An interventional study of Culturally tailored food and diet advice and Standard healthy eating advice in Diabetes Mellitus, Type 2, Obesity and Hypertension, sponsored by Harvard School of Public Health (HSPH). Recruiting at 1 site in Puerto Rico. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Prevention
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Having at least one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Culturally tailored food and diet advice
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.
Behavioral: Standard healthy eating advice
Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
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.
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%.
Time frame: 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.
Time frame: 6; 12; 18; 24 months
Changes in diet quality score
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Time frame: 6; 12; 18; 24 months
Changes in diet satisfaction: diet satisfaction scale
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)
Time frame: 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
Time frame: 6; 12; 18; 24 months
Change in levels of waist circumference
Estimate the change in the value of waist circumference (cm)
Time frame: 6; 12; 18; 24 months
Change in levels of BMI
Estimate the change in the value of body mass index (kg/m2)
Time frame: 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)
Time frame: 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)
Time frame: 6; 12; 18; 24 months
Change in food security status
Estimate the change in food security status assessed by the USDA Food Security Module
Time frame: 6; 12; 18; 24 months
Change in self-efficacy score
Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale
Time frame: 6; 12; 18; 24 months
Change in social connectedness score
Estimate the change in social connectedness score from the Social Connectedness Scale/Social Assurance Scale
Time frame: 6; 12; 18; 24 months
Change in social support score
Estimate the change in social support score from the 12-item Social Support Scale
Time frame: 6; 12; 18; 24 months
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: 10 years
Access criteria: The requested data will be shared with investigators via a secured, password-protected software website, upon request.
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for May 2029, 60 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 60 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Harvard School of Public Health (HSPH) →