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| Name | Class |
|---|---|
| FDI Clinical Research | OTHER |
| Yale University | OTHER |
| Broad Institute of MIT and Harvard | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 | Active Comparator | 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 assistance to purchase healthy 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally tailored food and diet advice | Behavioral | Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| 10-year risk score for a first atherosclerotic CVD event (ASCVD score) | 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%. | 6; 12; 18; 24 months |
| Cardiometabolic Improvement Score (CIS) | 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. | 6; 12; 18; 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in diet quality score | Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality) | 6; 12; 18; 24 months |
| Changes in diet satisfaction: diet satisfaction scale |
| Measure | Description | Time Frame |
|---|---|---|
| Change in social connectedness score | Estimate the change in social connectedness score from the Social Connectedness Scale/Social Assurance Scale | 6; 12; 18; 24 months |
| Change in social support score |
Inclusion Criteria:
Age 30-65y 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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sylvia Lillquist, MS, RDN, MPH | Contact | 954-243-1174 | sylvia.lillquist@fdipr.com |
| Name | Affiliation | Role |
|---|---|---|
| Josiemer Mattei, PhD, MPH | Harvard Chan School of Public Health | Principal Investigator |
| Jose F Rodriguez Orengo, PhD | FDI Clinical Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FDI Clinical Research | Recruiting | San Juan | 00926 | Puerto Rico |
IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control by contacting study investigators.
10 years
The requested data will be shared with investigators via a secured, password-protected software website, upon request.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D015228 | Hypertriglyceridemia |
| D006943 | Hyperglycemia |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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.
| Standard healthy eating advice | Behavioral | 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. |
|
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)
| 6; 12; 18; 24 months |
| Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat) | Determine the change in servings/week of food groups | 6; 12; 18; 24 months |
| Change in levels of waist circumference | Estimate the change in the value of waist circumference (cm) | 6; 12; 18; 24 months |
| Change in levels of BMI | Estimate the change in the value of body mass index (kg/m2) | 6; 12; 18; 24 months |
| Change in levels of blood pressure risk factors | Estimate the change in the value of systolic and diastolic blood pressure (mmHg) | 6; 12; 18; 24 months |
| Change in levels of metabolic risk factors | Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL) | 6; 12; 18; 24 months |
| Change in food security status | Estimate the change in food security status assessed by the USDA Food Security Module | 6; 12; 18; 24 months |
| Change in self-efficacy score | Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale | 6; 12; 18; 24 months |
Estimate the change in social support score from the 12-item Social Support Scale
| 6; 12; 18; 24 months |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D006949 | Hyperlipidemias |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |