Abdominal Obesity, Diabetes Mellitus, Type 2, Dyslipidemias, High Blood Glucose, High Triglycerides, Hypertension, Obesity
Conditions
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.
Detailed description
This intervention will culturally tailor a diet to the adult population in Puerto Rico based on staple foods as well as culturally appropriate strategies to reduce cardiometabolic risk factors. Based on preliminary results from studies on the island, investigators will conduct a 24-month, 2-arm intervention among 250-350 adults (125-175 per arm) ages 30-65 living in Puerto Rico with at least 1 of 5 cardiometabolic risk factors. The two arms are (1) intervention group with culturally-tailored portion-control Mediterranean Diet-like advice through monthly individual counseling for 12 months, reinforced with daily text messages for 12 months, and a monthly household supply of legumes, vegetable oils, and locally sourced assorted fruit and vegetables for 18 months; (2) control arm with portion-control standard non-tailored nutritional counseling in monthly individual sessions for 12 months, reinforced with daily text messages for 12 months, and monthly assistance to purchase healthy foods for 18 months. From months 18-24, we will monitor behavior maintenance (no food/voucher or counseling), with support from the nutritionist, and cues-to-action texts. Investigators will measure changes in cardiometabolic risk factors and metrics of eating behaviors and psychological factors. The two co-primary outcomes are changes in ASCVD score and cardiometabolic improvement score.
Interventions
BEHAVIORALCulturally tailored food and diet advice
Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
BEHAVIORALStandard healthy eating advice
Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate For A Healthy Puerto Rico dietary recommendations.
Sponsors
Harvard School of Public Health (HSPH)
Yale University
Broad Institute of MIT and Harvard
Puerto Rico Consortium for Clinical Investigations
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participants will be unaware of which educational messages are considered intervention or control. Investigators will not be in contact with participants and will only receive coded data. Outcome assessor will be unaware of treatment allocation of participant. Senior investigators, Research Assistants, and laboratory personnel will be blinded to the participants' group allocation.
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10-year risk score for a first atherosclerotic CVD event (ASCVD score) | 6; 12; 18; 24 months | Estimate the change in first atherosclerotic CVD event (ASCVD) score; the score is calculated using the Pooled Cohort Equation which accounts for biological sex, age, race, total cholesterol, HDL-C, systolic blood pressure, treatment for high blood pressure, current diabetes diagnosis, and smoking status. Scores are expressed as percentage (0-100) with higher scores indicative of higher 10-year risk for ASCVD event. It is categorized as low-risk \<5%; borderline risk 5% to 7.4%; intermediate risk 7.5% to 19.9%; and high risk ≥20%. |
| Cardiometabolic Improvement Score (CIS) | 6; 12; 18; 24 months | Estimate the change in the score; calculated as the added number of risk factors changed over a predefined value; range of 0 to 10; from less to more improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in diet quality score | 6; 12; 18; 24 months | Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality) |
| Changes in diet satisfaction: diet satisfaction scale | 6; 12; 18; 24 months | Determine the change in the score of the Diet Satisfaction Questionnaire (DSat-45) (range 45-225; from lowest to highest satisfaction) and its summed seven subscales (ranges 5-40) |
| Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat) | 6; 12; 18; 24 months | Determine the change in servings/week of food groups |
| Change in levels of waist circumference | 6; 12; 18; 24 months | Estimate the change in the value of waist circumference (cm) |
| Change in levels of BMI | 6; 12; 18; 24 months | Estimate the change in the value of body mass index (kg/m2) |
| Change in levels of blood pressure risk factors | 6; 12; 18; 24 months | Estimate the change in the value of systolic and diastolic blood pressure (mmHg) |
| Change in levels of metabolic risk factors | 6; 12; 18; 24 months | Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL) |
| Change in food security status | 6; 12; 18; 24 months | Estimate the change in food security status assessed by the USDA Food Security Module |
| Change in self-efficacy score | 6; 12; 18; 24 months | Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale |
Countries
Puerto Rico
Contacts
CONTACTNatalia Torres, BS
PRINCIPAL_INVESTIGATORJosiemer Mattei, PhD, MPH
Harvard Chan School of Public Health
STUDY_DIRECTORAmarilys F Sylva, PhD
Puerto Rico Consortium for Clinical Investigations
Outcome results
None listed