Obesity and Obesity-related Medical Conditions
Conditions
Keywords
Quality Improvement Project, Implementation, Clinical Effectiveness, Encouragement Design
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).
Interventions
BEHAVIORALFLOW 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.
Sponsors
University of Alabama at Birmingham
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDrew Sayer, PhD
University of Alabama at Birmingham
Outcome results
None listed