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Culturally Adapted Dietary Clinical Trial in PR (PRECISION)

Primary Purpose

Diabetes Mellitus, Type 2, Obesity, Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Culturally tailored food and diet advice
Standard healthy eating advice
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age 30-65 y 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 (at the day of the interview). Currently not living in Puerto Rico or not lived in 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), to vegetable oils (i.e.: corn, olive, canola), or to fresh produce

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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%.
    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.

    Secondary Outcome Measures

    Changes in diet quality score
    Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
    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)
    Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
    Determine the change in servings/week of food groups
    Change in levels of waist circumference
    Estimate the change in the value of waist circumference (cm)
    Change in levels of BMI
    Estimate the change in the value of body mass index (kg/m2)
    Change in levels of blood pressure risk factors
    Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
    Change in levels of metabolic risk factors
    Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    October 12, 2023
    Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    FDI Clinical Research, Yale University, Broad Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05962372
    Brief Title
    Culturally Adapted Dietary Clinical Trial in PR
    Acronym
    PRECISION
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 15, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2028 (Anticipated)
    Study Completion Date
    August 15, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Harvard School of Public Health (HSPH)
    Collaborators
    FDI Clinical Research, Yale University, Broad Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose, Abdominal Obesity

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes 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.
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Culturally tailored food and diet advice
    Intervention Description
    Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Standard healthy eating advice
    Intervention Description
    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 Measure Information:
    Title
    10-year risk score for a first atherosclerotic CVD event (ASCVD score)
    Description
    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%.
    Time Frame
    24 months
    Title
    Cardiometabolic Improvement Score (CIS)
    Description
    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.
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Changes in diet quality score
    Description
    Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
    Time Frame
    6; 12; 18; 24 months
    Title
    Changes in diet satisfaction: diet satisfaction scale
    Description
    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)
    Time Frame
    6; 12; 18; 24 months
    Title
    Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
    Description
    Determine the change in servings/week of food groups
    Time Frame
    6; 12; 18; 24 months
    Title
    Change in levels of waist circumference
    Description
    Estimate the change in the value of waist circumference (cm)
    Time Frame
    24 months
    Title
    Change in levels of BMI
    Description
    Estimate the change in the value of body mass index (kg/m2)
    Time Frame
    24 months
    Title
    Change in levels of blood pressure risk factors
    Description
    Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
    Time Frame
    24 months
    Title
    Change in levels of metabolic risk factors
    Description
    Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age 30-65 y 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 (at the day of the interview). Currently not living in Puerto Rico or not lived in 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), to vegetable oils (i.e.: corn, olive, canola), or to fresh produce
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Josiemer Mattei, PhD, MPH
    Phone
    617-432-3017
    Email
    jmattei@hsph.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jose F Rodriguez Orengo, PhD
    Phone
    7877221248
    Email
    jrodriguez@fdipr.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Josiemer Mattei, PhD, MPH
    Organizational Affiliation
    Harvard Chan School of Public Health
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Jose F Rodriguez Orengo, PhD
    Organizational Affiliation
    FDI Clinical Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IPD will be managed and distributed observing NIH and IRB policies on the dissemination and sharing of research results. Study information and requests for data will be available immediately upon the data being de-identified and properly revised for quality control by contacting study investigators.
    IPD Sharing Time Frame
    10 years
    IPD Sharing Access Criteria
    The requested data will be shared with investigators via a secured, password-protected software website, upon request.

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