PRECISION: Culturally Adapted Dietary Clinical Trial in PR

• Sponsor: Harvard School of Public Health (HSPH) (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05962372
• Collaborator: FDI Clinical Research (Other), Yale University (Other), Broad Institute (Other)
• Enrollment: 350
• Arms: 2
• Anticipated Duration (Months): 60

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2; Obesity; Hypertension; Dyslipidemias; High Triglycerides; High Blood Glucose; Abdominal Obesity	Behavioral: Culturally tailored food and diet advice; Behavioral: Standard healthy eating advice	N/A

Detailed Description

This 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 24-month, 2-arm intervention among 350 adults (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 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 + a blend of canola and soybean), 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 6 months, reinforced with daily text messages for 12 months, and monthly supermarket vouchers for 18 months. From months 18-24, we will monitor maintenance of behavior (no food/voucher or counseling), with support from the nutritionist available, and cues-to-action texts. Investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures. The two co-primary outcomes are changes in ASCVD score and in cardiometabolic improvement score.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Participants will be unaware of which educational messages are considered intervention or control. Investigators will not be in contact with participants and will only receive coded data. Outcome assessor will be unaware of treatment allocation of participant. Senior investigators, Research Assistants, and laboratory personnel will be blinded to the participants' group allocation.
• Primary Purpose: Prevention
• Official Title: Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)
• Anticipated Study Start Date: Aug 15, 2023
• Anticipated Primary Completion Date: Aug 15, 2028
• Anticipated Study Completion Date: Aug 15, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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; Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
Active Comparator: Control 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 supermarket vouchers (no 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; 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.

Outcome Measures

Primary Outcome Measures

1. 10-year risk score for a first atherosclerotic CVD event (ASCVD score) [24 months]

   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%.

2. Cardiometabolic Improvement Score (CIS) [24 months]

   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.

Secondary Outcome Measures

1. Changes in diet quality score [6; 12; 18; 24 months]

   Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)

2. Changes in diet satisfaction: diet satisfaction scale [6; 12; 18; 24 months]

   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)

3. Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat) [6; 12; 18; 24 months]

   Determine the change in servings/week of food groups

4. Change in levels of waist circumference [24 months]

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

5. Change in levels of BMI [24 months]

   Estimate the change in the value of body mass index (kg/m2)

6. Change in levels of blood pressure risk factors [24 months]

   Estimate the change in the value of systolic and diastolic blood pressure (mmHg)

7. Change in levels of metabolic risk factors [24 months]

   Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 30-65 y 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:

7. elevated BMI

8. elevated waist circumference

9. self-reported physician-diagnosed hypertension or use of hypertension medication or measured high blood pressure at the baseline visit

10. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the baseline visit

11. 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 (at the day of the interview).

2. Currently not living in Puerto Rico or not lived in 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), to vegetable oils (i.e.: corn, olive, canola), or to fresh produce

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Harvard School of Public Health (HSPH)
• FDI Clinical Research
• Yale University
• Broad Institute

Investigators

• Principal Investigator: Josiemer Mattei, PhD, MPH, Harvard Chan School of Public Health
• Study Director: Jose F Rodriguez Orengo, PhD, FDI Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Josiemer Mattei, Donald and Sue Pritzker Associate Professor of Nutrition, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT05962372
• Other Study ID Numbers: IRB23-0951
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 28, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Obesity; Diabetes Mellitus, Type 2; Dyslipidemias; Obesity, Abdominal; Hypertriglyceridemia; Hyperglycemia

Study Results

No Results Posted as of Jul 28, 2023