Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB

NCT06989281 | Enrolling By Invitation

• 2 other identifiers: IRB-300013918A-40195
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

Quality Improvement Project; Implementation; Clinical Effectiveness; Encouragement Design

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• ITT Estimand, Change in Body Weight

  Baseline and 12 months

• ITT Estimand, Change in Composite Cardiometabolic Health

  Baseline to Month 12

• Complier Average Causal Effect, Change in Body Weight

  Baseline and 12 months

• Complier Average Causal Effect, Change in Composite Cardiometabolic Health

  Baseline to Month 12

Study Arms (2)

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.

Behavioral: FLOW Lifestyle Medicine Clinic

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.")

Behavioral: FLOW Lifestyle Medicine Clinic

Interventions

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.

Encouraged to Enroll in FLOW; Not Encouraged to Enroll in FLOW

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Current patient of the UAB Family \& Community Medicine Clinic or UAB Rheumatology Clinic
• BMI: greater than or equal to 25 kg/m2
• Previous diagnosis of at least one of the following conditions:
• prediabetes or type 2 diabetes
• prehypertension or hypertension
• dyslipidemia
• psoriatic arthritis

You may not qualify if:

• Not a current patient of the UAB Family \& Community Medicine Clinic or UAB Rheumatology Clinic

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Drew Sayer, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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).

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: May 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)