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:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT03975556
Eligibility Criteria:
Inclusion Criteria:
1. Age 25-65 y old at the time of enrollment
2. Non-institutionalized
3. Living in PR at the time of recruitment and for at least the previous year and not planning to move from the island within the next 6 months
4. Able to answer questions without assistance
5. Having a cellphone with the capacity to receive text messages
6. Having at least two of the following:
1. elevated BMI
2. elevated waist circumference
3. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure
4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes
5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia
Exclusion Criteria:
1. Under 25 or over 65 years of age
2. Currently do not live in Puerto Rico or have not lived in PR for at least 1 year or plan to move within 6 months
3. Institutionalized
4. Not able to answer questions without assistance
5. Not having at least 2 of the five listed metabolic criteria
6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin), or diabetes-diagnosis values confirmed by laboratory.
7. Self-reported pregnancy
8. Gastrointestinal or chronic conditions
9. Food intolerance or allergies
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
65 Years
Study:
NCT03975556
Study Brief:
Protocol Section:
NCT03975556