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| Name | Class |
|---|---|
| FDI Clinical Research | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culturally tailored food and diet advice | Behavioral | Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of dysregulated cradiometabolic risk factors | Estimate the change in the number of dysregulated cradiometabolic risk factors (outside of normal values) | 4 months |
| Change in levels of adipose risk factor | Estimate the change in the value of waist circumference (cm) | 4 months |
| Change in levels of blood pressure risk factors | Estimate the change in the value of systolic and diastolic blood pressure (mmHg) | 4 months |
| Change in levels of metabolic risk factors | Estimate the change in the value of glucose, HDL, and triglycerides (mg/dL) | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in diet quality score | Determine the change in score of short diet quality screener (range 18-54; from lowest to highest quality) | 4 months |
| Changes in diet satisfaction: diet satisfaction scale |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose F Rodriguez Orengo, PhD | FDI Clinical Research | Study Director |
| Josiemer Mattei, PhD, MPH | Harvard Chan School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FDI Clinical Research | San Juan | 00969 | Puerto Rico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37181130 | Derived | 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. |
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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.
1-year
The requested data will be shared with investigators via a secured, password-protected software website, upon request.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| D015228 | Hypertriglyceridemia |
| D006943 | Hyperglycemia |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Participants will be unaware of the 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.
| Standard healthy eating advice | Behavioral | Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations |
|
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)
| 4 months |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D006949 | Hyperlipidemias |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |