Clinical Trials Directory

Trials / Completed

CompletedNCT03975556

Culturally-Adapted Diet for Puerto Rican Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Harvard School of Public Health (HSPH) · Academic / Other
Sex
All
Age
25 Years – 65 Years
Healthy volunteers
Accepted

Summary

This pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.

Detailed description

This pilot intervention will culturally-tailor a diet to the Puerto Rican adult population based on staple foods as well as culturally-appropriate strategies to reduce cardiometabolic risk factors of type 2 diabetes and obesity. Based on preliminary results from studies in the island, investigators will conduct a 4-month, 2-arm intervention among 200 adults (100 per arm) ages 25-65 living in Puerto Rico with at least 2 of 5 cardiometabolic risk factors. The two arms are: (1) intervention group consisting of culturally-appropriate advice in an initial individual session with daily text messages for 2 months (delivery phase); (2) control arm of standard general nutritional advice at the initial individual session, and text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. Investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.

Conditions

Interventions

TypeNameDescription
BEHAVIORALCulturally tailored food and diet advicePuerto 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 adviceStandard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations

Timeline

Start date
2019-07-01
Primary completion
2021-06-30
Completion
2021-06-30
First posted
2019-06-05
Last updated
2021-07-23

Locations

1 site across 1 country: Puerto Rico

Source: ClinicalTrials.gov record NCT03975556. Inclusion in this directory is not an endorsement.