Culturally Adapted Dietary Clinical Trial in PR (PRECISION)
Diabetes Mellitus, Type 2, Obesity, Hypertension
About this trial
This is an interventional prevention trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria: Age 30-65 y old at the time of enrollment Non-institutionalized 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 Able to answer questions without assistance 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 Having at least one of the following: elevated BMI elevated waist circumference self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia Exclusion Criteria: Under 30 or over 65 years of age (at the day of the interview). Currently not living in Puerto Rico or not lived in the island for at least 1 year or planning to move within 3 years Institutionalized Not able to answer questions without assistance Not having at least 1 of the five listed metabolic criteria Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory Self-reported pregnancy Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status Intolerance or allergies to legumes (i.e.: beans and nuts), to vegetable oils (i.e.: corn, olive, canola), or to fresh produce
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention
Control
Intervention group will receive culturally-tailored portion-control Mediterranean-like advice through monthly individual counseling for 6 months, reinforced with daily text messages for 12 months, and a monthly household supply of legumes (i.e., beans and peanuts), vegetable oils (i.e., olive oil + a blend of canola and soybean), and locally sourced assorted fruit and vegetables for 18 months. From months 18 to 24, we will monitor maintenance of behavior (no food or counseling) with support from the nutritionist available.
Control group will receive portion-control standard non-tailored nutritional counseling in monthly individual sessions for 6 months, reinforced with daily text messages for 12 months, and monthly supermarket vouchers (no foods) for 18 months. From months 18 to 24, we will monitor maintenance of behavior (no voucher or counseling), with support from the nutritionist available.