Diabetes Mellitus, Type 2NCT03975556
Culturally-Adapted Diet for Puerto Rican Adults
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 pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes. Read more about this study
- Who is it for?
- Ages 25 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
- 45 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 1 Jul 2019to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 25-65 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 6 months
- Able to answer questions without assistance
- Having a cellphone with the capacity to receive text messages
- Having at least two 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
- self-reported physician-diagnosed pre-diabetes or measured pre-diabetes
- self-reported physician-diagnosed dyslipidemia or use of lipid-lowering agents or laboratory values confirming dyslipidemia
Who cannot join
- Under 25 or over 65 years of age
- Currently do not live in Puerto Rico or have not lived in PR for at least 1 year or plan to move within 6 months
- Institutionalized
- Not able to answer questions without assistance
- Not having at least 2 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 9Show fewer
- Self-reported pregnancy
- Gastrointestinal or chronic conditions
- Food intolerance or allergies
Trial locations and contacts
1 site in 1 country.
About this study
This pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.
Read the detailed description
This pilot 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 4-month, 2-arm intervention among 200 adults (100 per arm) ages 25-65 living in Puerto Rico with at least 2 of 5 cardiometabolic risk factors. The two arms are: (1) intervention group consisting of culturally-appropriate advice in an initial individual session with daily text messages for 2 months (delivery phase); (2) control arm of standard general nutritional advice at the initial individual session, and text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. Investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.
- 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 dietary recommendations
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group consisting of culturally-appropriate foods and diet advice in an initial individual session followed by daily text messages for 2 months (delivery phase). A reinforcement phase of 2-months will follow to repeat the text messages. Receives: Behavioral: Culturally tailored food and diet advice |
| Control | Active comparator | Control arm of standard portion-control general nutritional and cooking advice at the initial individual session, followed by text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. Receives: Behavioral: Standard healthy eating advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dysregulated cradiometabolic risk factors
Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)
Measured: 4 months
Change in levels of adipose risk factor
Estimate the change in the value of waist circumference (cm)
Measured: 4 months
Change in levels of blood pressure risk factors
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Measured: 4 months
Change in levels of metabolic risk factors
Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)
Measured: 4 months
Secondary outcomes (2)
Changes in diet quality score
Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality)
Measured: 4 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: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jul 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- FDI Clinical Research
- Responsible party
- Principal investigator, Josiemer Mattei, Harvard School of Public Health (HSPH)
- Investigators
- Jose F Rodriguez Orengo, PhD, Study director, FDI Clinical ResearchJosiemer Mattei, PhD, MPH, Principal investigator, Harvard Chan School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975556
- Sponsor's protocol ID
- IRB19-0184
- Status last verified
- Jul 2021
- First submitted
- 30 May 2019
- Last updated
- 23 Jul 2021
- 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.
Publications
Mattei J, Diaz-Alvarez CB, Alfonso C, O'Neill HJ, Rios-Bedoya CF, Malik VS, Godoy-Vitorino F, Cheng C, Spiegelman D, Willett WC, Hu FB, Rodriguez-Orengo JF. Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet. Curr Dev Nutr. 2022 Dec 23;7(1):100022. doi: 10.1016/j.cdnut.2022.100022. eCollection 2023 Jan.
PubMed 37181130
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-Adapted Diet for Puerto Rican Adults
- ClinicalTrials.gov ID
- NCT03975556
- Acronym / sponsor ID
- IRB19-0184
- Conditions
- Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- FDI Clinical Research
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 5 Jun 2019 (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 pilot project will determine whether a diet culturally-adapted to Puerto Ricans can effectively decrease cardiometabolic risk for diabetes. This will help define a culturally-appropriate, feasible, and sustainable diet intervention aimed at reducing type 2 diabetes and obesity outcomes.
Detailed description
This pilot 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 4-month, 2-arm intervention among 200 adults (100 per arm) ages 25-65 living in Puerto Rico with at least 2 of 5 cardiometabolic risk factors. The two arms are: (1) intervention group consisting of culturally-appropriate advice in an initial individual session with daily text messages for 2 months (delivery phase); (2) control arm of standard general nutritional advice at the initial individual session, and text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. Investigators will measure changes in cardiometabolic risk factors and in eating-behaviors and psychological measures.
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 consisting of culturally-appropriate foods and diet advice in an initial individual session followed by daily text messages for 2 months (delivery phase). A reinforcement phase of 2-months will follow to repeat the text messages. |
| Control | Active comparator | Behavioral: Standard healthy eating adviceControl arm of standard portion-control general nutritional and cooking advice at the initial individual session, followed by text messages for 2 months. A reinforcement phase of 2-months will follow to repeat the education and text messages. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 25-65 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 6 months
- Able to answer questions without assistance
- Having a cellphone with the capacity to receive text messages
Key exclusion criteria (9 listed)
- Under 25 or over 65 years of age
- Currently do not live in Puerto Rico or have not lived in PR for at least 1 year or plan to move within 6 months
- Institutionalized
- Not able to answer questions without assistance
- Not having at least 2 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 dietary recommendations | Behavioural | Control |
Primary outcome
Number of dysregulated cradiometabolic risk factors
Time frame: 4 months
Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values)
Change in levels of adipose risk factor
Time frame: 4 months
Estimate the change in the value of waist circumference (cm)
Change in levels of blood pressure risk factors
Time frame: 4 months
Estimate the change in the value of systolic and diastolic blood pressure (mmHg)
Change in levels of metabolic risk factors
Time frame: 4 months
Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL)
2 secondary outcomes
Changes in diet quality score
Time frame: 4 months
Changes in diet satisfaction: diet satisfaction scale
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Derived from this study: PubMed 37181130Mattei J, Diaz-Alvarez CB, Alfonso C, O'Neill HJ, Rios-Bedoya CF, Malik VS, Godoy-Vitorino F, Cheng C, Spiegelman D, Willett WC, Hu FB, Rodriguez-Orengo JF. Design and Implementation of a Culturally-Tailored Randomized Pilot Trial: Puerto Rican Optimized Mediterranean-Like Diet. Curr Dev Nutr. 2022 Dec 23;7(1):100022. doi: 10.1016/j.cdnut.2022.100022. eCollection 2023 Jan.
- 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.
Related trials for Diabetes Mellitus, Type 2
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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. This study is not recruiting at the moment.
Jose F Rodriguez Orengo, PhD study director
FDI Clinical Research
Josiemer Mattei, PhD, MPH principal investigator
Harvard Chan School of Public Health
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 9 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: finished, as of the sponsor's last update on 23 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dysregulated cradiometabolic risk factors (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975556, which also lists 1 linked publication.
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 23 Jul 2021.