An interventional study of FLOW Lifestyle Medicine Clinic in Obesity and Obesity-related Medical Conditions, sponsored by University of Alabama at Birmingham. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
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).
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: FLOW Lifestyle Medicine Clinic
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.")
Behavioral: FLOW Lifestyle Medicine Clinic
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.
Rate of Referral
Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions.
Time frame: Baseline
Rate of Enrollment
Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions.
Time frame: Baseline
ITT Estimand, Change in Body Weight
A comparison body weight changes occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged.
Time frame: Baseline and 12 months
ITT Estimand, Change in Composite Cardiometabolic Health
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Month 12
Plan to share: No — 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.
No publications or documents are linked to this record.
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University of Alabama at Birmingham