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 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT03092960
Eligibility Criteria:
Inclusion Criteria:
* Latino of any race
* BMI \>27 kg/m2
* One or more metabolic syndrome component (high triglycerides, blood pressure, fasting glucose, central obesity, or low HDL cholesterol)
* Primary Care Physician approval of patient study contact
* Able and willing to enroll and provide informed consent, i.e., to meet the time and data collection requirements of the study, be randomized to one of tow study arms, participate in follow-up for 18 months, and authorize the extraction of relevant information form the Electronic Health Record.
Exclusion Criteria:
Medical exclusions:
* Previous diagnosis of diabetes or diabetes diagnosed as a result of fasting blood glucose or hemoglobin A1c levels obtained through study screening;
* Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or treated with radiation or chemotherapy within the past 2 years;
* Inability to walk without the assistance of another person;
* Severe medical co-morbidities that require aggressive treatment: e.g., stage 4 or greater renal disease, class III or greater heart failure, unstable coronary artery disease, liver or renal failure;
* Diagnosis of a terminal illness and/or in hospice care;
* Diagnosis of bipolar disorder or psychotic disorder within the last 2 years, or currently taking a mood stabilizer or antipsychotic medication
* Initiation or change in type or dosing of antidepressant medications within 2 months prior to enrollment (The patient will be re-contacted for a later cohort once his/her regimen has been stable for at least 2 months unless the person declines to participate altogether.)
* Have had or plan to undergo bariatric surgery during the study period
Other exclusions:
* Having no reliable telephone service
* Plan to move out of the area during the study period
* Family/household member of another study participant or of a study staff member
* Investigator discretion for clinical safety or protocol adherence reasons
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03092960
Study Brief:
Protocol Section:
NCT03092960