Culturally Adapted Dietary Clinical Trial in PR

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorHarvard School of Public Health (HSPH)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Under 30 or over 65 years of age (on the day of the interview).

Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years

Institutionalized

Not able to answer questions without assistance

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

Change in levels of waist circumference

Estimate the change in the value of waist circumference (cm)

Time frame
6; 12; 18; 24 months

Other outcomes

1

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
2

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Harvard School of Public Health (HSPH)

Lead sponsor

Yale University

Collaborator

Broad Institute of MIT and Harvard

Collaborator

Puerto Rico Consortium for Clinical Investigations

Collaborator