Apply to Trial

Compensation: Varies

Number of Visits: 4

Duration: 12 months

1000 Participants Needed

Group vs Individual Obesity Care for Obesity

Overseen ByPetra Duran, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Charles Drew University of Medicine and Science

Must not be taking: Weight loss drugs

Disqualifiers: Mental illness, Substance abuse, Bariatric surgery, others

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

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking weight loss medications and supplements advertised for weight loss before enrolling. Other medications, like those for blood pressure or diabetes, can be adjusted by your primary care provider if needed.

What data supports the effectiveness of the treatment involving Dietitian Individual Visit and Medical Group Visit for obesity care?

Research suggests that involving dietitians in obesity care as part of a healthcare team can lead to more effective management of obesity. Dietitians are well-suited to deliver lifestyle interventions, which are key in treating obesity, and their regular involvement can improve clinical monitoring and support for patients.¹ ² ³ ⁴ ⁵

Is the Group vs Individual Obesity Care treatment safe for humans?

The research does not provide specific safety data for the Group vs Individual Obesity Care treatment, but dietitian-led interventions, which are part of this approach, are generally considered safe for managing obesity.¹ ² ³ ⁴ ⁶

How does the Group vs Individual Obesity Care treatment differ from other obesity treatments?

This treatment is unique because it combines individual visits with a dietitian and group medical visits, allowing for personalized dietary guidance and shared medical appointments. This approach leverages the benefits of both one-on-one and group support, aiming to provide comprehensive care by addressing nutrition, physical activity, and other lifestyle factors in a coordinated manner.² ³ ⁷ ⁸ ⁹

What is the purpose of this trial?

The purpose of this study has two aims: Aim 1: To compare a medical group visit model versus a dietitian-let model (shared composite group visit approach vs individualized dietitian-led approach) to provide obesity care in a real-world diverse inner city population.Aim 2. To use both perivascular fat attenuation and coronary artery calcium (CAC) scores in those receiving composite group intervention vs. dietitian-led intervention to see if lifestyle intervention can reduce plaque progression and improve perivascular fat attenuation.

Research Team

Theodore Friedman, MD. PhD

Principal Investigator

Charles Drew University of Medicine and Science

Eligibility Criteria

This trial is for adults with obesity (BMI ≥ 30 kg/m2) from any ethnic background, interested in weight loss and willing to try a group medical visit or individual dietitian-led care. They must not be on certain weight loss medications or supplements recently, nor participating in other obesity treatments. Women over 50 and men over 40 may also get a heart scan.

Inclusion Criteria

BMI ≥ 30 kg/m2

I identify as male, female, or LGBT.

I can receive care at LAC-DHS and have a PCP who can adjust my medications.

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Exclusion Criteria

Currently participating in another obesity treatment program

I am currently taking medication for weight loss.

I had weight loss surgery less than a year ago.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Baseline Assessment

Participants are randomized into either the composite group visit or dietitian-led visit and undergo baseline assessments

1 week

1 visit (in-person)

Treatment

Participants receive obesity management in either a group setting led by an endocrinologist and nutritionist or in an individual setting led by a registered dietitian

12 months

Monthly visits (in-person)

Sub-study (Optional)

A subset of participants undergo Coronary Artery Calcium (CAC) scanning and perivascular fat measurements

12 months

2 visits (in-person) for CAC scanning

Follow-up

Participants are monitored for changes in health outcomes such as HbA1c, diet quality, physical activity, and psychological distress

4 weeks

1 visit (in-person)

Treatment Details

Interventions

Dietitian Individual Visit
Medical Group Visit

Trial Overview The study compares two ways of managing obesity: one through group medical visits and the other via one-on-one sessions with a dietitian. It will check if these interventions can reduce heart-related fat and slow down plaque buildup in arteries.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Medical Group VisitExperimental Treatment1 Intervention

Participants receive obesity management in a group setting let by endocrinologist and nutritionist.

Group II: Dietitian-Led VisitExperimental Treatment1 Intervention

Participant receives obesity management in an individual setting lead by registered dietitian.