Culturally-Adapted Diet for Puerto Rican Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Culturally-Adapted Diet for Puerto Rican Adults

Conditions
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Diabetes Mellitus, Type 2, Obesity, Hypertension, Dyslipidemias, High Triglycerides, High Blood Glucose, Abdominal Obesity

Intervention / Treatment
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* Behavioral: Culturally tailored food and diet advice
* Behavioral: Standard healthy eating advice


Participation Criteria
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Eligibility Criteria
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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: 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 Exclusion Criteria: 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. Self-reported pregnancy Gastrointestinal or chronic conditions Food intolerance or allergies

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Behavioral: Culturally tailored food and diet advice<br>* Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.<br>|
| Active Comparator: Control<br>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. | Behavioral: Standard healthy eating advice<br>* Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |