Obesity and Obesity-related Medical ConditionsNCT06989281
Evaluation of a Primary Care Based Lifestyle Medicine Clinic at UAB
A study testing FLOW Lifestyle Medicine Clinic in people with Obesity and Obesity-related Medical Conditions, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- FLOW Lifestyle Medicine Clinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a current patient of the UAB Family \& Community Medicine Clinic or UAB Rheumatology Clinic
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Randomized Encouragement Trial to Evaluate the Implementation and Effectiveness of a Lifestyle Medicine Clinic in Primary Care
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.
Read the 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).
- Being tested
- FLOW Lifestyle Medicine Clinic
- Keywords
- Quality Improvement Project, Implementation, Clinical Effectiveness, Encouragement Design
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOW Lifestyle Medicine ClinicBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Encouraged to Enroll in FLOW | Experimental | Patients randomized to this condition receive extra encouragement to consider enrolling in the FLOW lifestyle medicine clinic. This encouragement includes the addition of 2 questions added to their patients' pre-visit intake process regarding their interest in making healthy lifestyle changes to improve their cardiometabolic health. If affirmative, the Certified Medical Assistant will provide the patient with a FLOW brochure and make a note for the provider to follow-up with the patient and consider referral to the FLOW clinic. Receives: Behavioral: FLOW Lifestyle Medicine Clinic |
| Not Encouraged to Enroll in FLOW | Active comparator | Patients randomized to this condition do not receive extra encouragement to enroll in the FLOW lifestyle medicine clinic. They are still able to access to the FLOW clinic via brochures placed in the waiting area and exam rooms or direct referral by their healthcare provider (without having been "encouraged.") Receives: Behavioral: FLOW Lifestyle Medicine Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Referral
Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions.
Measured: Baseline
Rate of Enrollment
Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions.
Measured: Baseline
Secondary outcomes (4)
ITT Estimand, Change in Body Weight
A comparison body weight changes occurring over 12 months between patients assigned to Encouraged vs. Not Encouraged.
Measured: Baseline and 12 months
ITT Estimand, Change in Composite Cardiometabolic Health
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.
Measured: Baseline to Month 12
Complier Average Causal Effect, Change in Body Weight
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.
Measured: Baseline and 12 months
Complier Average Causal Effect, Change in Composite Cardiometabolic Health
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.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start3 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Drew Sayer, University of Alabama at Birmingham
- Investigators
- Drew Sayer, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989281
- Sponsor's protocol ID
- IRB-300013918
- Other IDs
- A-40195
- Status last verified
- May 2026
- First submitted
- 8 May 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This project is a quality improvement project intended for improving obesity and obesity related cardiometabolic health among UAB patients. Because this project is not "research" (i.e., contributing to generalizable knowledge), we do not believe it is appropriate to share IDP with outside investigators.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Encouragement Trial to Evaluate the Implementation and Effectiveness of a Lifestyle Medicine Clinic in Primary Care
- ClinicalTrials.gov ID
- NCT06989281
- Acronym / sponsor ID
- IRB-300013918
- Keywords
- Quality Improvement Project, Implementation, Clinical Effectiveness, Encouragement Design
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 3 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Encouraged to Enroll in FLOW | Experimental | Behavioral: FLOW Lifestyle Medicine ClinicPatients randomized to this condition receive extra encouragement to consider enrolling in the FLOW lifestyle medicine clinic. This encouragement includes the addition of 2 questions added to their patients' pre-visit intake process regarding their interest in making healthy lifestyle changes to improve their cardiometabolic health. If affirmative, the Certified Medical Assistant will provide the patient with a FLOW brochure and make a note for the provider to follow-up with the patient and consider referral to the FLOW clinic. |
| Not Encouraged to Enroll in FLOW | Active comparator | Behavioral: FLOW Lifestyle Medicine ClinicPatients randomized to this condition do not receive extra encouragement to enroll in the FLOW lifestyle medicine clinic. They are still able to access to the FLOW clinic via brochures placed in the waiting area and exam rooms or direct referral by their healthcare provider (without having been "encouraged.") |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Not a current patient of the UAB Family \& Community Medicine Clinic or UAB Rheumatology Clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FLOW Lifestyle Medicine ClinicThe 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. | Behavioural | Encouraged to Enroll in FLOW, Not Encouraged to Enroll in FLOW |
Primary outcome
Rate of Referral
Time frame: Baseline
Comparison of rates of referral to the FLOW clinic between the Encouraged and Not Encouraged conditions.
Rate of Enrollment
Time frame: Baseline
Comparison of rates of enrollment in the FLOW clinic between the Encouraged and Not Encouraged conditions.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. This project is a quality improvement project intended for improving obesity and obesity related cardiometabolic health among UAB patients. Because this project is not "research" (i.e., contributing to generalizable knowledge), we do not believe it is appropriate to share IDP with outside investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Drew Sayer, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLOW Lifestyle Medicine Clinic in people with Obesity and Obesity-related Medical Conditions, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Referral (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.