Diabetes Mellitus, Type 2PRECISIONNCT05962372
Culturally Adapted Dietary Clinical Trial in PR
A study testing Culturally tailored food and diet advice and Standard healthy eating advice in people with Diabetes Mellitus, Type 2 and Obesity, run by Harvard School of Public Health (HSPH) at 1 site in Puerto Rico.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Obesity, Hypertension
- What is being tested?
- Culturally tailored food and diet advice and Standard healthy eating advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 2 May 2024to 2 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-65y 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:
Show all 11Show fewer
- 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
Who cannot join
- Under 30 or over 65 years of age (on the day of the interview).
- Currently not living in Puerto Rico or not lived on 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
Show all 11Show fewer
- 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), vegetable oils (i.e.: corn, olive, canola), or fresh produce
- Living with another person participating in the study
- Participating in another research study that conflicts with PRECISION
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico1 site, 1 recruiting
- Recruiting
Puerto Rico Consortium for Clinical Investigation
San Juan, 00926
Natalia Torres, BS, 787-523-1593, natalia.torres@prcci.org
Amarilys F Sylva, PhD
About this study
Official title: Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)
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.
Read the 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 assistance to purchase healthy foods 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.
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose
- Being tested
- Culturally tailored food and diet advice, Standard healthy eating advice
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, Hypertriglyceridemia, Hyperglycemia, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally tailored food and diet adviceBehavioural
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 adviceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Culturally tailored food and diet advice |
| Control | Active comparator | 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 assistance to purchase healthy 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. Receives: Behavioral: Standard healthy eating advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 6; 12; 18; 24 months
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.
Measured: 6; 12; 18; 24 months
Secondary outcomes (9)
Changes in diet quality score
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Measured: 6; 12; 18; 24 months
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)
Measured: 6; 12; 18; 24 months
Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
Determine the change in servings/week of food groups
Measured: 6; 12; 18; 24 months
Change in levels of waist circumference
Estimate the change in the value of waist circumference (cm)
Measured: 6; 12; 18; 24 months
Change in levels of BMI
Estimate the change in the value of body mass index (kg/m2)
Measured: 6; 12; 18; 24 months
Change in levels of blood pressure risk factors
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Measured: 6; 12; 18; 24 months
Change in levels of metabolic risk factors
Estimate the change in the value of glucose, triglycerides, total cholesterol, LDL, HDL (mg/dL)
Measured: 6; 12; 18; 24 months
Change in food security status
Estimate the change in food security status assessed by the USDA Food Security Module
Measured: 6; 12; 18; 24 months
Change in self-efficacy score
Estimate the change in self-efficacy score assessed by the Nutritional Self-Efficacy Scale
Measured: 6; 12; 18; 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start2 May 2024
- Primary completion2 May 2029 (estimated)
- Study completion2 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Broad Institute of MIT and Harvard, Puerto Rico Consortium for Clinical Investigations
- Responsible party
- Principal investigator, Josiemer Mattei, Harvard School of Public Health (HSPH)
- Investigators
- Josiemer Mattei, PhD, MPH, Principal investigator, Harvard Chan School of Public HealthAmarilys F Sylva, PhD, Study director, Puerto Rico Consortium for Clinical Investigations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962372
- Sponsor's protocol ID
- IRB23-0951
- Acronym
- PRECISION
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Dietary Clinical Trial in PR: Puerto Rico Evaluation of a Culturally Informed Sustainable Intervention for Optimal Nutrition (PRECISION)
- ClinicalTrials.gov ID
- NCT05962372
- Acronym / sponsor ID
- PRECISION / IRB23-0951
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Yale University, Broad Institute of MIT and Harvard, Puerto Rico Consortium for Clinical Investigations
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 May 2029 (estimated)
- Study completion
- 2 May 2029 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 assistance to purchase healthy foods 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Culturally tailored food and diet adviceIntervention 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 | Active comparator | Behavioral: Standard healthy eating adviceControl 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 assistance to purchase healthy 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 30-65y 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
Key exclusion criteria (11 listed)
- Under 30 or over 65 years of age (on the day of the interview).
- Currently not living in Puerto Rico or not lived on 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally tailored food and diet advicePuerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc. | Behavioural | Intervention |
| Standard healthy eating adviceStandard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate For A Healthy Puerto Rico dietary recommendations. | Behavioural | Control |
Primary outcome
10-year risk score for a first atherosclerotic CVD event (ASCVD score)
Time frame: 6; 12; 18; 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%.
Cardiometabolic Improvement Score (CIS)
Time frame: 6; 12; 18; 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.
9 secondary outcomes
Changes in diet quality score
Time frame: 6; 12; 18; 24 months
Changes in diet satisfaction: diet satisfaction scale
Time frame: 6; 12; 18; 24 months
Changes in intake of pre-specified food groups (fruit; vegetables; legumes; oils; meat; fat)
Time frame: 6; 12; 18; 24 months
Change in levels of waist circumference
Time frame: 6; 12; 18; 24 months
Change in levels of BMI
Time frame: 6; 12; 18; 24 months
Change in levels of blood pressure risk factors
Time frame: 6; 12; 18; 24 months
Change in levels of metabolic risk factors
Time frame: 6; 12; 18; 24 months
Change in food security status
Time frame: 6; 12; 18; 24 months
Change in self-efficacy score
Time frame: 6; 12; 18; 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josiemer Mattei, PhD, MPH principal investigator
Harvard Chan School of Public Health
Amarilys F Sylva, PhD study director
Puerto Rico Consortium for Clinical Investigations
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally tailored food and diet advice and Standard healthy eating advice in people with Diabetes Mellitus, Type 2 and Obesity, run by Harvard School of Public Health (HSPH) at 1 site in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia Torres, BS (787-523-1593, natalia.torres@prcci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-year risk score for a first atherosclerotic CVD event (ASCVD score) (time frame: 6; 12; 18; 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.