appropriate to share IDP with outside investigators.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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This QI project uses a randomized encouragement trial design. All patients of the UAB Family and Community Medicine Clinic will have access to the FLOW lifestyle medicine clinic via program brochures placed in the clinic and/or direct referral from their healthcare providers. Some patients (i.e., Encouraged condition) will be randomly assigned to receive extra encouragement to consider enrolling in the FLOW lifestyle medicine clinic. Because all patients have access to the clinic, the intervention is minimal risk, and the findings are specific to the UAB Medicine Health System, this project is being conducted without obtaining patient consent (non-human subjects research).
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A comparison of changes in cardiometabolic health occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged. The composite score is derived from values for body weight, percentage body fat, blood pressure, clinical labs, fitness tests, and questionnaires.
| Baseline to Month 12 |
| Complier Average Causal Effect, Change in Body Weight | A comparison body weight changes occurring over 12 months between patients who enrolled vs. did not enroll in FLOW regardless of whether they were assigned to Encouraged or Not Encouraged. | Baseline and 12 months |
| Complier Average Causal Effect, Change in Composite Cardiometabolic Health | A comparison changes in cardiometabolic health occurring over 12 months between patients who enrolled vs. did not enroll in FLOW regardless of whether they were assigned to Encouraged or Not Encouraged. The composite score is derived from values for body weight, percentage body fat, blood pressure, clinical labs, fitness tests, and questionnaires. | Baseline to Month 12 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |