Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB

Not Applicable

• Conditions: Obesity and Obesity-related Medical Conditions

• Registration Number: NCT06989281
• Lead Sponsor: University of Alabama at Birmingham

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).

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-03
• Study First Submitted: 2025-05-08
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Referral	Baseline	Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions.
Rate of Enrollment	Baseline	Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions.

Secondary Outcome Measures

Name	Time	Method
ITT Estimand, Change in Body Weight	Baseline and 12 months	A comparison body weight changes occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged.
ITT Estimand, Change in Composite Cardiometabolic Health	Baseline to Month 12	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.
Complier Average Causal Effect, Change in Body Weight	Baseline and 12 months	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.
Complier Average Causal Effect, Change in Composite Cardiometabolic Health	Baseline to Month 12	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States