xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05962372</url>
    </required_header>
    <id_info>
      <org_study_id>IRB23-0951</org_study_id>
      <nct_id>NCT05962372</nct_id>
    </id_info>
    <brief_title>Culturally Adapted Dietary Clinical Trial in PR</brief_title>
    <acronym>PRECISION</acronym>
    <official_title>Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Harvard School of Public Health (HSPH)</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>FDI Clinical Research</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Broad Institute</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Harvard School of Public Health (HSPH)</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This project will determine whether a diet culturally-adapted to Puerto Ricans can&#xD;
        effectively decrease cardiometabolic risk for diabetes and obesity. This will help define a&#xD;
        culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2&#xD;
        diabetes and obesity outcomes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This intervention will culturally-tailor a diet to the Puerto Rican adult population based on&#xD;
        staple foods as well as culturally-appropriate strategies to reduce cardiometabolic risk&#xD;
        factors of type 2 diabetes and obesity. Based on preliminary results from studies in the&#xD;
        island, investigators will conduct a 24-month, 2-arm intervention among 350 adults (175 per&#xD;
        arm) ages 30-65 living in Puerto Rico with at least 1 of 5 cardiometabolic risk factors. The&#xD;
        two arms are: (1) intervention group with culturally-tailored portion-control Mediterranean&#xD;
        Diet-like advice through monthly individual counseling for 6 months, reinforced with daily&#xD;
        text messages for 12 months, and a monthly household supply of legumes (i.e., beans and&#xD;
        peanuts), vegetable oils (i.e., olive + a blend of canola and soybean), and locally-sourced&#xD;
        assorted fruit and vegetables for 18 months; (2) control arm with portion-control standard&#xD;
        non-tailored nutritional counseling in monthly individual sessions for 6 months, reinforced&#xD;
        with daily text messages for 12 months, and monthly supermarket vouchers for 18 months. From&#xD;
        months 18-24, we will monitor maintenance of behavior (no food/voucher or counseling), with&#xD;
        support from the nutritionist available, and cues-to-action texts. Investigators will measure&#xD;
        changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.&#xD;
        The two co-primary outcomes are changes in ASCVD score and in cardiometabolic improvement&#xD;
        score.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 15, 2028</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
      <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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>10-year risk score for a first atherosclerotic CVD event (ASCVD score)</measure>
      <time_frame>24 months</time_frame>
      <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 &lt;5%; borderline risk 5% to 7.4%; intermediate risk 7.5% to 19.9%; and high risk ≥20%.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cardiometabolic Improvement Score (CIS)</measure>
      <time_frame>24 months</time_frame>
      <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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Changes in diet quality score</measure>
      <time_frame>6; 12; 18; 24 months</time_frame>
      <description>Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in diet satisfaction: diet satisfaction scale</measure>
      <time_frame>6; 12; 18; 24 months</time_frame>
      <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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)</measure>
      <time_frame>6; 12; 18; 24 months</time_frame>
      <description>Determine the change in servings/week of food groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in levels of waist circumference</measure>
      <time_frame>24 months</time_frame>
      <description>Estimate the change in the value of waist circumference (cm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in levels of BMI</measure>
      <time_frame>24 months</time_frame>
      <description>Estimate the change in the value of body mass index (kg/m2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in levels of blood pressure risk factors</measure>
      <time_frame>24 months</time_frame>
      <description>Estimate the change in the value of systolic and diastolic blood pressure (mmHg)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in levels of metabolic risk factors</measure>
      <time_frame>24 months</time_frame>
      <description>Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">350</enrollment>
    <condition>Diabetes Mellitus, Type 2</condition>
    <condition>Obesity</condition>
    <condition>Hypertension</condition>
    <condition>Dyslipidemias</condition>
    <condition>High Triglycerides</condition>
    <condition>High Blood Glucose</condition>
    <condition>Abdominal Obesity</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Culturally tailored food and diet advice</intervention_name>
      <description>Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard healthy eating advice</intervention_name>
      <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.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 30-65 y old at the time of enrollment&#xD;
  &#xD;
            2. Non-institutionalized&#xD;
  &#xD;
            3. Living in PR at the time of recruitment and for at least the previous year and not&#xD;
               planning to move from the island within the next 3 years&#xD;
  &#xD;
            4. Able to answer questions without assistance&#xD;
  &#xD;
            5. Having a cellphone with the capacity to receive text messages and be willing to&#xD;
               receive daily text messages from the study on the designated cellphone number&#xD;
  &#xD;
            6. Having at least one of the following:&#xD;
  &#xD;
                 1. elevated BMI&#xD;
  &#xD;
                 2. elevated waist circumference&#xD;
  &#xD;
