Clinical trial NCT05962372: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Obesity
Hypertension
Dyslipidemias
High Triglycerides
High Blood Glucose
Abdominal Obesity
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: FDI Clinical Research
name: Yale University
name: Broad Institute of MIT and Harvard
First posted: 2023-07-27
Enrollment: 350
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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 supermarket vouchers 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.

Eligibility criteria: Inclusion Criteria:

1. Age 30-65y old at the time of enrollment
2. Non-institutionalized
3. 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
4. Able to answer questions without assistance
5. 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
6. Having at least one of the following:

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

Exclusion Criteria:

1. Under 30 or over 65 years of age (on the day of the interview).
2. Currently not living in Puerto Rico or not lived on the island for at least 1 year or planning to move within 3 years
3. Institutionalized
4. Not able to answer questions without assistance
5. Not having at least 1 of the five listed metabolic criteria
6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes medication (including insulin) or diabetes-diagnosis values confirmed by laboratory
7. Self-reported pregnancy
8. Gastrointestinal or chronic condition that would impact eating behaviors or nutritional status
9. Intolerance or allergies to legumes (i.e.: beans and nuts), vegetable oils (i.e.: corn, olive, canola), or fresh produce
10. Living with another person participating in the study
11. Participating in another research study that conflicts with PRECISION

Primary outcomes:
measure: 10-year risk score for a first atherosclerotic CVD event (ASCVD score)
timeFrame: 6; 12; 18; 24 months
measure: Cardiometabolic Improvement Score (CIS)
timeFrame: 6; 12; 18; 24 months
Secondary outcomes:
measure: Changes in diet quality score
timeFrame: 6; 12; 18; 24 months
measure: Changes in diet satisfaction: diet satisfaction scale
timeFrame: 6; 12; 18; 24 months
measure: Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
timeFrame: 6; 12; 18; 24 months
measure: Change in levels of waist circumference
timeFrame: 6; 12; 18; 24 months
measure: Change in levels of BMI
timeFrame: 6; 12; 18; 24 months
measure: Change in levels of blood pressure risk factors
timeFrame: 6; 12; 18; 24 months
measure: Change in levels of metabolic risk factors
timeFrame: 6; 12; 18; 24 months
measure: Change in food security status
timeFrame: 6; 12; 18; 24 months
measure: Change in self-efficacy score
timeFrame: 6; 12; 18; 24 months
Other outcomes:
measure: Change in social connectedness score
timeFrame: 6; 12; 18; 24 months
measure: Change in social support score
timeFrame: 6; 12; 18; 24 months
Locations:
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
Study officials:
affiliation: Harvard Chan School of Public Health
name: Josiemer Mattei, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: FDI Clinical Research
name: Jose F Rodriguez Orengo, PhD
role: STUDY_DIRECTOR
References: