Eligibility Module

Eligibility Module

The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.

Eligibility Module path is as follows:

Study -> Protocol Section -> Eligibility Module

Eligibility Module


Ignite Creation Date: 2025-12-25 @ 12:09 AM
Ignite Modification Date: 2025-12-25 @ 12:09 AM
NCT ID: NCT04725058
Eligibility 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.
Healthy Volunteers: True
Sex: ALL
Minimum Age: 18 Years
Maximum Age: 90 Years
Study: NCT04725058
Study Brief:
Protocol Section: NCT04725058