Lifestyle Medicine for Obesity

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Not UAB patient

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a lifestyle medicine clinic in managing obesity and improving overall health. Participants will either receive extra encouragement to join the FLOW lifestyle medicine clinic or learn about it independently. The clinic emphasizes healthy lifestyle changes, which can benefit individuals with conditions like prediabetes, type 2 diabetes, high blood pressure, or unhealthy cholesterol levels. This trial suits current patients of the UAB Family & Community Medicine Clinic with a BMI of 25 or more and a diagnosis of one of these conditions. As an unphased trial, it provides a unique opportunity for patients to explore innovative lifestyle interventions that could enhance their health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FLOW Lifestyle Medicine Clinic is safe for patients?

Research has shown that lifestyle medicine clinics, such as the FLOW program, are generally safe for individuals. These clinics improve health by promoting changes in habits, like diet and exercise. Studies have found that participants usually experience positive changes with few negative effects.

One study found that a lifestyle clinic led by health professionals helped overweight and obese adults without causing serious side effects. Another study highlighted that significant lifestyle changes are safe and effective for managing obesity and related health risks.

Overall, lifestyle programs like FLOW are considered safe and recommended as a first step for treating obesity. They focus on healthy changes and are supported by evidence showing they are generally well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FLOW Lifestyle Medicine Clinic because it takes a personalized and proactive approach to tackling obesity. Unlike standard treatments that often rely on medication or surgery, FLOW emphasizes lifestyle changes tailored to each patient's needs, aiming to improve cardiometabolic health through sustainable habits. This method involves a more engaging patient-provider interaction, with healthcare providers encouraging involvement and offering direct support, which could lead to better long-term outcomes. By focusing on motivation and personal encouragement, FLOW has the potential to inspire lasting lifestyle changes, making it a promising alternative to more traditional obesity treatments.

What evidence suggests that the FLOW Lifestyle Medicine Clinic is effective for obesity?

Research has shown that lifestyle medicine clinics can effectively manage obesity. In one study, patients who attended a lifestyle clinic lost an average of 6.4 kg (14.1 lbs.), exceeding 5% of their total body weight. Another study found that 90.7% of participants reported successful weight loss after joining such a program. These clinics often employ health coaches and dietitians, which has been shown to reduce body mass index (BMI), a measure of body fat based on height and weight. Overall, lifestyle medicine clinics have shown promise in helping people with obesity achieve meaningful weight loss. Participants in this trial will be randomized into two groups: one group will receive extra encouragement to enroll in the FLOW lifestyle medicine clinic, while the other group will not receive this additional encouragement. ^{2 3 5 6 7}

Who Is on the Research Team?

Drew Sayer, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for individuals dealing with obesity who are interested in participating in a quality improvement project to evaluate the effectiveness of a lifestyle medicine clinic at UAB.

Inclusion Criteria

Current patient of the UAB Family & Community Medicine Clinic

BMI greater than or equal to 25 kg/m2

I have been diagnosed with prediabetes, type 2 diabetes, prehypertension, hypertension, or dyslipidemia.

Exclusion Criteria

Not a current patient of the UAB Family & Community Medicine Clinic

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants are encouraged or not encouraged to enroll in the FLOW lifestyle medicine clinic

12 months

Ongoing visits as part of primary care

Follow-up

Participants are monitored for changes in cardiometabolic health and body weight

12 months

What Are the Treatments Tested in This Trial?

Interventions

• FLOW Lifestyle Medicine Clinic

Trial Overview The FLOW Lifestyle Medicine Clinic's approach to managing obesity is being evaluated. Participants will be randomly assigned to experience this new clinic model as part of the project.

How Is the Trial Designed?

Group I: Encouraged to Enroll in FLOW Experimental Treatment 1 Intervention

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.

Group II: Not Encouraged to Enroll in FLOW Active Control 1 Intervention

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.")

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12178518/

A clustered randomized trial in Hail, Saudi Arabia - PMC This trial evaluated the effectiveness of a joint health coach and dietitian lifestyle clinic led by a family physician for overweight and obese adults.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7675107/

A longitudinal study to investigate the effects of a 12-week ... On average, patients lost 6.4 kg (14.1 lbs.), representing a percent total body weight loss of over 5%. Average BMI decrease was significant at 5.35±4.61%.

3. mdpi.com mdpi.com/2072-6643/17/14/2382

Lifestyle Medicine for Obesity in the Era of Highly Effective ... Studies have shown patients with modest preoperative weight loss have surgical advantages, such as a shortened surgery time and decreased postoperative ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/21642850.2023.2296461

Full article: Metrics for weight management success Results: 90.7% (39/43) of participants with an LS of 50 + reported successful weight loss, while just 5% (2/40) reported weight regain. 35.7% ( ...

5. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.051328

Effects of a 2-Year Primary Care Lifestyle Intervention on ... We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity.

6. patlynk.com patlynk.com/trial/NCT00454610

FLOW | Family Lifestyle Overweight Prevention Program The overall objective of this study is to compare the effectiveness of a behavioral, family-based weight management program and a self-help only group for the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3042942/

Evaluating clinic and community-based lifestyle ... A sample size of 200 participants (80 in CM, 80 in CM + CHW, and 40 in UC), is estimated to provide 82% power for detecting 3.5% difference in BMI between the ...