                 3. self-reported physician-diagnosed hypertension or use of hypertension medication&#xD;
                    or measured high blood pressure at the baseline visit&#xD;
  &#xD;
                 4. self-reported physician-diagnosed pre-diabetes or measured pre-diabetes at the&#xD;
                    baseline visit&#xD;
  &#xD;
                 5. self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or&#xD;
                    laboratory values confirming dyslipidemia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Under 30 or over 65 years of age (at the day of the interview).&#xD;
  &#xD;
            2. Currently not living in Puerto Rico or not lived in the island for at least 1 year or&#xD;
               planning to move within 3 years&#xD;
  &#xD;
            3. Institutionalized&#xD;
  &#xD;
            4. Not able to answer questions without assistance&#xD;
  &#xD;
            5. Not having at least 1 of the five listed metabolic criteria&#xD;
  &#xD;
            6. Self-reported physician-diagnosed type 1 or type 2 diabetes or use of diabetes&#xD;
               medication (including insulin) or diabetes-diagnosis values confirmed by laboratory&#xD;
  &#xD;
            7. Self-reported pregnancy&#xD;
  &#xD;
            8. Gastrointestinal or chronic condition that would impact eating behaviors or&#xD;
               nutritional status&#xD;
  &#xD;
            9. Intolerance or allergies to legumes (i.e.: beans and nuts), to vegetable oils (i.e.:&#xD;
               corn, olive, canola), or to fresh produce&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>30 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Josiemer Mattei, PhD, MPH</last_name>
      <role>Principal Investigator</role>
      <affiliation>Harvard Chan School of Public Health</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jose F Rodriguez Orengo, PhD</last_name>
      <role>Study Director</role>
      <affiliation>FDI Clinical Research</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Josiemer Mattei, PhD, MPH</last_name>
      <phone>617-432-3017</phone>
      <email>jmattei@hsph.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jose F Rodriguez Orengo, PhD</last_name>
      <phone>7877221248</phone>
      <email>jrodriguez@fdipr.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
      <investigator_full_name>Josiemer Mattei</investigator_full_name>
      <investigator_title>Donald and Sue Pritzker Associate Professor of Nutrition</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
      <mesh_term>Dyslipidemias</mesh_term>
      <mesh_term>Obesity, Abdominal</mesh_term>
      <mesh_term>Hypertriglyceridemia</mesh_term>
      <mesh_term>Hyperglycemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_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_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>10 years</ipd_time_frame>
      <ipd_access_criteria>The requested data will be shared with investigators via a secured, password-protected software website, upon request.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05962372
  org study id: IRB23-0951
  nct id: NCT05962372
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  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.
  measure: 10-year risk score for a first atherosclerotic CVD event (ASCVD score)
  time frame: 24 months
  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%.
  measure: Cardiometabolic Improvement Score (CIS)
  time frame: 24 months
  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.
  measure: Changes in diet quality score
  time frame: 6; 12; 18; 24 months
  description: Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
  measure: Changes in diet satisfaction: diet satisfaction scale
  time frame: 6; 12; 18; 24 months
  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)
  measure: Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
  time frame: 6; 12; 18; 24 months
  description: Determine the change in servings/week of food groups
  measure: Change in levels of waist circumference
  time frame: 24 months
  description: Estimate the change in the value of waist circumference (cm)
  measure: Change in levels of BMI
  time frame: 24 months
  description: Estimate the change in the value of body mass index (kg/m2)
  measure: Change in levels of blood pressure risk factors
  time frame: 24 months
  description: Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
  measure: Change in levels of metabolic risk factors
  time frame: 24 months
  description: Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)
  arm group label: Intervention
  arm group type: Experimental
  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 group label: Control
  arm group type: Active Comparator
  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: Culturally tailored food and diet advice
  description: Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Standard healthy eating advice
  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.
  arm group label: Control
  criteria: 
  gender: All
  gender based: Yes
  minimum age: 30 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Josiemer Mattei, PhD, MPH
  role: Principal Investigator
  affiliation: Harvard Chan School of Public Health
  last name: Jose F Rodriguez Orengo, PhD
  role: Study Director
  affiliation: FDI Clinical Research
  last name: Josiemer Mattei, PhD, MPH
  phone: 617-432-3017
  email: jmattei@hsph.harvard.edu
  last name: Jose F Rodriguez Orengo, PhD
  phone: 7877221248
  email: jrodriguez@fdipr.com
  responsible party type: Principal Investigator
  investigator affiliation: Harvard School of Public Health (HSPH)
  investigator full name: Josiemer Mattei
  investigator title: Donald and Sue Pritzker Associate Professor of Nutrition
  mesh term: Obesity
  mesh term: Diabetes Mellitus, Type 2
  mesh term: Dyslipidemias
  mesh term: Obesity, Abdominal
  mesh term: Hypertriglyceridemia
  mesh term: Hyperglycemia
  sharing ipd: Yes
  ipd 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 info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 10 years
  ipd access criteria: The requested data will be shared with investigators via a secured, password-protected software website, upon request.