Culturally Adapted Dietary Clinical Trial in PR

Launched by HARVARD SCHOOL OF PUBLIC HEALTH (HSPH) · Jul 21, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a specially designed diet that takes into account the cultural preferences of people in Puerto Rico can help reduce health risks related to conditions like obesity, high blood pressure, and high blood sugar. The goal is to create a diet that is not only effective but also easy for people to follow in their daily lives, which could lead to better heart health and lower chances of developing type 2 diabetes.

To participate in this trial, you need to be between 30 and 65 years old, living in Puerto Rico for at least a year, and have a mobile phone that can receive text messages since you'll get daily updates and information through texts. It’s important that you have at least one health issue related to weight or blood pressure, but you should not be diagnosed with diabetes or have certain allergies or conditions that could affect your ability to eat the foods involved in the study. If you join, you can expect to follow the culturally adapted diet and contribute to important research that could benefit many people in the community.

Gender

ALL

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