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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT03683134
Eligibility Criteria:
Inclusion Criteria:
* Enrolled in Auburn University's health insurance program during the course of the study or a dependent of the enrollee during the course of the study
* BMI \>24.9 (kg/m2)
* AND Meets two or more of the following
* Screening values classified in the "yellow" or "red" zone for:
* Systolic blood pressure (mmHg): Yellow zone: ≥140, Red zone: ≥160;
* Diastolic Blood pressure (mmHg): Yellow zone: ≥90, Red zone: ≥ 100;
* Fasting blood glucose (mm/dL): Yellow zone: ≥100, Red zone: ≥ 126
* Blood glucose (random) (mg/dL): Yellow zone: 140-200, Red zone \> 200
* Total Cholesterol (mg/dL): Yellow zone: ≥200, red zone: ≥250
* Have a pre-existing diagnosis of hypertension, pre-diabetes, or hypercholesterolemia
* Current smoker (≥1 cigarette/day)
* Are: male (age: 55-80) or female (age: 60-80)
* A family history of premature coronary heart disease
* High risk ethnicity: Black, African American, American Indians/Alaska Natives, Non-Hispanic blacks, Mexican-Americans, Asian, Hispanic/Latino
Exclusion Criteria:
* Minors that are less than 19 years of age
* Individuals who are not enrolled in the Auburn University health insurance program for the 2016 plan year at baseline and have not yet completed initial visit
* Individuals who have not completed their 2015 "Healthy Tigers" biometric screening between January 1st and December 31st, 2015 (these can be completed by the "Healthy Tigers" staff or by submitting a healthcare provider form from the individuals' physician to the "Healthy Tigers" office), unless enrolled in "TigerMeds".
* Individuals who are pregnant or who intend to become pregnant during the 12-week health and wellness challenge.
* Individuals who anticipate absence or travel throughout the study that would interfere with their ability to complete the analysis at the mid-point and end of challenge.
* Patients with a peanut, tree nut, or olive oil food allergy or intolerance.
* Patients who are unable or unwilling to travel to Auburn University main campus for live health and wellness challenge events, individual assessments, personal appointments, and pre- and post- data collection
* Individuals who have NOT been stabilized on medication to treat or manage high blood pressure, high cholesterol, dyslipidemia, or pre diabetes for at least 12 weeks prior to the study.
* Patients who do not have access to the internet and therefore unable to complete the education portion of the study
* Individuals who have a pacemaker
* Patients who decline participation during informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03683134
Study Brief:
Protocol Section:
NCT03683134