Culturally Adapted Dietary Clinical Trial in PR

Obesity Clinical Trial

— PRECISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962372
• Other study ID #: IRB23-0951
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: May 2, 2029

Study information

• Verified date: May 2024
• Source: Harvard School of Public Health (HSPH)
• Contact: Gabriela Ruiz, MS, RDN
• Phone: 787-309-4207
• Email: gruiz[@]fdipr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 2, 2029
• Est. primary completion date: May 2, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Obesity
• Diabetes Mellitus, Type 2
• Dyslipidemias
• High Blood Glucose
• High Triglycerides
• Hyperglycemia
• Hypertension
• Hypertriglyceridemia
• Obesity
• Obesity, Abdominal

Intervention

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.
• 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.

Locations

Country	Name	City	State
Puerto Rico	FDI Clinical Research	San Juan

Sponsors (4)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Broad Institute, FDI Clinical Research, Yale University

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in social connectedness score	Estimate the change in social connectedness score from the Social Connectedness Scale/Social Assurance Scale	6; 12; 18; 24 months
Other	Change in social support score	Estimate the change in social support score from the 12-item Social Support Scale	6; 12; 18; 24 months
Primary	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%.	6; 12; 18; 24 months
Primary	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.	6; 12; 18; 24 months
Secondary	Changes in diet quality score	Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)	6; 12; 18; 24 months
Secondary	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)	6; 12; 18; 24 months
Secondary	Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)	Determine the change in servings/week of food groups	6; 12; 18; 24 months
Secondary	Change in levels of waist circumference	Estimate the change in the value of waist circumference (cm)	6; 12; 18; 24 months
Secondary	Change in levels of BMI	Estimate the change in the value of body mass index (kg/m2)	6; 12; 18; 24 months
Secondary	Change in levels of blood pressure risk factors	Estimate the change in the value of systolic and diastolic blood pressure (mmHg)	6; 12; 18; 24 months
Secondary	Change in levels of metabolic risk factors	Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)	6; 12; 18; 24 months
Secondary	Change in food security status	Estimate the change in food security status assessed by the USDA Food Security Module	6; 12; 18; 24 months
Secondary	Change in self-efficacy score	Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale	6; 12; 18; 24 months