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Group vs Individual Obesity Care for Obesity

N/A

Waitlist Available

Led By Theodore Friedman, MD. PhD

Research Sponsored by Charles Drew University of Medicine and Science

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Be older than 18 years old

Must not have

Currently on metformin or topiramate primarily prescribed for weight loss

Currently on a weight loss medication (orlistat, lorcaserin, and phentermine/topiramate-ER, phenetermine, diethylpropion, phendimetrazine and benzphetamine)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, months 3, 6 and 12.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two ways of providing obesity care, either through a group visit or an individualized dietitian-led approach, in order to see which is more effective in a real-world diverse inner city population. Additionally, this trial will use two measures, perivascular fat attenuation and coronary artery calcium scores, to see if lifestyle intervention can reduce plaque progression and improve perivascular fat attenuation.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on lifestyle interventions like dietary changes rather than medication, side effects are minimal but could include potential discomfort from new eating habits or stress from group settings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking metformin or topiramate for weight loss.

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I am currently taking medication for weight loss.

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I had weight loss surgery less than a year ago.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, months 3, 6 and 12.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, months 3, 6 and 12.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, months 3, 6 and 12. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in General Health Questionnaire (GHQ-12) Score

Body Weight Changes

Change in Healthy Eating Index-2015 Score

+3 more

Secondary study objectives

Change in Coronary Artery Calcification (CAC) score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Charles Drew University of Medicine and ScienceLead Sponsor

53 Previous Clinical Trials

7,743 Total Patients Enrolled

3 Trials studying Obesity

93 Patients Enrolled for Obesity

Theodore Friedman, MD. PhD4.122 ReviewsPrincipal Investigator - Charles Drew University of Medicine and Science

Charles Drew University of Medicine and Science

1Patient Review

I was extremely disappointed with my experience. Dr Friedman seemed more concerned with money than with providing care, and was very cold and unempathetic. He also prescribed me expensive medication without first running tests, and then contradicted himself multiple times. I would not recommend him to anyone.