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

Charles Drew University of Medicine and Science

Status: Active, not recruiting

Conditions: Obesity

Treatments: Other: Medical Group Visit; Other: Dietitian Individual Visit

Study type: Interventional

Funder types: Other

Identifiers

NCT04725058

1443169

Details and patient eligibility

About

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.

Full description

After being informed about the study and potential risks, all study participants giving written informed consent will be screened to determine eligibility for study entry. At week 0, study participants who meet the eligibility requirements will be randomized in a blind manner (participant only) in a 3:1 block ratio. The study will randomize 750 subjects to the composite group visit and 250 subjects to the dietitian-led group into a 12-months duration study.

For Aim 2: A subset of 200 participants who identify as female and over 50 years old and males over 40 years old randomized to either the composite group arm or the dietitian-led arm will have the option to take part in a sub-study that involves getting a Coronary Artery Calcium (CAC) scan done at the Lundquist Institute. The first 125 subjects in the composite group arm and the first 75 subjects in the dietitian-led arm that express interest and want to undergo CAC scanning and perivascular fat measurements at baseline and at 12-months of intervention will need to sign a separate consent for these procedures. CAC scan readers will be blind to the assigned group. A group of 100 subjects not participating in the aim 1 intervention will be able to join the study under the control group. These participants will not be randomly assigned.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Exclusion Criteria:

• Age <18
• BMI< 30 kg/m2
• Unwilling to sing consent form
• Currently participating in another obesity treatment program
• 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
• Currently pregnant
• Ineligible to receive care at LAC-DHS
• 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,000 participants in 2 patient groups

Medical Group Visit

Experimental group

Description:

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

Treatment:

Other: Medical Group Visit

Dietitian-Led Visit

Experimental group

Description:

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

Treatment:

Other: Dietitian Individual Visit