Clinical trial NCT06989281: Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB
Official title: Randomized Encouragement Trial to Evaluate the Implementation and Effectiveness of a Lifestyle Medicine Clinic in Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obesity and Obesity-related Medical Conditions
Keywords: Quality Improvement Project
Implementation
Clinical Effectiveness
Encouragement Design
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: Rate of Referral
timeFrame: Baseline
measure: Rate of Enrollment
timeFrame: Baseline
Secondary outcomes:
measure: ITT Estimand, Change in Body Weight
timeFrame: Baseline and 12 months
measure: ITT Estimand, Change in Composite Cardiometabolic Health
timeFrame: Baseline to Month 12
measure: Complier Average Causal Effect, Change in Body Weight
timeFrame: Baseline and 12 months
measure: Complier Average Causal Effect, Change in Composite Cardiometabolic Health
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Drew Sayer, PhD
role: PRINCIPAL_INVESTIGATOR
References: