Culturally Adapted Dietary Clinical Trial in PR

Official title

Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)

Overview

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

• Behavioral Culturally 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.
• Behavioral Standard 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.

Primary outcome measures

• 10-year risk score for a first atherosclerotic CVD event (ASCVD score) [Time frame: 6; 12; 18; 24 months]
• Cardiometabolic Improvement Score (CIS) [Time frame: 6; 12; 18; 24 months]

Secondary outcome measures (9)

• Changes in diet quality score [Time frame: 6; 12; 18; 24 months]
• Changes in diet satisfaction: diet satisfaction scale [Time frame: 6; 12; 18; 24 months]
• Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat) [Time frame: 6; 12; 18; 24 months]
• Change in levels of waist circumference [Time frame: 6; 12; 18; 24 months]
• Change in levels of BMI [Time frame: 6; 12; 18; 24 months]
• Change in levels of blood pressure risk factors [Time frame: 6; 12; 18; 24 months]
• Change in levels of metabolic risk factors [Time frame: 6; 12; 18; 24 months]
• Change in food security status [Time frame: 6; 12; 18; 24 months]
• Change in self-efficacy score [Time frame: 6; 12; 18; 24 months]

Eligibility criteria

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:

• elevated BMI
• elevated waist circumference
• self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit
• self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit
• self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia

Exclusion criteria

• 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
• Not having at least 1 of the five listed metabolic criteria
• Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory
• Self-reported pregnancy
• Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status
• Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce
• Living with another person participating in the study
• Participating in another research study that conflicts with PRECISION

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

Puerto Rico · 1 center

• Puerto Rico Consortium for Clinical Investigation — San Juan

Identifiers

NCT: NCT05962372 · IRB23-0951

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