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Enrolling by Invitation

NCT Number: NCT06989281

Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB

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.

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FLOW Lifestyle Medicine Clinic

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.

Primary outcomes

  1. Rate of Referral

    Time frame: Baseline

    Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions.

  2. Rate of Enrollment

    Time frame: Baseline

    Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions.

Secondary outcomes

  1. ITT Estimand, Change in Body Weight

    Time frame: Baseline and 12 months

    A comparison body weight changes occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged.

  2. ITT Estimand, Change in Composite Cardiometabolic Health

    Time frame: 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.

  3. Complier Average Causal Effect, Change in Body Weight

    Time frame: 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.

  4. Complier Average Causal Effect, Change in Composite Cardiometabolic Health

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

Randomized Encouragement Trial to Evaluate the Implementation and Effectiveness of a Lifestyle Medicine Clinic in Primary Care

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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