Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FLOW Lifestyle Medicine Clinic.
- Who it may be relevant to
- Registry conditions: Obesity and Obesity-related Medical Conditions. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Encouragement Trial to Evaluate the Implementation and Effectiveness of a Lifestyle Medicine Clinic in Primary Care
Overview
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).
Interventions
- 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
Primary outcome measures
- Rate of Referral [Time frame: Baseline]
- Rate of Enrollment [Time frame: Baseline]
Secondary outcome measures (4)
- ITT Estimand, Change in Body Weight [Time frame: Baseline and 12 months]
- ITT Estimand, Change in Composite Cardiometabolic Health [Time frame: Baseline to Month 12]
- Complier Average Causal Effect, Change in Body Weight [Time frame: Baseline and 12 months]
- Complier Average Causal Effect, Change in Composite Cardiometabolic Health [Time frame: Baseline to Month 12]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Not a current patient of the UAB Family \& Community Medicine Clinic or UAB Rheumatology Clinic
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT06989281 · IRB-300013918 · A-40195