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NCT04725058Active, not recruiting

Obesity Group Visits. A Novel Way to Approach the Obesity Epidemic in an Inner-City Setting

Source: ClinicalTrials.gov · Last updated 15 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
11 Jan 2021
Start date
3 Feb 2020
Primary completion date
28 Dec 2025
Lead sponsor
Charles Drew University of Medicine and Science
Diseases
Obesity
NCT number
NCT04725058

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 3 Feb 2020 to the primary completion date, 28 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Currently on a weight loss medication (orlistat, lorcaserin, and phentermine/topiramate-ER, phenetermine, diethylpropion, phendimetrazine and benzphetamine)
  • Currently on metformin or topiramate primarily prescribed for weight loss

Other illness

  • Those with mental illness, substance abuse issues as well as other illnesses who are unable to follow directions related to the study or becomes disruptive to the overall group

Lab values

  • Patients who have had bariatric surgery less than a year from time of enrollment
    • Females \<50 years of age and Males \<40 years of age are not eligible to participate in the sub-study that involves getting a Coronary Artery Calcium (CAC) scan done at the Lundquist Institute.

Age

  • Age \<18

Other

  • BMI\< 30 kg/m2
  • Unwilling to sing consent form
  • Currently participating in another obesity treatment program
  • Currently pregnant
  • Ineligible to receive care at LAC-DHS

Criteria the registry did not label

  • Inclusion
    • Age ≥ 18
    • BMI ≥ 30 kg/m2
    • Male, Female, LGBT
    • Any ethnicity
    • Interested in weight loss and be open to being randomized in either a medical group visit arm or dietitian-led arm (willingly agree to sign consent form)
    • Currently within or be eligible to receive care at LAC-DHS and be empaneled to have a primary care provider (PCP) who can adjust their medicines including anti-hypertensive and diabetic medications if needed.
    • If had stopped taking weight loss medication (orlistat, lorcaserin, and phentermine/topiramate-ER, phenetermine, diethylpropion, phendimetrazine and benzphetamine) for at least 2 months prior enrollment
    • If had stopped taking supplements advertised to increase weight loss at least 3 months prior enrollment
    • Females \>50 years of age and Males \>40 years of age meet inclusion criteria to participate in the sub-study that involves getting a Coronary Artery Calcium (CAC) scan done at the Lundquist Institute.

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Charles R. Drew University of Medicine and Science
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.