Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB

NCT ID: NCT06989281

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-03
• Study Completion Date: 2026-12-31

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.

Detailed Description

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).

Conditions

Obesity and Obesity-related Medical Conditions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Encouraged to Enroll in FLOW

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.

Group Type: EXPERIMENTAL

FLOW Lifestyle Medicine Clinic

Intervention Type: 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.

Not Encouraged to Enroll in FLOW

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.")

Group Type: ACTIVE_COMPARATOR

FLOW Lifestyle Medicine Clinic

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Current patient of the UAB Family & Community Medicine 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Drew Sayer

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Drew Sayer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

IRB-300013918

Identifier Type: -

Identifier Source: org_study_id