NCT05962372 Culturally Adapted Dietary Clinical Trial in PR
| NCT ID | NCT05962372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Harvard School of Public Health (HSPH) |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-05-02 |
| Primary Completion | 2029-05-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2024-05-02 with a primary completion date of 2029-05-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This project will determine whether a diet culturally adapted to adults in Puerto Rico can effectively decrease cardiometabolic risk factors. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing cardiovascular, type 2 diabetes, and obesity outcomes.
Eligibility Criteria
Inclusion Criteria: 1. Age 30-65y 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 3 years 4. Able to answer questions without assistance 5. Having a cellphone with the capacity to receive text messages and be willing to receive daily text messages from the study on the designated cellphone number 6. Having at least one 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 at the baseline visit 4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit 5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia Exclusion Criteria: 1. Under 30 or over 65 years of age (on the day of the interview). 2. Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years 3. Institutionalized 4. Not able to answer questions without assistance 5. Not having at least 1 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 condition that would impact eating behaviors or nutritional status 9. Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce 10. Living with another person participating in the study 11. Participating in another research study that conflicts with PRECISION
Contact & Investigator
Josiemer Mattei, PhD, MPH
PRINCIPAL INVESTIGATOR
Harvard Chan School of Public Health
Frequently Asked Questions
Who can join the NCT05962372 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05962372 currently recruiting?
Yes, NCT05962372 is actively recruiting participants. Contact the research team at natalia.torres@prcci.org for enrollment information.
Where is the NCT05962372 trial being conducted?
This trial is being conducted at San Juan, Puerto Rico.
Who is sponsoring the NCT05962372 clinical trial?
NCT05962372 is sponsored by Harvard School of Public Health (HSPH). The principal investigator is Josiemer Mattei, PhD, MPH at Harvard Chan School of Public Health. The trial plans to enroll 250 participants.
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